- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04828343
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
July 27, 2023 updated by: UCB Biopharma SRL
A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous (SC) dose of rozanolixizumab administered to healthy participants by manual push (MP) versus (vs) syringe driver.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom
- Up0106 001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Study participant must be 18 to 65 years of age, inclusive
- Study participants who are overtly healthy in the opinion of the investigator as determined by medical evaluation including medical history, a general clinical examination, including physical examination and laboratory tests, and cardiac monitoring
- Study participant has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes of rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse: 40 to 90 beats per minute (bpm))
- Study participant has clinical laboratory test results within the reference ranges of the testing laboratory or not clinically significant if outside the specified ranges, in the opinion of the investigator
- Study participant's electrocardiogram (ECG) is considered "normal" or "abnormal but clinically nonsignificant" (as interpreted by the investigator)
- Study participants may be male or female
- Participant has a body mass index of 18 to 32 kg/m^2, with a minimum body weight of 35 kg
Exclusion Criteria:
- History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders. Has active neoplastic disease or history of neoplastic disease within the previous 5 years of entry in the clinical study (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care approaches). Has a history of a major organ transplant or hematopoietic stem cell/marrow transplant
- Symptomatic herpes zoster within 3 months prior to Screening
- Allergies to humanized monoclonal antibodies
- Female who is pregnant or lactating
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination
- Predicted inability to comply with being free of caffeine and ethanol from 72 hours prior to clinic admission and during the In-Clinic Period of the study
- Known hypersensitivity to oral paracetamol (acetaminophen)
- History of known inflammatory bowel disease, active diverticular disease, or a history of confirmed duodenal, gastric, or esophageal ulceration in the previous 6 months
- History of hyperprolinemia, since L-proline is a constituent of rozanolixizumab.
- Twelve-lead ECG with abnormalities considered to be clinically significant upon medical review
- Renal impairment, defined as a creatinine concentration in serum of ≥1.4 mg/dL (≥123 μmol/L) for female participants and ≥1.5 mg/dL (≥132 μmol/L) for male participants
- Known viral hepatitis (B and C) or human immunodeficiency virus 1/2 antibodies or has a past medical history or family history of primary immunodeficiency or antibodies to human immunodeficiency virus type 1 and/or type 2 at Screening
- Participant has a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in reverse transcriptase-polymerase chain reaction on admission to the unit
- Participant has clinical signs and symptoms consistent with SARS-CoV-2 (eg, fever, dry cough, dyspnea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the previous 14 days prior to Screening or on admission
- Participant has active infection or is symptomatic with SARS-CoV-2 or is currently in quarantine (has been in contact with a SARS-CoV-2 positive individual in the last 14 days)
- Participant has had a severe course of SARS-CoV-2 (eg, requiring extracorporeal membrane oxygenation, mechanical ventilation, or hospitalization)
- Past or intended use of over-the-counter or prescription medication (including herbal medications) within 14 days prior to dosing until Day 57
- Live vaccine(s) within 8 weeks prior to Screening or plans to receive such vaccines during the study or is within a dosing cycle to receive a second dose of a coronavirus disease-19 (COVID-19) vaccine, or within 2 weeks of having received a COVID-19 vaccine
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- Exposure to more than 3 new chemical entities within 12 months prior to dosing
- Has previously been assigned to treatment in a clinical study of rozanolixizumab
- Participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 90 days or 5 half-lives prior to Day -1 (whichever is longer) or is currently participating in another study of an IMP (or a medical device)
- Immunoglobulin G <7g/L or >16g/L at the Screening Visit
- Participant is splenectomized or has had an active clinically significant infection within the last 6 weeks
- Donated or lost >500 mL of blood or blood products in the 3 months preceding the start of dosing or plans to donate blood during the clinical study
- Employee or direct relative of an employee of the contract research organization (CRO) or UCB
- History of alcohol and/or drug abuse up to 12 months before Screening
- Smoked on average >5 cigarettes/day (or equivalent) during the last 3 months and is not able to stop smoking during the In-Clinic Period
- Excessive consumption of beverages or food containing xanthine bases (including caffeinated drinks, coffee, chocolate, etc.), equating to >400 mg caffeine per day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1 <50 kg
Study participants randomized to Cohort 1 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered with a syringe driver.
|
Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.
Other Names:
Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.
Other Names:
|
Experimental: Cohort 2 <50 kg
Study participants randomized to Cohort 2 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered by manual push.
|
Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.
Other Names:
Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.
Other Names:
|
Experimental: Cohort 3 >=50 kg
Study participants randomized to Cohort 3 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered with a syringe driver.
|
Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.
Other Names:
Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.
Other Names:
|
Experimental: Cohort 4 >=50 kg
Study participants randomized to Cohort 4 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered by manual push.
|
Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.
Other Names:
Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
|
A TEAE was defined as any adverse event (AE) with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication.
|
From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab
Time Frame: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
|
Cmax was the maximum plasma concentration of a single dose rozanolixizumab.
Cmax was measured in micrograms per millilitre per milligram (ug/mL/mg).
|
Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
|
Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab
Time Frame: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
|
tmax was the time to maximum plasma concentration of a single dose rozanolixizumab.
|
Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab
Time Frame: Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
|
AUC0-t was the area under the plasma concentration-time curve from time zero to time t of a single dose rozanolixizumab.
|
Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16
|
Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve
Time Frame: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
|
Area under the baseline-corrected total IgG response curve from time 0 to time t.
|
Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
|
Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo
Time Frame: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
|
Rmin was the maximum (max) decrease in total plasma IgG of a single dose rozanolixizumab or placebo.
|
Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
|
Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo
Time Frame: Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
|
tmin was the time to minimum IgG level of a single dose rozanolixizumab or placebo.
|
Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: UCB Cares, 001 844 599 2273
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 22, 2021
Primary Completion (Actual)
April 11, 2022
Study Completion (Actual)
April 11, 2022
Study Registration Dates
First Submitted
March 30, 2021
First Submitted That Met QC Criteria
March 30, 2021
First Posted (Actual)
April 2, 2021
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
July 27, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP0106
- 2020-005973-28 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified.
For this reason, data from this trial cannot be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Study Participants
-
UCB Biopharma SRLRecruiting
-
AstraZenecaParexelCompletedHealthy Participants StudyGermany, United States, United Kingdom
-
UCB Biopharma SRLCompletedHealthy Study ParticipantsUnited Kingdom
-
AstraZenecaRecruitingHealthy Participants StudyUnited States
-
UCB Biopharma SRLTerminatedHealthy Study ParticipantsGermany
-
UCB Biopharma SRLCompletedHealthy Study ParticipantsUnited States
-
UCB Biopharma SRLCompletedHealthy Study ParticipantsUnited States, Germany
-
UCB Biopharma S.P.R.L.TerminatedHealthy Study ParticipantsUnited Kingdom
-
Bristol-Myers SquibbCompletedPharmacokinetic Study in Healthy ParticipantsUnited States
-
UCB Biopharma S.P.R.L.TerminatedImpaired Hepatic Function | Healthy Study ParticipantsUnited States
Clinical Trials on rozanolixizumab
-
UCB Biopharma SRLActive, not recruiting
-
UCB Biopharma SRLNot yet recruitingGeneralized Myasthenia Gravis
-
UCB Biopharma SRLParexelCompletedThrombocytopeniaAustralia, Bulgaria, Czechia, Georgia, Germany, Italy, Moldova, Republic of, Poland, Romania, Spain, United Kingdom
-
UCB Biopharma SRLCompletedGeneralized Myasthenia GravisUnited States, Canada, Czechia, Denmark, France, Georgia, Germany, Italy, Japan, Poland, Russian Federation, Serbia, Spain, Taiwan
-
UCB Biopharma SRLCompletedGeneralized Myasthenia GravisUnited States, Canada, Czechia, Denmark, France, Germany, Italy, Japan, Poland, Russian Federation, Spain, Taiwan
-
UCB Biopharma SRLActive, not recruitingGeneralized Myasthenia GravisUnited States, Canada, Georgia, Germany, Italy, Japan, Poland, Serbia, Spain, United Kingdom
-
UCB Biopharma SRLTerminatedPrimary Immune ThrombocytopeniaUnited States, China, Georgia, Germany, Hungary, Italy, Japan, Moldova, Republic of, Poland, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom
-
UCB Biopharma SRLCompletedChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)United States, Belgium, Denmark, France, Germany, Netherlands, Spain, United Kingdom
-
UCB Biopharma SRLNo longer availableChronic Inflammatory Demyelinating Polyneuropathy (CIDP)
-
UCB Biopharma SRLTerminatedPrimary Immune ThrombocytopeniaUnited States, Bulgaria, France, Georgia, Greece, Hungary, Italy, Japan, Korea, Republic of, Moldova, Republic of, Poland, Romania, Russian Federation, Taiwan, Ukraine, United Kingdom