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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of BIIB122
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Cohort 1: Low-Dose
Participants will receive Dose 1 of BIIB122, orally, once on Day 1.
干预措施: BIIB122 (Drug)
Cohort 2: Mid-Dose
Participants will receive Dose 2 of BIIB122, orally, once on Day 1.
干预措施: BIIB122 (Drug)
Cohort 3: High-Dose
Participants will receive Dose 3 of BIIB122, orally, once on Day 1.
干预措施: BIIB122 (Drug)
Cohort 4: High-Multi-Dose
Participants will receive Dose 3 of BIIB122, orally, once daily (QD), for 10 days.
干预措施: BIIB122 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of BIIB122
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
Cohort 4: AR for Cmax
时间窗: Cohort 4: Pre-dose and at multiple time points post-dose on Days 10 to 13
次要结局
- 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)