Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of HBM9161(HL161BKN) in Healthy Chinese Volunteers (Randomized, Single-blinded, Placebo-controlled Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The number [N (%)] of subjects with drug-related AEs
研究概览
简要总结
Trial Objective: To investigate the safety, tolerability, PK, and PD following single ascending doses of HBM9161 in healthy Chinese subjects.
详细描述
HBM9161(HL161BKN) is a human monoclonal antibody. HBM9161 targets the neonatal Fc receptor (FcRn) . The neonatal FcRn is a potential therapeutic target for many autoimmune diseases. This Phase I study will evaluate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of HBM9161(HL161BKN) (abbreviated as HBM9161) in healthy Chinese subjects. Up to 24 healthy Chinese subjects will be randomized into the study. For each dose group, 8 subjects will be randomized (6 subjects to HBM9161 group and 2 subjects to placebo group).
This study will also provide guidance on doses to be used in future studies involving patients with autoimmune diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Han Chinese male or female subjects, and his/her biological parents and grandparents are of Han Chinese ethnicity.
- •Body weight ≥ 50kg with BMI ≥19.0 and <=24.0 kg/m2 at screening and baseline visit.
- •Generally, in good health with no clinically significant abnormalities as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests.
排除标准
- •Subject has a total IgG level of < 700mg/dL at screening.
- •Subject has an active infection or has had a serious infection within 6 weeks prior to Day -1 or infection requiring oral anti-infective agents within 2 weeks prior to Day-1, or subject had a febrile illness or symptomatic, viral, bacterial, or fungal infection within 1 week prior to admission (Day -1).
- •History of relevant allergy/hypersensitivity (including allergy to study drug or its excipients).
- •Any laboratory values outside the reference range that are of clinical significance according to investigator's clinical judgement.
- •Subject has estimated creatinine clearance ≤ 80 mL/min calculated by Cockcroft Gault formula at screening.
- •Subject has any ECG abnormality defined in the protocol (a single repeat will be allowed for eligibility determination) at screening or Day -1:
- •Positive HIV test result at screening.
- •Positive testing for HBs Antigen and/or a positive Hepatitis C antibody test result at screening.
- •Subject has a positive T-cell interferon-γ release assay (TIGRA) result
- •Subjects who had immunization within 4 weeks before screening; or subjects who plan to have immunization during the study and within 12 weeks after dosing of the study drug.
- •For female subjects, positive pregnancy test at screening or Day -1, or planning to become pregnant from screening until 90 days after the dosing of the study drug.
- •Lactating female subjects.
研究组 & 干预措施
HBM9161 340mg
干预措施: HBM9161(HL161BKN) (Drug)
HBM9161 510mg
干预措施: HBM9161(HL161BKN) (Drug)
HBM9161 680mg
干预措施: HBM9161(HL161BKN) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The number [N (%)] of subjects with drug-related AEs
时间窗: 85 days
The number \[N (%)\] of subjects with drug-related AEs
次要结局
未报告次要终点