A Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Part A: Safety and Tolerability
研究概览
简要总结
This Study is a Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects.
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
- Triple (Participant, 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
- •Female and male adults, ages ≥ 18 and ≤ 65 years.
- •Part A: Healthy subjects with body mass index (BMI) ≥ 20.0 kg/m2 and ≤ 27 kg/m
- •Part B: Obese subjects with BMI ≥ 30.0 kg/m2 and ≤ 45.0 kg/m2 with a stable body weight for 3 months prior to screening (defined as change < 5%).
- •HbA1c < 6.5 % [based on American Diabetes Association, 2023].
- •Female subjects must be non-pregnant and non-lactating.
- •Subjects must be able to provide written informed consent and are willing to follow study procedures and commitment to the study duration.
排除标准
- •Subject with existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product.
- •Active or untreated malignancy or has been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for < 5 years.
- •Subjects with a history of any serious adverse reaction or hypersensitivity to study drug components (includes GLP-1, GIP, glucagon analogs) or have contraindicating diseases.
- •Subjects with confirmed type 1 or type 2 diabetes.
- •Subject is unwilling to avoid consumption of coffee and caffeine-containing beverages within from 24 hours before each study visit and while subjects are confined to the study center.
- •Subject is unwilling to abstain from vigorous exercise from 48 hours prior to admission until the Follow-up visit.
- •History of alcohol abuse as judged by the Investigator within approximately 1 year prior to Screening.
- •History of regular use (defined as ≥ 10 cigarettes per day) of nicotine-containing products (including but not limited to cigarettes, e-cigarettes, pipe, chewing tobacco, nicotine patch or gum) or vaping products within 6 weeks prior to check-in for the first In-house Period.
研究组 & 干预措施
HM15275
Active comparator:
Part A: single-ascending dose
Single doses of HM15275 in healthy adults administered via subcutaneous injection.
Part B: multiple-ascending dose
Multiple doses of HM15275 in obese adults administered via subcutaneous injection.
干预措施: HM15275 (Drug)
HM15275
Active comparator:
Part A: single-ascending dose
Single doses of HM15275 in healthy adults administered via subcutaneous injection.
Part B: multiple-ascending dose
Multiple doses of HM15275 in obese adults administered via subcutaneous injection.
干预措施: Placebo of HM15275 (Drug)
Placebo of HM15275
Placebo comparator:
Part A: single-ascending dose
Single doses of HM15275 placebo in healthy adults administered via subcutaneous injection.
Part B: multiple-ascending dose
Multiple doses of HM15275 placebo in obese adults administered via subcutaneous injection.
干预措施: HM15275 (Drug)
Placebo of HM15275
Placebo comparator:
Part A: single-ascending dose
Single doses of HM15275 placebo in healthy adults administered via subcutaneous injection.
Part B: multiple-ascending dose
Multiple doses of HM15275 placebo in obese adults administered via subcutaneous injection.
干预措施: Placebo of HM15275 (Drug)
结局指标
主要结局
Part A: Safety and Tolerability
时间窗: Up to Day 29
Number of participants with treatment-emergent adverse events (TEAEs) after a single subcutaneous dose
Part B: Safety and Tolerability
时间窗: Up to Day 57
Number of participants with treatment-emergent adverse events (TEAEs) after multiple subcutaneous doses
次要结局
- Part A: Pharmacokinetics(Up to Day 29)
- Part B: Pharmacokinetics(Up to Day 57)