NCT07841860尚未招募1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets as a Single Dose in Healthy Participants and Multiple Doses in Obese Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- The incidence and severity of adverse events (AEs)
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese participants.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily sign the informed consent form before the commencement of the activities related to this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.
- •The age range is from 18 to 55 years old (inclusive at both ends).
- •Weight ≥ 50.0 kg.
- •They must also not be in the lactation period. For male participants whose partners are fertile women, they must agree to voluntarily adopt medically approved highly effective contraceptive measures from the time of signing the informed consent form until 2 months after the last administration. They must have no intention to have children and must avoid donating sperm/eggs (including their partners).
排除标准
- •During the screening process, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg were considered.
- •The score of the Patient Health Questionnaire-9 (PHQ-9) during screening was ≥ 15 points.
- •During the screening process, there may be cases where there are obvious endocrine diseases or medical histories that could significantly affect body weight (such as Cushing's syndrome, hypothyroidism or hyperthyroidism, etc.), or obesity caused by single gene mutations or hereditary obesity syndromes, etc.
- •Diabetes (except gestational diabetes).
- •Any malignant tumor of any organ system has occurred within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis (except for cured local basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ).
- •Those who have had or currently have the following diseases with clinical significance (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cardiovascular diseases), and who, in the judgment of the investigators, are not suitable to participate in this trial.
- •Those who consumed more than 14 units of alcohol per week within the previous 6 months (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol content spirits or 150 mL of wine); or those who had taken any alcohol-containing products within 48 hours before the administration; or those with a positive alcohol breath test result.
- •Screening criteria: Daily smoking quantity greater than 5 cigarettes within the past 3 months or use of any tobacco product within 48 hours prior to administration.
- •Those with a known or suspected history of drug abuse or drug use; or those with a positive urine drug screening result.
- •Unable to tolerate venipuncture for blood collection or experiencing fainting or nausea during the procedure.
研究组 & 干预措施
HRS-1596 Group
Experimental
HRS-1596, healthy subjects or obese subjects.
干预措施: HRS-1596 (Drug)
HRS-1596 Placebo Group
Placebo Comparator
HRS-1596 placebo, healthy subjects or obese subjects.
干预措施: HRS-1596 Placebo (Drug)
结局指标
主要结局
The incidence and severity of adverse events (AEs)
时间窗: Screening period up to Day 84.
次要结局
- Terminal half-life (t1/2)(Post-dose at Day 1 to Day 84.)
- The maximum plasma concentration (Cmax)(Post-dose at Day 1 to Day 84.)
- Time to maximum plasma concentration (Tmax)(Post-dose at Day 1 to Day 84.)
- Anti-HRS-1596 Antibodies (ADAs)(Post-dose at Day 1 to Day 84.)
- Fasting plasma glucose (FPG)(Post-dose at Day 1 to Day 84.)
研究者
研究点 (1)
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