Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Dapirolizumab Pegol (BIIB133) in Healthy Japanese and Caucasian Study Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The primary objective of the study is to assess the safety and tolerability of a single intravenous (IV) dose of dapirolizumab pegol (DZP) in Japanese healthy study participants compared with those of Caucasian healthy study participants.
The secondary objectives of the study are to assess the pharmacokinetic(s) (PK) of a single IV dose of DZP in Japanese and Caucasian healthy study participants, to evaluate ethnic sensitivity on the PK of DZP between body weight- and gender-matched Japanese and Caucasian healthy study participants and to evaluate the immunogenicity of a single IV dose of DZP in Japanese and Caucasian healthy study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 14 days of Day -1 (inclusive).
- •Japanese study participant has both biological parents and all 4 grandparents of Japanese descent and, if living outside of Japan for more than 5 years, must maintain a Japanese diet.
- •Caucasian study participant has both biological parents and all 4 grandparents of Caucasian descent.
- •Have a body weight between 50 and 90 kilograms (kg) (inclusive) and body mass index (BMI) between 18.0 and 26.0 kilograms per meter square (kg/m^2) (inclusive) at the Screening Visit.
排除标准
- •History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- •Have undergone major surgery in the last 6 months or plans to undergo elective major surgery during the study period.
- •Have a known hypersensitivity to any components or excipients of DZP including polyethylene glycol (PEG).
- •Have received any prescription or nonprescription medicines including over-the-counter remedies and herbal and dietary supplements within 14 days or 5 half-lives of the respective drug, whichever is longer, other than acetaminophen and antihistamines.
- •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.
- •History of chronic, recurrent, or recent (within 6 months prior to Screening) severe infection and/or at risk for severe infection, as determined by the Investigator.
- •Have symptoms consistent with SARS-CoV-2 infection, per the judgement of the Investigator, within 14 days prior to Day -1, including but not limited to fever (temperature > 37.5 degree Celsius [°C]), sore throat, new and persistent cough, breathlessness, or loss of taste or smell.
- •Have close contact within 14 days prior to Day -1 with a SARS-CoV-2 (+) individual. Close contact is defined as (1) being within 6 feet of an infected individual (as confirmed via laboratory assessment) for at least 15 minutes within 2 days of symptom onset or (2) being within 6 feet of an asymptomatic infected individual for at least 15 minutes within 2 days of that asymptomatic individual undergoing specimen collection for SARS-CoV-2 testing.
- •Clinically significant abnormal laboratory test result values, as determined by the Investigator, at Screening or Day -
- •Have received any live/attenuated vaccination within 6 weeks prior to Visit 2 (Day 1) or plans to receive any live/attenuated vaccination within 120 days after the dose of study treatment.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort 1: BIIB133 Dose 1
Participants will receive single IV infusion of BIIB133 Dose 1.
干预措施: BIIB133 (Dapirolizumab pegol) (Drug)
Cohort 2: BIIB133 Dose 2
Participants will receive single IV infusion of BIIB133 Dose 2.
干预措施: BIIB133 (Dapirolizumab pegol) (Drug)
Cohort 1-2: Placebo
Participants will receive single IV infusion of matching placebo to BIIB133.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to Day 120
An AE is any untoward medical occurrence in a participant 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, 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, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect.
次要结局
- Area under Concentration-Time Curve from Time 0 to Time t (AUC0-t) of BIIB133(Up to Day 120)
- Elimination Half-life (t½) of BIIB133(Up to Day 120)
- Percentage of AUCinf Obtained by Extrapolation (AUCextr%) of BIIB133(Up to Day 120)
- Maximum Observed Concentration (Cmax) of BIIB133(Up to Day 120)
- Clearance (CL) of BIIB133(Up to Day 120)
- Cmax/Dose of PEG(Up to Day 120)
- Ratio of Cmax/Dose of BIIB133 between Japanese and Caucasian Participants(Up to Day 120)
- Number of Participants with Anti-BIIB133 Antibodies(Up to Day 120)
- Plasma Concentration of Anti-BIIB133 Antibodies(Up to Day 120)
- Plasma BIIB133 Concentration(Up to Day 120)
- Area under Concentration-Time Curve from Time 0 to Infinity (AUCinf) of BIIB133(Up to Day 120)
- Time to Reach Maximum Observed Concentration (Tmax) of BIIB133(Up to Day 120)
- Volume of Distribution (Vd) of BIIB133(Up to Day 120)
- Ratio of AUCinf of BIIB133 between Japanese and Caucasian Participants(Up to Day 120)
- Area under Concentration-Time Curve from Time 0 to Infinity Normalized by Dose (AUCinf/Dose) of BIIB133(Up to Day 120)
- Cmax of PEG(Up to Day 120)
- t½ of PEG(Up to Day 120)
- AUC0-t/Dose of PEG(Up to Day 120)
- Urine PEG Concentration(Up to Day 120)
- Ratio of CL of BIIB133 between Japanese and Caucasian Participants(Up to Day 120)
- Number of Participants with Anti-PEG Antibodies(Up to Day 120)
- Area under Concentration-Time Curve from Time 0 to Time t Normalized by Dose (AUC0-t/Dose) of BIIB133(Up to Day 120)
- Maximum Observed Concentration Normalized by Dose (Cmax/Dose) of BIIB133(Up to Day 120)
- Plasma Polyethylene Glycol (PEG) Concentration(Up to Day 120)
- AUCinf of PEG(Up to Day 120)
- AUCextr% of PEG(Up to Day 120)
- AUCinf/Dose of PEG(Up to Day 120)
- Ratio of AUC0-t of BIIB133 between Japanese and Caucasian Participants(Up to Day 120)
- Ratio of t½ of BIIB133 between Japanese and Caucasian Participants(Up to Day 120)
- AUC0-t of PEG(Up to Day 120)
- Tmax of PEG(Up to Day 120)
- Ratio of AUCinf/Dose of BIIB133 between Japanese and Caucasian Participants(Up to Day 120)
- Ratio of Cmax of BIIB133 between Japanese and Caucasian Participants(Up to Day 120)
- Ratio of AUC0-t/Dose of BIIB133 between Japanese and Caucasian Participants(Up to Day 120)
- Ratio of Vd of BIIB133 between Japanese and Caucasian Participants(Up to Day 120)
- Plasma Concentration of Anti-PEG Antibodies(Up to Day 120)