NCT07686484招募中1 期
A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-3095 in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants
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
- 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
- •Main inclusion criteria
- •Healthy white participants.
- •Male or female aged between 18 years and 55 years (inclusive)
- •Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
- •Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
- •Men and WOCBP must agree to take highly effective contraceptive methods
排除标准
- •History or evidence of clinically significant disorders.
- •Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study drug or same class drug or any component of it.
- •Receipt of medical devices or another investigational drug within 3 months or 5 half-lives, whichever is longer prior to screening.
- •History of excessive smoking in the past 1 month prior to screening
- •History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
- •Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
HRS-3095 single dose Dose level 2
Experimental
Single dose HRS-3095 /placebo given orally
干预措施: HRS-3095 (Drug)
HRS-3095 single dose Dose level 3
Experimental
Single dose HRS-3095 /placebo given orally
干预措施: HRS-3095 (Drug)
HRS-3095 single dose Dose level 1
Experimental
Single dose HRS-3095 /placebo given orally
干预措施: HRS-3095 (Drug)
结局指标
主要结局
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
时间窗: Day 8
Number of participants with Adverse events and Serious adverse events
次要结局
- PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Cmax(Day 4)
- PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - AU0-inf(Day 4)
- PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Tmax(Day 4)
- PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - t½(Day 4)
- PD Profile of HRS-3095 After a Single dose administration:(Day 8)
研究者
研究点 (2)
Loading locations...
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