A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of 611 in Adult Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Participants With TEAEs
研究概览
简要总结
This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.
详细描述
Total duration of the study period per subject is about 4 months broken down as follows:
The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Able to understand and willing to sign the ICF
- •Healthy male and female subjects, non-smokers, 18-55 years of age
- •In the opinion of the investigator, with no significant medical history, and in good health.
- •Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- •Subjects are able to follow the study protocol and complete the trial.
排除标准
- •History of hypersensitivity to similar drugs to 611 or their excipients.
- •Pregnant, or nursing females.
- •HepBsAg or HepCAb positive.
- •Human immunodeficiency virus (HIV) positive.
- •Positive urine drug screen, or cotinine test.
- •Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
Cohort 1
611 dose 1 (45mg) plus placebo
干预措施: Placebo (Drug)
Cohort 1
611 dose 1 (45mg) plus placebo
干预措施: 611 (Drug)
Cohort 2
611 dose 2 (150mg) plus placebo
干预措施: Placebo (Drug)
Cohort 2
611 dose 2 (150mg) plus placebo
干预措施: 611 (Drug)
Cohort 3
611 dose 3 (300mg) plus placebo
干预措施: Placebo (Drug)
Cohort 3
611 dose 3 (300mg) plus placebo
干预措施: 611 (Drug)
Cohort 4
611 dose 4 (450mg) plus placebo
干预措施: Placebo (Drug)
Cohort 4
611 dose 4 (450mg) plus placebo
干预措施: 611 (Drug)
Cohort 5
611 dose 5 (600mg) plus placebo
干预措施: Placebo (Drug)
Cohort 5
611 dose 5 (600mg) plus placebo
干预措施: 611 (Drug)
结局指标
主要结局
Percentage of Participants With TEAEs
时间窗: up to 71days (90 days for Cohorts 1 and 2)
Incidence of treatment-emergent adverse events (TEAEs) will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.
次要结局
- Incidence of immunogenicity(up to 71days (90 days for Cohorts 1 and 2))
- PK(up to 71days (90 days for Cohorts 1 and 2))