A Study to See How BIIB122 Works in the Human Body, and to Evaluate it's Safety, and Tolerability in Healthy Adult Japanese, Chinese, and Caucasian Participants

NCT ID: NCT05229562

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2022-09-07

Brief Summary

The study will be looking at an investigational drug, BIIB122, in healthy adult Japanese, Chinese, and Caucasian participants. The main goal of the study is to compare the drug level achieved in the body, between the different ethnic groups, after single and multiple doses of BIIB122. Researchers also want to see if single and multiple doses of BIIB122 are safe and if healthy participants can tolerate given doses of BIIB122.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Low-Dose

Participants will receive Dose 1 of BIIB122, orally, once on Day 1.

Group Type: EXPERIMENTAL

BIIB122

Intervention Type: DRUG

Administered as specified in the treatment arm.

Cohort 2: Mid-Dose

Participants will receive Dose 2 of BIIB122, orally, once on Day 1.

Group Type: EXPERIMENTAL

BIIB122

Intervention Type: DRUG

Administered as specified in the treatment arm.

Cohort 3: High-Dose

Participants will receive Dose 3 of BIIB122, orally, once on Day 1.

Group Type: EXPERIMENTAL

BIIB122

Intervention Type: DRUG

Administered as specified in the treatment arm.

Cohort 4: High-Multi-Dose

Participants will receive Dose 3 of BIIB122, orally, once daily (QD), for 10 days.

Group Type: EXPERIMENTAL

BIIB122

Intervention Type: DRUG

Administered as specified in the treatment arm.

Interventions

BIIB122

Administered as specified in the treatment arm.

Intervention Type: DRUG

Other Intervention Names

DNL151

Eligibility Criteria

Inclusion Criteria

• Have a body mass index (BMI) between 18 and 30 kilograms per square meter (kg/m^2), inclusive. Body weight (BW) ≥50 kg and ≤100 kg at Screening
• Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening and Day -1
• For Japanese healthy volunteers: Participant was born in Japan, and biological parents and grandparents were of Japanese origin; if living outside of Japan for more than 10 years, must not have significantly modified diet since leaving Japan
• For Chinese healthy volunteers: Participant was born in China, and biological parents and grandparents were of Chinese origin; if living outside of China for more than 5 years, must not have had a significantly modified diet since leaving China. Additionally, Chinese healthy volunteers must be of the same gender and have a screening weight within ±15% of their matched Caucasian healthy volunteer
• For Caucasian healthy volunteers: Participant must be a white person of European descent, which may include participants of Hispanic descent. Additionally, Caucasian healthy volunteers must be of the same gender and have a screening weight within ±15% of their matched Japanese healthy volunteer

Exclusion Criteria

• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator
• History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment
• 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
• Immunization or vaccinations are not allowed from Screening to safety follow-up (SFU)/ early termination (ET) Visit

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Countries

United States

Other Identifiers

283HV101

Identifier Type: -

Identifier Source: org_study_id