NCT06536101已完成1 期
A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GIM-407 in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evaluation of Safety
研究概览
简要总结
This study is for the evaluation of the safety, tolerability, PK, PD, and biomarker activity of GIM-407 in healthy volunteers in the absence of any disease-related or potentially confounding factors.
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
- •Healthy male or female subjects (non childbearing or agree to use appropriate effective birth control),
- •Nonsmoker or occasional smoker (ie, who smokes ≤10 cigarettes or equivalent of tobacco or nicotine-containing products, including vapes) per week within 30 days prior to Screening and is able to abide by the smoking policy of the study site during the in house observation period.
排除标准
- •History or presence of any disease that affects drug absorption, distribution, metabolism, or excretion such as gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, cholecystectomy, etc
- •Any current active infections, including localized infections, or any recent history of active infections, cough, or fever within 1 week prior to study drug
- •Known history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
- •Use of any prescribed or nonprescribed medication (including over-the-counter medications, vitamins, multivitamins, recreational drugs, dietary supplements, and herbal remedies such as St. John's Wort extract) or drugs considered likely to interfere with the safe conduct of the study within 7 days or 5 half lives of the drug (whichever is longer) prior to the first dose
- •Receipt of an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational intervention (drug, vaccine, or invasive medical device)
- •Have received any live vaccines (bacterial or viral) within 30 days prior to the first dose of IP or intend to receive a live vaccine during the study period.
- •Pregnant or breastfeeding female participant. Female participant who is planning to become pregnant or planning to discontinue contraceptive precautions.
研究组 & 干预措施
GIM-407 oral dose
Experimental
SAD: Up to 5 ascending cohorts of subjects are planned to be orally dosed
MAD: Up to 4 ascending dose cohorts of subjects are planned to be orally dosed once daily for 7 consecutive days
干预措施: GIM-407 (Drug)
Matching placebo oral dose
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of Safety
时间窗: Baseline through Study Completion (up to Day 14)
Number of participants with abnormal physical examination findings as assessed by the investigator
次要结局
- Area Under the Curve (AUC) will be assessed(Multiple timepoints from Baseline through Study Completion (up to Day 14))
- Maximum Blood Concentration (Cmax) will be assessed(Multiple timepoints from Baseline through Study Completion (up to Day 14))
研究者
研究点 (1)
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