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

NCT05229562 | Completed Phase 1 FDA Drug

• 1 other identifier: 283HV101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• Maximum Observed Plasma Concentration (Cmax) of BIIB122

  Cohorts 1,2 and 3: At multiple time points post-dose on Days 1 to 4, and at Day 10; Cohort 4: At multiple time points post-dose on Day 1, Pre-dose on Days 2 to 9, Pre-dose and at multiple time points post-dose on Days 10 to 13, and at Day 20

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of BIIB122

  Cohorts 1,2 and 3: At multiple time points post-dose on Days 1 to 4, and at Day 10; Cohort 4: At multiple time points post-dose on Day 1, Pre-dose on Days 2 to 9, Pre-dose and at multiple time points post-dose on Days 10 to 13, and at Day 20

• Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of BIIB122

  Cohorts 1,2 and 3: At multiple time points post-dose on Days 1 to 4, and at Day 10; Cohort 4: At multiple time points post-dose on Day 1, Pre-dose on Days 2 to 9, Pre-dose and at multiple time points post-dose on Days 10 to 13, and at Day 20

• Cohorts 1,2 and 3: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of BIIB122

  Cohorts 1,2 and 3: At multiple time points post-dose on Days 1 to 4, and at Day 10

• Cohorts 1,2 and 3: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of BIIB122

  Cohorts 1, 2 and 3: At multiple time points post-dose on Days 1 to 4, and at Day 10

• Cohort 4: Cmax of BIIB122 at Steady State (Cmax,ss)

  Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13

• Cohort 4: Tmax of BIIB122 at Steady State (Tmax,ss)

  Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13

• Cohort 4: AUC of BIIB122 Within a Dosing Interval at Steady State (AUCtau,ss)

  Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13

• Cohort 4: Accumulation Ratio (AR) for AUC Within a Dosing Interval (AUCtau)

  Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13

• Cohort 4: AR for Cmax

  Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Cohorts 1,2 and 3: Up to Day 10; Cohort 4: Up to Day 20

Study Arms (4)

Cohort 1: Low-Dose

EXPERIMENTAL

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

Drug: BIIB122

Cohort 2: Mid-Dose

EXPERIMENTAL

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

Drug: BIIB122

Cohort 3: High-Dose

EXPERIMENTAL

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

Drug: BIIB122

Cohort 4: High-Multi-Dose

EXPERIMENTAL

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

Drug: BIIB122

Interventions

BIIB122 DRUG

Administered as specified in the treatment arm.

Also known as: DNL151

Cohort 1: Low-Dose; Cohort 2: Mid-Dose; Cohort 3: High-Dose; Cohort 4: High-Multi-Dose

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

MeSH Terms

Interventions

DNL151

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 8, 2022
• Study Start: February 17, 2022
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)