NCT06780254已完成1 期
A Two-Part Randomized Double-Blinded Placebo-Controlled, Phase 1 Study of Single and Multiple Ascending Doses of MH-001 in Healthy Participants
Vespina Lifesciences Inc.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年9月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Percentage of participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
First-in-Human study to demonstrate the safety and tolerability of single- and multiple-ascending doses of MH-001 in Healthy Volunteers (HVs)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-childbearing potential Female, non smoker, with a Body Mass Index (BMI) between 18.5 and 32.0 kilogram per meter square (kg/m2) and red blood cells greater or equal (≥) to 120 grams per liter (g/L) for women and ≥135 g/L for men
- •In good health, determined by no clinically significant findings of skin, dental, neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease
排除标准
- •Have a history or presence of clinically significant medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, chronic or relevant acute infections, relevant immunodeficiency, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality that, in the judgment of the Investigator, indicates a medical problem that would preclude study participation.
- •History of skin disorders including clinically significant active skin disease.
- •History/signs and symptoms of current or recurrent teeth and gums disease
- •Clinically significant abnormal laboratory test results or positive hepatitis panel and/or positive human immunodeficiency virus test.
研究组 & 干预措施
MH-001
Experimental
In each cohort, 6/8 participants will be exposed to 1 or multiple administrations of a specific dosage of MH-001
干预措施: MH-001 (Drug)
Placebo
Placebo Comparator
In each cohort, 2/8 participants will be exposed to 1 or multiple administrations of a placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants with treatment-emergent adverse events (TEAEs)
时间窗: SAD: From day of dosing until 15 days after drug administration; MAD: From first day of dosing up to 28 days after the last day (Day 28) of study drug administration
Percentage of participants with treatment-emergent adverse events (TEAEs)
次要结局
- Time to reach Peak Concentration (Tmax) of the analyte in plasma(SAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 15; MAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 56)
- Area under the concentration-time curve (AUC) of the analyte in plasma over time(SAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 15; MAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 56)
- Peak Plasma Concentration (Cmax) of the analyte in plasma(SAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 15; MAD: Pre-dose and at multiple timepoints post-dose on Days 1 to 56)
研究者
研究点 (1)
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