A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi®

A Randomized, Double-blind, Single-dose, Parallel Three-arm Comparative Study on Pharmacokinetics and Safety of BAT2506 Injection Versus the EU-licensed and US-licensed Simponi® in Healthy Chinese Male Subjects

This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male subjects.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: BAT2506 injection; Drug: Simponi® (EU commercially available product); Drug: Simponi® (US commercially available product)

Detailed Description

This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male subjects.

The study planes to enroll 375 healthy male subjects who will be randomly assigned to the BAT2506 Injection group, Simponi® (EU-licensed) or Simponi® (US-licensed) groups in a 1:1:1 ratio to receive a single subcutaneous injection of 50 mg BAT2506 Injection or Simponi® (EU-licensed or US-licensed).

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • The First Bethune Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1)Signed the ICF and fully understood the trial conduction, procedure and potential adverse reactions before included the trial;
• 2)Able to complete the study in accordance with the requirements of the protocol;
• 3)Subjects (including their partners) who are willing to refrain from pregnancy and will not donate sperm throughout the trial and within 6 months after the end of the study, and willing to take effective contraceptive method, see Appendix 4 for specific contraceptive methods;
• 4)Healthy male subjects at age of 18-55 years with a body mass index (BMI) between 18 and 28 kg/m2 (inclusive) and a body weight between 50 and 80 kg (inclusive);
• 5)Subjects with normal physical examination and vital signs or non-clinically significant abnormalities.

Subjects with normal abdominal color Doppler ultrasound, laboratory tests and other examination results or non-clinically significant abnormalities.

Exclusion Criteria:

• 1)Subjects who smoked more than 5 cigarettes every day within 3 months prior to the trial;
• 2)Subjects with a history of allergies to the study drug, or subjects with allergic constitution (allergic to a variety of drugs and foods);
• 3)Subjects with a history of alcohol abuse (consuming 14 or more units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
• 4)Subjects who donated blood within 3 months prior to screening or plan to donate blood during the study period;
• 5)Subjects who had major injuries or underwent surgery or had fractures within 4 weeks prior to enrollment, or who are scheduled to undergo surgery during the study period;
• 6)Subjects whose abnormalities in past medical history are clinically significant or other clinical findings suggest the following clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, blood, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases);
• 7)Subjects who suffered from malignant tumors (excluding those with basal cell carcinoma which has been surgically resected);
• 8)Subjects with clinically significant chronic or acute infections at screening/enrollment, or with active infections, including acute and chronic infections and local infections (bacteria, viruses, parasites, fungi or other pathogens of opportunistic infectious diseases);
• 9)Patients having a history of tuberculosis, or having latent tuberculosis infection or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis);
• 10)Subjects who have contacted with tuberculosis patients or/and had symptoms and/or signs suspected of being tuberculosis within 3 months prior to screening ;
• 11)Subjects who have used Simponi®, any anti-tumor necrosis factor (TNF-α) biologic, or have used any biologics or monoclonal antibodies within 6 months prior to enrollment ;
• 12)Subjects who have used drugs (including but not limited to prescription drugs, traditional Chinese medicines, over-the-counter drugs, etc.) within 30 days prior to enrollment ;
• 13)Subjects who have participated in other drug clinical trials within 3 months prior to enrollment;
• 14)Have received live vaccine within 12 weeks prior to study administration or plan to receive live vaccine during study period; Have received inactivated vaccine (including COVID-2019 inactivated vaccine) within 2 weeks prior to administration or plan to receive inactivated vaccine during study period.
• 15)Subjects with a history of hypertension or systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg at screening/enrollment, which is judged to be a clinically significant abnormality;
• 16)Subjects with clinically significant abnormalities in ECG;
• 17)Positive hepatitis B surface antigen at screening [or negative hepatitis B surface antigen and meeting all three of the following: positive hepatitis B core antibody, negative hepatitis B surface antibody, and hepatitis B virus deoxyribonucleic acid (HBV DNA) levels exceed the normal quantification range]; or positive hepatitis C antibody, hepatitis C core antigen, HIV antigen/antibody, or positive syphilis spirochete antibody;
• 18)Subjects with clinically significant abnormalities in frontal chest radiography;
• 19)Those who have tested positive for enzyme-linked immunospot assay (T-SPOT. TB);
• 20)Subjects who have taken any alcoholic products within 24 hours prior to the use of the study drugs;
• 21)Those who have tested positive for drug abuse or have a history of drug abuse within past five years;
• 22)Ineligible subjects based on investigator's judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAT2506; BAT2506 injection, 50 mg, subcutaneous administration. Dose regimen: 50 mg/0.5 mL/syringe, subcutaneously injected at the lower abdomen, except for the 5 cm area around the navel. Do not inject into skin that is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch mark.	Drug: BAT2506 injection; 50 mg, subcutaneous administration
Active Comparator: Simponi® (EU commercially available product); 50 mg, subcutaneous administration Dose regimen: 50 mg/0.5 mL/syringe, subcutaneously injected at the lower abdomen, except for the 5 cm area around the navel. Do not inject into skin that is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch mark.	Drug: Simponi® (EU commercially available product); 50 mg, subcutaneous administration
Active Comparator: Simponi® (US commercially available product); 50 mg, subcutaneous administration Dose regimen: 50 mg/0.5 mL/syringe, subcutaneously injected at the lower abdomen, except for the 5 cm area around the navel. Do not inject into skin that is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch mark.	Drug: Simponi® (US commercially available product); 50 mg, subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak plasma concentration	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
AUC0-∞	area under the drug concentration-time curve	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(AUC0-t)	Area under the drug concentration-time curve from time 0 to the last quantifiable data point	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
temperature	number of participants with abnormal temperature findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
pulse	number of participants with abnormal pulse findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
blood pressure	number of participants with abnormal blood pressure findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
skin mucosa	number of participants with abnormal skin mucosa findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
lymph nodes	number of participants with abnormal lymph nodes findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
head and neck	number of participants with abnormal head and neck findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
chest	number of participants with abnormal chest findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
abdomen	number of participants with abnormal abdomen findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
spine/extremities	number of participants with abnormal spine/extremities findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
heart rate	number of participants with abnormal heart rate findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
PR Interval	number of participants with abnormal PR Interval findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
RR Interval	number of participants with abnormal RR Interval findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
QRS Interval	number of participants with abnormal QRS Interval findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
QT Interval	number of participants with abnormal QT Interval findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
QTc interval	number of participants with abnormal QTc Interval findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
hematology,	Number of participants with abnormal hematology findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
biochemistry	Number of participants with abnormal biochemistry findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
coagulation routine	Number of participants with abnormal coagulation routine findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
urinalysis	Number of participants with abnormal urinalysis findings	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
Injection-site reaction Injection-site reaction	Injection-site reaction Adverse events (AE), serious adverse events (SAE), etc.	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
Adverse events (AE)	Adverse events (AE), serious adverse events (SAE)	on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78

Collaborators and Investigators

• Sponsor: Bio-Thera Solutions
• Collaborators: The First Hospital of Jilin University
• Investigators: Principal Investigator: Yanhua Ding, Doctor, The First Hospital of Jinlin University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Arthritis; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis, Psoriatic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Antibodies, Monoclonal; Golimumab
• Other Study ID Numbers: BAT-2506-003-CR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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