Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants

A First-in-human, Randomized, Double-blind, Parallel-group Study to Evaluate the PK, Safety, Tolerability, Immunogenicity, and PD Profile of a Single Intravenous Dose of TUR03 Compared With Soliris® in Healthy Adult Male Participants

This study is designed as a randomized, double-blind, parallel-group study to evaluate the PK, safety, tolerability, immunogenicity, and PD of TUR03 compared to Soliris, when administered as a single IV infusion in healthy adult male participants.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Soliris 300 MG in 30 ML Injection; Drug: TUR03 300 MG in 30 ML Injection

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia
      • Recruiting
      • Q-Pharm Pty Limited
      • Contact: Complaints Officer; Phone Number: 1800 243 733; Email: complaintsofficer@nucleusnetwork.com.au
      • Contact: Privacy Officer; Email: privacyofficer@nucleusnetwork.com.au
      • Principal Investigator: Kristi Mc Lendon, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Participants are eligible to be included in the study only if ALL of the following criteria apply:

1. Capable of giving signed informed consent as described in Section 10.1, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
2. Participants assigned male at birth who are ≥18 years and ≤45 years old at the time of signing the ICF.
3. Body weight ≥50 kg and ≤90 kg and body mass index (BMI) ≥18.00 kg/m2 and ≤30.00 kg/m2 at Screening and Day -1.

4. Participants must be healthy as determined by the Investigator, based on medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations at Screening and Day -1, as follows:

   1. Hematology and coagulation results within reference ranges.
   2. Liver function panel analyte values ≤1.5 × upper limits of normal (ULN), which include aspartate transaminase, alanine transaminase, and total bilirubin (for participants with Gilbert's Syndrome, total bilirubin ≤3.0 × ULN is allowed if direct bilirubin is ≤50%), alkaline phosphatase, and gamma glutamyl transferase at Screening.
   3. Urinalysis within reference ranges or showing no clinically significant findings.

   NOTE: One repeat of clinical laboratory tests is allowed at the discretion of the Investigator.

5. Participants must have documented evidence of prior complete vaccination with meningococcal vaccines against N. meningitidis serogroup B at any time and against serogroups A, C, W, and Y within 5 years prior to Screening in line with local immunization requirements or must agree to be vaccinated against N. meningitidis during the study.
6. Nonsterilized participants with partners of childbearing potential must agree to take appropriate contraceptive measures (as described in Section 10.4) from Day 1 until 5 months after IP administration and refrain from donating sperm during this period. NOTE: Participants with pregnant partners are excluded.
7. Nonsmoker or occasional smoker, ie, smokes ≤10 cigarettes (or equivalent of tobacco- or nicotine-containing products) per week within 30 days prior to Screening and is able to abide by the smoking policy of the study site.
8. Ability and willingness to abstain from alcohol from 48 hours before admission to the study site on Day -1, during in-house observation at the study site until discharge, and for 24 hours prior to ambulatory visits.

Exclusion Criteria:

Participants are excluded from the study if ANY of the following criteria apply:

1. Known or suspected hereditary or acquired complement deficiency.
2. History of meningococcal infection.
3. History or evidence of a clinically significant disorder (including psychiatric disorders), condition, or disease that, in the opinion of the Investigator and Medical Monitor or designee, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. EXCEPTION: Fully resolved childhood asthma is not exclusionary.
4. History of splenectomy.
5. History of surgery or major trauma within 12 weeks of Screening, or surgery planned during the study.
6. A recent history (within 1 week prior to IP administration) or presence or suspicion of current active systemic or local infection, a known risk for developing sepsis, and/or known active inflammatory condition, in the opinion of the Investigator.
7. History of or current invasive malignancy (excluding basal or squamous cell carcinoma that has been fully resected with no evidence of metastatic disease for 1 year).
8. History of ongoing seborrheic dermatitis or eczema.
9. History of clinically significant headaches that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
10. History of recurrent/chronic hemorrhages or any hemorrhage within 30 days prior to IP administration.
11. History of a drug- or food-induced severe hypersensitivity reaction (eg, immunologic or nonimmunologic anaphylaxis).
12. Known hypersensitivity reaction to penicillin and/or cephalosporin that, in the opinion of the Investigator, would pose a risk to participant safety.
13. Known hypersensitivity to any component of TUR03 or Soliris, murine proteins, or other monoclonal antibodies.
14. Known hypersensitivity to any component of meningococcal vaccines, including those containing diphtheria toxoid, or a life-threatening reaction after previous administration of a vaccine containing similar components.
15. Hypertension at Screening or Day -1 (defined as a systolic blood pressure [BP] >140 mm Hg and/or a diastolic BP >90 mm Hg, confirmed by a single repeat measurement that same day) or a history of hypertension requiring pharmacological intervention.
16. Proteinuria at Screening or Day -1 (with a urine dipstick value of 1+ or above)..
17. Tests positive for human immunodeficiency virus (HIV 1 and 2), hepatitis B virus surface antigen, hepatitis B core antibody, or hepatitis C virus.
18. Tests positive for tuberculosis (TB) using the QuantiFERON®-TB Gold test at Screening or, if indeterminant result on the first test, tests positive or indeterminant on repeat QuantiFERON-TB Gold test.
19. Positive screen for alcohol by breath test and/or potential drugs of abuse by urine drug screen at Screening or Day -1. NOTE: One repeat screen is allowed at the discretion of the Investigator.
20. History of alcohol or drug abuse or drug addiction (including cannabis products) within the last 12 months prior to Screening.
21. Prior exposure to eculizumab or similar compounds (ie, a monoclonal antibody that specifically binds to the complement protein C5).
22. Use of immunoglobulins or iron supplementation within 3 months prior to Screening.
23. Use of any over-the-counter (OTC) medications, herbal remedies such as St. John's Wort extract, or prescription medications within 7 days or 5 half lives (whichever is longer) prior to IP administration. EXCEPTIONS: Vitamins, dietary supplements, and paracetamol (up to 4 g per day, but <1 g in 4 hours) for analgesia are not exclusionary.
24. Use of other investigational drugs (or is currently using an investigational device) within 60 days or 5 half-lives (whichever is longer) prior to IP administration.
25. Vaccination with a live vaccine within 30 days prior to IP administration, or vaccination with an inactivated vaccine or approved COVID-19 vaccine within 14 days prior to IP administration, or planning to get vaccinated during the study period. EXCEPTIONS: Receipt of required meningococcal vaccinations per protocol is not exclusionary.
26. Veins unsuitable for venous blood collection.
27. Donated blood (including blood products) or experienced loss of blood ≥500 mL within 30 days of Screening, or donated plasma within 7 days of Screening.
28. Participant is a family member or employee of the Investigator or Sponsor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Soliris	Drug: Soliris 300 MG in 30 ML Injection; Active Comparator
Experimental: TUR03	Drug: TUR03 300 MG in 30 ML Injection; Investigational medicinal Product, eculizumab - Turgut

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK similarity of TUR03 and Soliris following a single IV infusion in healthy participants	The primary endpoint for PK similarity is AUC(0-inf).	Day 1 - Day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eculizumab serum concentration-time profile	Serum eculizumab concentrations will be listed and summarized using descriptive statistics by treatment group and nominal PK sampling time point. All serum eculizumab concentrations that are below the limit of quantification will be labeled as such in the concentration data listings. Individual and arithmetic mean (per treatment) concentration-time profiles will also be presented graphically.	Day 1 - Day 57
Maximum serum concentration (Cmax)	Observed concentration versus time data	Day 1- Day 57
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)	AUC(0-last)	Day 1- Day 57
Time to Cmax	tmax	Day 1 - Day 57
Terminal half-life	t½	Day 1 - Day 57
Volume of distribution during terminal phase after intravenous administration	Vz	Day 1 - Day 57
Terminal elimination rate constant	Kel	Day 1 - Day 57
Total serum clearance of drug after intravenous administration	CL	Day 1 - Day 57
AEs and AESI	infusion-related reactions, meningococcal infections, and other serious systemic infections	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Hematology	Platelet count, Red blood cell count, Neutrophils, Hemoglobin, Lymphocytes, Hematocrit, Monocytes, Eosinophils, Mean corpuscular volume, Basophils, Mean corpuscular hemoglobin, Mean cell hemoglobin concentration will be measured to assess changes in hematological parameters in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - International normalized ratio	International normalized ratio (INR) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - Activated partial thromboplastin time	Activated partial thromboplastin time (sec) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Coagulation - Prothrombin time	Prothrombin time (sec) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Urea	Urea (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Carbon dioxide (bicarbonate)	Carbon dioxide (bicarbonate)(mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Creatinine	Creatinine (mcmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - AST	AST (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - ALT	ALT (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - ALP	ALP (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Glucose (fasting)	Glucose (fasting)(mcmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Gamma glutamyl transferase	Gamma glutamyl transferase (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Total Protein	Total protein (g/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Creatine kinase	Creatine kinase (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Potassium	Potassium (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Lactate dehydrogenase	Lactate dehydrogenase (U/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Sodium	Sodium (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Albumin	Albumin (g/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Chloride	Chloride (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Total and direct bilirubin	Total and direct bilirubin (mcmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Calcium	Calcium (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Triglycerides	Triglycerides (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Phosphate	Phosphate (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Clinical chemistry - Cholesterol	Cholesterol (mmol/L) will be measured in blood samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Leukocytes	Leukocytes, will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Red blood cells	Red blood cells (/hpf) will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Protein	Protein (mg/dL) will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - pH	pH will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Bilirubin	Bilirubin will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Nitrite	Nitrite will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Urobilinogen	Urobilinogen (EU/dl) will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Specific gravity	Specific gravity will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Ketones	Ketones (mg/dL) will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Glucose	Glucose (mg/dL) will be measured to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Incidence of Treatment-Emergent changes in safety clinical laboratory parameters from baseline and Grade 3 laboratory abnormalities - Urinanalysis - Microscopy	Microscopic (if clinically indicated)(/hpf) analyses to assess changes in urine-related parameters in urine samples. Any clinically significant pathology results (that require reporting as an adverse event) will be incorporated into the adverse event table.	Day 1 - Day 57
Changes in vital signs - Blood Pressure	Systolic and diastolic blood pressure will be assessed with a completely automated device. Wherever possible, vital signs measurements must be taken using the same body position at subsequent visits and consistent methods between participants.	Day 1 - Day 57
Changes in vital signs - Pulse rate	Pulse rate will be assessed with a completely automated device. Wherever possible, vital signs measurements must be taken using the same body position at subsequent visits and consistent methods between participants.	Day 1 - Day 57
Changes in vital signs - Body Temperature	Body temperature (aural is preferred), will be assessed with a completely automated device. Wherever possible, vital signs measurements must be taken using the same body position at subsequent visits and consistent methods between participants.	Day 1 - Day 57
Changes in Electrocardiograms (ECG) - Heart rate	Single 12-lead ECGs will be obtained after the participant has rested comfortably in the supine position for at least 5 minutes in a quiet setting without distractions (eg, television, cell phones) using an ECG machine that automatically calculates the heart rate. All ECG data will be documented at each prespecified time point, and the details will be recorded in both the source documents and the eCRF. The Investigator (or a qualified delegate at the investigational site) will interpret the ECG using 1 of the following categories: normal, abnormal not clinically significant, or abnormal clinically significant and record their evaluation in the eCRF.	Day 1 - Day 57
Changes in Electrocardiograms (ECG) - PR interval	Single 12-lead ECGs will be obtained after the participant has rested comfortably in the supine position for at least 5 minutes in a quiet setting without distractions (eg, television, cell phones) using an ECG machine that automatically measures PR interval. All ECG data will be documented at each prespecified time point, and the details will be recorded in both the source documents and the eCRF. The Investigator (or a qualified delegate at the investigational site) will interpret the ECG using 1 of the following categories: normal, abnormal not clinically significant, or abnormal clinically significant and record their evaluation in the eCRF.	Day 1 - Day 57
Changes in Electrocardiograms (ECG) - RR interval	Single 12-lead ECGs will be obtained after the participant has rested comfortably in the supine position for at least 5 minutes in a quiet setting without distractions (eg, television, cell phones) using an ECG machine that automatically measures RR interval. All ECG data will be documented at each prespecified time point, and the details will be recorded in both the source documents and the eCRF. The Investigator (or a qualified delegate at the investigational site) will interpret the ECG using 1 of the following categories: normal, abnormal not clinically significant, or abnormal clinically significant and record their evaluation in the eCRF.	Day 1 - Day 57
Changes in Electrocardiograms (ECG) - QRS duration	Single 12-lead ECGs will be obtained after the participant has rested comfortably in the supine position for at least 5 minutes in a quiet setting without distractions (eg, television, cell phones) using an ECG machine that automatically measures QRS duration. All ECG data will be documented at each prespecified time point, and the details will be recorded in both the source documents and the eCRF. The Investigator (or a qualified delegate at the investigational site) will interpret the ECG using 1 of the following categories: normal, abnormal not clinically significant, or abnormal clinically significant and record their evaluation in the eCRF.	Day 1 - Day 57
Changes in Electrocardiograms (ECG) - QT interval	Single 12-lead ECGs will be obtained after the participant has rested comfortably in the supine position for at least 5 minutes in a quiet setting without distractions (eg, television, cell phones) using an ECG machine that automatically measures QT interval. The QT interval corrected for heart rate by Fridericia's formula (QTcF interval) will be derived. All ECG data will be documented at each prespecified time point, and the details will be recorded in both the source documents and the eCRF. The Investigator (or a qualified delegate at the investigational site) will interpret the ECG using 1 of the following categories: normal, abnormal not clinically significant, or abnormal clinically significant and record their evaluation in the eCRF.	Day 1 - Day 57
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 via physical examination	Complete physical examination will be performed by a study-delegated registered physician at Screening and will include, at a minimum, assessments of general appearance, head, ears, eyes, nose, throat, neck (including thyroid), skin, cardiovascular system, respiratory, system, gastrointestinal system, musculoskeletal system, lymph nodes, and nervous system. A brief physical examination will be performed at specified time points outlined in the SoA and will include, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). A symptom-directed physical examination, including areas with previously noted abnormalities and/or that are associated with any new complaints from the participant, will be performed at all other visits and at any time throughout the study, as clinically indicated.	Day 1 - Day 57
Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Frequency of antidrug antibodies (ADAs)	Frequency of ADAs will be assessed. Serum samples will be screened for antibodies binding to eculizumab in TUR03 and Soliris. The detection and characterization of ADAs to eculizumab will be performed using validated immunoassay methods.	Day 1 - Day 57
Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Antidrug antibody titers	Titers of ADAs will be assessed.	Day 1 - Day 57
Comparison of the immunogenicity of TUR03 and Soliris following a single IV infusion in healthy participants - Neutralizing antibodies (NAbs)	The frequency of NAbs will be assessed in ADA-positive participants' sera. Subsequent to the confirmation of ADA-positivity, antibodies will be further characterized and evaluated for their ability to neutralize the activity of the IP (TUR03 and Soliris).	Day 1 - Day 57
PD profile of TUR03 and Soliris - ABEC (0-1344) CH50	Area between the baseline and effect curves for hemolytic complement activity from 0 to 1344 hours	Day 1 - Day 57
PD profile of TUR03 and Soliris - AUEC(0-1344) CH50	Area under the effect curve for hemolytic complement activity from 0 to 1344 hours	Day 1 - Day 57
PD profile of TUR03 and Soliris - Emin CH50	Minimum hemolytic complement activity from 0 to 1344 hours	Day 1 - Day 57
PD profile of TUR03 and Soliris - Tmin CH50	Time to minimum hemolytic complement activity from 0 to 1344 hours	Day 1 - Day 57

Collaborators and Investigators

• Sponsor: Turgut Ardika PTY LTD

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Anticipated): September 23, 2023
• Study Completion (Anticipated): April 5, 2024

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: phase I; biosimilar; eculizumab
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Complement Inactivating Agents; Eculizumab
• Other Study ID Numbers: TUR03-22-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No