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

April 14, 2023 updated by: Biogen

An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIIB122 in Healthy Adult Japanese, Chinese, and Caucasian Participants

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Key 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

Key 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1: Low-Dose
Participants will receive Dose 1 of BIIB122, orally, once on Day 1.
Drug: BIIB122
Administered as specified in the treatment arm.
Other Names:
  • DNL151
Experimental: Cohort 2: Mid-Dose
Participants will receive Dose 2 of BIIB122, orally, once on Day 1.
Drug: BIIB122
Administered as specified in the treatment arm.
Other Names:
  • DNL151
Experimental: Cohort 3: High-Dose
Participants will receive Dose 3 of BIIB122, orally, once on Day 1.
Drug: BIIB122
Administered as specified in the treatment arm.
Other Names:
  • DNL151
Experimental: Cohort 4: High-Multi-Dose
Participants will receive Dose 3 of BIIB122, orally, once daily (QD), for 10 days.
Drug: BIIB122
Administered as specified in the treatment arm.
Other Names:
  • DNL151

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax) of BIIB122
Time Frame: 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: 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
Time Frame: 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: 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
Time Frame: 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: 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
Time Frame: 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: 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
Time Frame: 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: 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)
Time Frame: Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
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)
Time Frame: Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
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)
Time Frame: Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
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)
Time Frame: Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
Cohort 4: AR for Cmax
Time Frame: Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Cohorts 1,2 and 3: Up to Day 10; Cohort 4: Up to Day 20
An AE is any untoward medical occurrence in a participant or clinical investigation participant (healthy volunteer) 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 (including an abnormal laboratory finding), 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, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
Cohorts 1,2 and 3: Up to Day 10; Cohort 4: Up to Day 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 283HV101

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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