A Randomized, Placebo-controlled, Single-Ascending Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Severity of treatment emergent adverse events as measured by CTCAE v 5.0
研究概览
简要总结
Huahui Health is developing a treatment for Hepatitis B virus. This study is designed to evaluate the safety and tolerability of HH-006, a hepatitis virus neutralizing monoclonal antibody in healthy volunteers, and to determine its pharmacokinetic profile and immunogenicity.
详细描述
This is a double-blind, placebo-controlled, Phase Ia study aimed to evaluate the safety and tolerability of HH-006 after single ascending doses given as subcutaneous injections.
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
- Double (Participant, Investigator)
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
- •Generally healthy male or female individuals aged between 18 to 65 years old
- •A bodyweight ≥ 45 kg and the body mass index (BMI) is between 18 to 32 kg/m2.
排除标准
- •History of anaphylaxis or other significant allergy in the opinion of the Investigator or known allergy or hypersensitivity to any of the components of the IP
- •History of drug, alcohol, or substance abuse
- •Any history of liver disease or known hepatic, or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- •Any history of anaphylaxis, severe allergic reaction, neutralizing antibody generations, or hypersensitivity to albumin or any protein-based therapeutics such as natalizumab (Tysabri) or any other monoclonal antibodies
- •Any previous exposure to chimeric, humanized, or human monoclonal antibody, whether licensed or not
- •Medical history of active infection (acute or chronic)
- •Any safety concern or personal condition that is inappropriate for the study participation per the Investigator's judgement.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
HH-006
干预措施: HH-006 (Drug)
结局指标
主要结局
Severity of treatment emergent adverse events as measured by CTCAE v 5.0
时间窗: Day 1- Day 113
Duration of treatment emergent adverse events
时间窗: Day 1- Day 113
Number of participants with treatment emergent adverse events (TEAEs)
时间窗: Day 1- Day 113
An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
次要结局
- Tmax(Day 1-Day 113)
- Cmax(Day 1-Day 113)
- AUC0-inf(Day 1- Day 113)
- Vz/F (SAD)(Day 1-Day 113)
- Titres of anti drug antibodies (ADA) to HH-006(Day 1- Day 113)
- t1/2(Day 1- Day 113)
- CL (SAD)(Day 1-Day 113)
- AUC0- last(Day 1-Day 113)
- CL/F (SAD)(Day 1-Day 113)