An Open-Label Parallel-Dose Study of the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Japanese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concentrations of pozelimab in serum over time
研究概览
简要总结
The primary objective of the study is to assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart.
The secondary objectives of the study are:
- To evaluate the safety and tolerability of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants
- To assess the pharmacodynamic (PD) profile of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants
- To assess the immunogenicity of pozelimab and cemdisiran in healthy Japanese adult participants
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese participant must be:
- •Be Japanese, born in Japan, and have both biologic parents and 4 biologic grandparents who are ethnically Japanese and born in Japan
- •Have maintained a Japanese lifestyle, with no significant change since leaving Japan, including having access to Japanese food and adhering to a Japanese diet
- •Living < 10 years outside of Japan
- •Has a Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) at screening visit
- •Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECGs performed at screening and/or prior to administration of initial dose of study drug
- •Is in good health based on laboratory safety testing obtained at the screening visit Note: Participant with suspected or confirmed Gilbert's disease can be enrolled in the study
- •Willing to undergo vaccination against N. meningitidis unless participant has documentation of completed series of vaccinations within the past 2 years of the screening visit
- •Must have two consecutive negative COVID-19 tests at least 48 hours apart and within 7 days prior to study drug administration Note: The test may be the point of care quantitative reverse transcriptase polymerase chain reaction (RT-qPCR) test or approved COVID-19 antigen test at the discretion of the investigator.
排除标准
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator as defined in the protocol
- •Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
- •Hospitalization (>24 hour) for any reason within 30 days of the screening visit
- •Has a confirmed positive drug test result at the screening visit and/or prior to enrollment; or a history of alcohol and/or drug abuse within a year prior to the screening visit
- •Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at the screening visit
- •Is positive for hepatitis C antibody and positive for qualitative (i.e., detected) hepatitis C virus (HCV) RNA test at the screening visit
- •Within the previous 2 months of the screening visit has a history of bacterial, protozoal, viral or parasite infection (including COVID-19) and/or persistent chronic or active recurring infection which require treatment with antibiotics, antivirals, or antifungals
- •Known or suspected COVID-19 disease at screening and/or prior to 1st dose administration
- •NOTE: Other protocol-defined Inclusion and Exclusion criteria apply
研究组 & 干预措施
Cohort 1
Pozelimab: Single-dose SC on day 1
干预措施: Pozelimab (Drug)
Cohort 2
Pozelimab: Single-dose IV on day 1
干预措施: Pozelimab (Drug)
Cohort 3
Pozelimab: Single-dose SC on day 29 Cemdisiran: Single-dose SC on day 1
干预措施: Pozelimab (Drug)
Cohort 3
Pozelimab: Single-dose SC on day 29 Cemdisiran: Single-dose SC on day 1
干预措施: Cemdisiran (Drug)
Cohort 4
Pozelimab: Single-dose SC on day 1 Cemdisiran: Single-dose SC on day 1
干预措施: Pozelimab (Drug)
Cohort 4
Pozelimab: Single-dose SC on day 1 Cemdisiran: Single-dose SC on day 1
干预措施: Cemdisiran (Drug)
Cohort 5
Optional Pozelimab: Single-dose SC on day 1 or day 29 Cemdisiran: Single-dose SC on day 1
干预措施: Pozelimab (Drug)
Cohort 5
Optional Pozelimab: Single-dose SC on day 1 or day 29 Cemdisiran: Single-dose SC on day 1
干预措施: Cemdisiran (Drug)
Cohort 6
Pozelimab: Single-dose IV on day 1
干预措施: Pozelimab (Drug)
结局指标
主要结局
Concentrations of pozelimab in serum over time
时间窗: Up to 20 weeks
Concentrations of cemdisiran in plasma over time.
时间窗: Up to 20 weeks
次要结局
- Concentrations of total C5 in plasma over time(Up to 20 weeks)
- The incidence and severity of treatment-emergent adverse events (TEAE) in subjects administered pozelimab with/without cemdisiran(Up to 20 weeks)
- Change from baseline in CH50 over time(Up to 20 weeks)
- Incidence of treatment-emergent anti-drug antibodies (ADA) to pozelimab(Up to 20 weeks)
- Incidence of treatment-emergent ADA to cemdisiran(Up to 20 weeks)