A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.
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
- 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
- •Signed and dated written informed consent obtained before undertaking any trial-specific procedures.
- •Be within the age range of 18 to 55 years, inclusive, at the time of screening.
- •Have a body mass index (BMI) ≥18.5 and ≤30.0 kg/m^2.
排除标准
- •History and/or physical examination evidence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, immunological, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk for taking part in the trial, influence the results of the trial, influence the participant's ability to take part in the trial.
- •Any medication (including vaccines, over the counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal participants) for 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first administration of trial drug (except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks).
- •History of chronic drug or alcohol abuse (defined as an average intake of more than 21 units of alcohol per week for males and 14 for females. 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) in the last 2 years.
研究组 & 干预措施
Part 2: Multiple ascending dose (MAD)
Participants will receive multiple oral doses of Debio 1453P or placebo from Day 1 to Day 5. Debio 1453P initial dose in this part will be based on available data from SAD part.
干预措施: Debio 1453P (Drug)
Part 1: Single ascending dose (SAD)
Participants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1.
干预措施: Debio 1453P (Drug)
Part 1: Single ascending dose (SAD)
Participants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1.
干预措施: Placebo (Drug)
Part 2: Multiple ascending dose (MAD)
Participants will receive multiple oral doses of Debio 1453P or placebo from Day 1 to Day 5. Debio 1453P initial dose in this part will be based on available data from SAD part.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 15 months
次要结局
- Plasma Concentration of Debio 1453P(Pre-dose and at multiple timepoints post-dose up to Day 12)
- Urine Concentration of Debio 1453P(Pre-dose and at multiple timepoints post-dose up to Day 12)