NCT07535099招募中1 期
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ICP-538 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
- 104
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily sign the ICF..
- •BMI between 18-26 kg/m² (inclusive). Male weight ≥50 kg; female weight ≥45 kg.
- •Vital signs, physical examination, ECG, Chest X-ray, Abdominal ultrasound results at screening are within normal range or showing minor deviations deemed not clinically significant by the investigator.
- •Laboratory test results at screening and baseline are within the normal reference range.
- •Reproductive Status：Females of non-childbearing potential . Male participants and their partners must agree to use effective contraception throughout the study and for 3 months after the last dose. Male participants must not donate sperm during this period.
排除标准
- •Evidence or history of clinically significant diseases, or Evidence or history of allergic diseases .
- •Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption.
- •Acute illness within 14 days before dosing.
- •Severe infection within 6 months before dosing, or chronic/recurrent infections.
- •Participant and/or first-degree relative with hereditary immunodeficiency.
- •Major trauma or surgery within 3 months before dosing.
- •History of active/latent TB or contact with an open TB case within 6 months before dosing.
- •Positive urine drug screen.
- •Alcohol abuse.
- •Use of tobacco/nicotine products within 3 months before the first dose.
- •Use of any prescription/non-prescription drugs, herbal medicines, supplements within 14 days before first dose; or systemic corticosteroids, immunosuppressants/modulators, hormone replacement therapy within 30 days before first dose; or any other factor affecting drug absorption, distribution, metabolism, and excretion.
- •Consumption of caffeine-containing foods/beverages within 48 hours before the first dose.
- •Use of known CYP3A4 inducers/inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose.
- •Dieting, dietary therapy within 30 days before the first dose.
- •Positive for syphilis antibody, HCV-Ab, HBsAg, HBcAb, or HIV-Ab at screening.
- •Administration of live vaccines within 6 weeks before the first dose or planned during study or within 8 weeks after study.
研究组 & 干预措施
Single ascending doses of placebo
Placebo Comparator
干预措施: ICP-538 placebo Tablets (Drug)
Multiple ascending doses of placebo
Placebo Comparator
干预措施: ICP-538 placebo Tablets (Drug)
Single ascending doses of ICP-538 tablet
Experimental
干预措施: ICP-538 Tablets (Drug)
Multiple ascending doses of ICP-538 tablet
Experimental
干预措施: ICP-538 Tablets (Drug)
结局指标
主要结局
Treatment-emergent adverse events (TEAEs)
时间窗: Up to 7 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs).
The incidence and severity of abnormal clinical laboratory tests
时间窗: Up to 7 weeks
Incidence and severity of clinically significant laboratory test abnormalities during treatment (including hematology, biochemistry, urinalysis, stool routine, etc.).
The incidence of abnormalities in vital signs, physical examination, 12-lead ECG, etc.
时间窗: up to 7 weeks
The incidence of abnormalities in vital signs, physical examination, 12-lead ECG, etc.
次要结局
未报告次要终点
研究者
研究点 (1)
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