A Study to See How BIIB122 Works in the Human Body, and t... | NCT05229562

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BIIB122	Drug	Administered as specified in the treatment arm.	Cohort 1: Low-Dose Cohort 2: Mid-Dose Cohort 3: High-Dose Cohort 4: High-Multi-Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.

Eligibility Module

Eligibility Criteria

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.