A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants

Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Dapirolizumab Pegol (BIIB133) in Healthy Japanese and Caucasian Study Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: BIIB133 (Dapirolizumab pegol)

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials

Participation Criteria

Eligibility Criteria

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

Description

Key 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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: BIIB133 Dose 1; Participants will receive single IV infusion of BIIB133 Dose 1.	Drug: BIIB133 (Dapirolizumab pegol); Administered as specified in the treatment arm; Other Names: DZP
Experimental: Cohort 2: BIIB133 Dose 2; Participants will receive single IV infusion of BIIB133 Dose 2.	Drug: BIIB133 (Dapirolizumab pegol); Administered as specified in the treatment arm; Other Names: DZP
Placebo Comparator: Cohort 1-2: Placebo; Participants will receive single IV infusion of matching placebo to BIIB133.	Drug: Placebo; Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Up to Day 120

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma BIIB133 Concentration	Up to Day 120
Area under Concentration-Time Curve from Time 0 to Infinity (AUCinf) of BIIB133	Up to Day 120
Area under Concentration-Time Curve from Time 0 to Time t (AUC0-t) of BIIB133	Up to Day 120
Maximum Observed Concentration (Cmax) of BIIB133	Up to Day 120
Time to Reach Maximum Observed Concentration (Tmax) of BIIB133	Up to Day 120
Elimination Half-life (t½) of BIIB133	Up to Day 120
Clearance (CL) of BIIB133	Up to Day 120
Volume of Distribution (Vd) of BIIB133	Up to Day 120
Percentage of AUCinf Obtained by Extrapolation (AUCextr%) of BIIB133	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
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
AUC0-t of PEG	Up to Day 120
Cmax of PEG	Up to Day 120
Tmax of PEG	Up to Day 120
t½ of PEG	Up to Day 120
AUCextr% of PEG	Up to Day 120
AUCinf/Dose of PEG	Up to Day 120
AUC0-t/Dose of PEG	Up to Day 120
Cmax/Dose of PEG	Up to Day 120
Urine PEG Concentration	Up to Day 120
Ratio of AUCinf of BIIB133 between Japanese and Caucasian Participants	Up to Day 120
Ratio of AUC0-t 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 t½ of BIIB133 between Japanese and Caucasian Participants	Up to Day 120
Ratio of CL 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
Ratio of AUCinf/Dose 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 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
Number of Participants with Anti-PEG Antibodies	Up to Day 120
Plasma Concentration of Anti-PEG Antibodies	Up to Day 120

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): April 8, 2021
• Study Completion (Actual): April 8, 2021

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 253HV101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

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