NCT05638347已完成1 期
Use the Protocol Title. A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect on the Pharmacokinetics of HRS-7085 in Healthy Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of HRS-7085.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
- •Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- •Total body weight 45 kg~100 kg (inclusive) at screening, and body mass index (BMI) between 18 and 32 kg/m2 (inclusive).
- •For healthy subjects, no clinically significant abnormalities.
- •Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
排除标准
- •Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
- •Severe injuries or major surgeries within 3 months before dosing.
- •Subjects with infectious disease.
- •Live/attenuated vaccine within 3 months prior to dosing or any vaccine during the trial.
- •Blood donation or loss of ≥ 200 mL of blood within 1 month prior to dosing, or ≥ 400 mL of blood within 3 months prior to dosing; or receive a blood transfusion within 2 months prior to dosing.
- •Clinically significant abnormalities in 12-Lead ECG
- •More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening, or positive cotinine test at screening or baseline.
- •Positive urine drug at screening or baseline.
- •Subject who cannot perform venous blood sampling.
- •Known history or suspected of being allergic to the study drugs and their excipients.
- •Use of prescription medicine within 2 weeks, or OTC medicine, within 1-week or 5 half-lives prior to dosing.
- •History of alcohol abuse within 3 months prior to screening, or positive alcohol breath test at screening or baseline.
- •Participation in clinical trials of other investigational drugs or medical devices within 1 month or 5 half-lives prior to dosing.
- •Special dietary requirements that cannot follow the meal plan in the food effect study.
- •In the investigator's judgment, may increase the risk to the subject.
- •Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.
研究组 & 干预措施
HRS-7085 tablets Cohort 1
Experimental
Part 1- HRS-7085 tablets
干预措施: HRS-7085 tablets (Drug)
HRS-7085 tablets Cohort 1
Experimental
Part 1- HRS-7085 tablets
干预措施: Placebo tablet (Drug)
HRS-7085 tablets Cohort 6
Experimental
Part 1- HRS-7085 tablets
干预措施: HRS-7085 tablets (Drug)
HRS-7085 tablets Cohort 6
Experimental
Part 1- HRS-7085 tablets
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: Start of Treatment to end of study approximately 1 week
次要结局
- Pharmacokinetics-AUC0-last(Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-AUC0-inf(Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-CL/F(Time Frame: Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-t1/2(Time Frame: Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-Tmax(Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-Vz/F(Time Frame: Start of Treatment to end of study (approximately 1 week))
- Pharmacokinetics-Cmax(Time Frame: Start of Treatment to end of study (approximately 1 week))
研究者
研究点 (1)
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