A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: BIIB133 (Dapirolizumab pegol)Drug: Placebo
- Registration Number
- NCT04571424
- Lead Sponsor
- Biogen
- Brief Summary
The primary objective of the study is to assess the safety and tolerability of a single intravenous (IV) dose of dapirolizumab pegol (DZP) in Japanese healthy study participants compared with those of Caucasian healthy study participants.
The secondary objectives of the study are to assess the pharmacokinetic(s) (PK) of a single IV dose of DZP in Japanese and Caucasian healthy study participants, to evaluate ethnic sensitivity on the PK of DZP between body weight- and gender-matched Japanese and Caucasian healthy study participants and to evaluate the immunogenicity of a single IV dose of DZP in Japanese and Caucasian healthy study participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 14 days of Day -1 (inclusive).
- Japanese study participant has both biological parents and all 4 grandparents of Japanese descent and, if living outside of Japan for more than 5 years, must maintain a Japanese diet.
- Caucasian study participant has both biological parents and all 4 grandparents of Caucasian descent.
- Have a body weight between 50 and 90 kilograms (kg) (inclusive) and body mass index (BMI) between 18.0 and 26.0 kilograms per meter square (kg/m^2) (inclusive) at the Screening Visit.
Key
Exclusion Criteria
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- Have undergone major surgery in the last 6 months or plans to undergo elective major surgery during the study period.
- Have a known hypersensitivity to any components or excipients of DZP including polyethylene glycol (PEG).
- Have received any prescription or nonprescription medicines including over-the-counter remedies and herbal and dietary supplements within 14 days or 5 half-lives of the respective drug, whichever is longer, other than acetaminophen and antihistamines.
- Current enrollment in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer.
- History of chronic, recurrent, or recent (within 6 months prior to Screening) severe infection and/or at risk for severe infection, as determined by the Investigator.
- Have symptoms consistent with SARS-CoV-2 infection, per the judgement of the Investigator, within 14 days prior to Day -1, including but not limited to fever (temperature > 37.5 degree Celsius [°C]), sore throat, new and persistent cough, breathlessness, or loss of taste or smell.
- Have close contact within 14 days prior to Day -1 with a SARS-CoV-2 (+) individual. Close contact is defined as (1) being within 6 feet of an infected individual (as confirmed via laboratory assessment) for at least 15 minutes within 2 days of symptom onset or (2) being within 6 feet of an asymptomatic infected individual for at least 15 minutes within 2 days of that asymptomatic individual undergoing specimen collection for SARS-CoV-2 testing.
- Clinically significant abnormal laboratory test result values, as determined by the Investigator, at Screening or Day -1.
- Have received any live/attenuated vaccination within 6 weeks prior to Visit 2 (Day 1) or plans to receive any live/attenuated vaccination within 120 days after the dose of study treatment.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1: BIIB133 Dose 1 BIIB133 (Dapirolizumab pegol) Participants will receive single IV infusion of BIIB133 Dose 1. Cohort 2: BIIB133 Dose 2 BIIB133 (Dapirolizumab pegol) Participants will receive single IV infusion of BIIB133 Dose 2. Cohort 1-2: Placebo Placebo Participants will receive single IV infusion of matching placebo to BIIB133.
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to Day 120 An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect.
- Secondary Outcome Measures
Name Time Method Area under Concentration-Time Curve from Time 0 to Time t (AUC0-t) of BIIB133 Up to Day 120 Elimination Half-life (t½) of BIIB133 Up to Day 120 Percentage of AUCinf Obtained by Extrapolation (AUCextr%) of BIIB133 Up to Day 120 Maximum Observed Concentration (Cmax) of BIIB133 Up to Day 120 Clearance (CL) of BIIB133 Up to Day 120 Cmax/Dose of PEG Up to Day 120 Ratio of Cmax/Dose of BIIB133 between Japanese and Caucasian Participants Up to Day 120 Number of Participants with Anti-BIIB133 Antibodies Up to Day 120 Plasma Concentration of Anti-BIIB133 Antibodies Up to Day 120 Plasma BIIB133 Concentration Up to Day 120 Area under Concentration-Time Curve from Time 0 to Infinity (AUCinf) of BIIB133 Up to Day 120 Time to Reach Maximum Observed Concentration (Tmax) of BIIB133 Up to Day 120 Volume of Distribution (Vd) of BIIB133 Up to Day 120 Ratio of AUCinf of BIIB133 between Japanese and Caucasian Participants Up to Day 120 Area under Concentration-Time Curve from Time 0 to Infinity Normalized by Dose (AUCinf/Dose) of BIIB133 Up to Day 120 Cmax of PEG Up to Day 120 t½ of PEG Up to Day 120 AUC0-t/Dose of PEG Up to Day 120 Urine PEG Concentration Up to Day 120 Ratio of CL of BIIB133 between Japanese and Caucasian Participants Up to Day 120 Number of Participants with Anti-PEG Antibodies Up to Day 120 Area under Concentration-Time Curve from Time 0 to Time t Normalized by Dose (AUC0-t/Dose) of BIIB133 Up to Day 120 Maximum Observed Concentration Normalized by Dose (Cmax/Dose) of BIIB133 Up to Day 120 Plasma Polyethylene Glycol (PEG) Concentration Up to Day 120 AUCinf of PEG Up to Day 120 AUCextr% of PEG Up to Day 120 AUCinf/Dose of PEG Up to Day 120 Ratio of AUC0-t of BIIB133 between Japanese and Caucasian Participants Up to Day 120 Ratio of t½ of BIIB133 between Japanese and Caucasian Participants Up to Day 120 AUC0-t of PEG Up to Day 120 Tmax of PEG Up to Day 120 Ratio of AUCinf/Dose of BIIB133 between Japanese and Caucasian Participants Up to Day 120 Ratio of Cmax of BIIB133 between Japanese and Caucasian Participants Up to Day 120 Ratio of AUC0-t/Dose of BIIB133 between Japanese and Caucasian Participants Up to Day 120 Ratio of Vd of BIIB133 between Japanese and Caucasian Participants Up to Day 120 Plasma Concentration of Anti-PEG Antibodies Up to Day 120
Trial Locations
- Locations (1)
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States