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

NCT04571424 | Completed Phase 1 FDA Drug

• 1 other identifier: 253HV101
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (36)

• 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

Study Arms (3)

Cohort 1: BIIB133 Dose 1

EXPERIMENTAL

Participants will receive single IV infusion of BIIB133 Dose 1.

Drug: BIIB133 (Dapirolizumab pegol)

Cohort 2: BIIB133 Dose 2

EXPERIMENTAL

Participants will receive single IV infusion of BIIB133 Dose 2.

Drug: BIIB133 (Dapirolizumab pegol)

Cohort 1-2: Placebo

PLACEBO COMPARATOR

Participants will receive single IV infusion of matching placebo to BIIB133.

Drug: Placebo

Interventions

BIIB133 (Dapirolizumab pegol) DRUG

Administered as specified in the treatment arm

Also known as: DZP

Cohort 1: BIIB133 Dose 1; Cohort 2: BIIB133 Dose 2

Placebo DRUG

Administered as specified in the treatment arm

Cohort 1-2: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

MeSH Terms

Interventions

dapirolizumab pegol

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

• Amina Haggag, M.D

  Anaheim Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 1, 2020
• Study Start: October 14, 2020
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)