NCT07808918尚未招募1 期
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1597 Tablets Following Single-Dose Administration in Healthy Participants and Multiple-Dose Administration in Obese Participants, and the Effect of Food on the Pharmacokinetics of HRS-1597 Tablets
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2026年9月1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
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Safety: incidence of adverse event (AE), serious adverse event (SAE)
研究概览
简要总结
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of HRS-1597 tablets following single-dose administration in healthy participants and multiple-dose administration in obese participants, as well as the effect of food on the pharmacokinetics of HRS-1597 tablets.
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
- •Aged 18 to 55 years (inclusive), both male and female.
- •Part 1 (SAD + FE): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 19-26 kg/m² (inclusive).
- •Part 2 (MAD): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 28-35 kg/m² (inclusive).
- •Male and female participants of childbearing potential and their partners agree to have no plans for pregnancy or sperm/egg donation within 6 months (for female participants) or 3 months (for male participants) after the last dose, and voluntarily agree to use highly effective contraceptive measures. Female participants of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose (baseline period), and must not be lactating.
排除标准
- •General Conditions:
- •Smoking more than 5 cigarettes (or other nicotine-containing products) per day within 3 months prior to screening, or planning to use any tobacco products during the study period.
- •History of needle phobia or blood phobia, poor venous access, difficulty in blood collection, or inability to tolerate venipuncture.
- •Clinically significant abnormalities in physical examination, vital signs, laboratory tests (including complete blood count, urinalysis, blood biochemistry, and coagulation function), chest imaging, abdominal ultrasound, or 12-lead electrocardiogram (ECG), as judged by the investigator.
- •Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), syphilis antibody, or human immunodeficiency virus (HIV) antibody.
- •History of Any of the Following Diseases or Conditions:
- •Suspected allergy to the investigational product or any of its components, or a history of severe allergy to any drug, food, toxin, or other exposure.
- •History of liver disease.
- •History of diabetes or pre-diabetes.
- •Diagnosis of malignancy or history of malignant tumors.
- •History of any clinically significant disease or condition that, in the investigator's opinion, may affect the study results, including but not limited to disorders of the circulatory, endocrine, neurological, digestive, urinary, hematopoietic, immune, psychiatric, or metabolic systems; or any condition that may affect the study results, drug absorption, distribution, metabolism, or excretion, or place the participant at undue risk.
- •Current or Prior Use of the Following Medications:
- •Use of any prescription drugs, over-the-counter drugs (including natural health products, with the exception of routine vitamins), herbal medicines, or live (attenuated) vaccines within 1 month or 5 half-lives of the drug (whichever is longer) prior to baseline.
- •Refusal to abstain from any beverages or foods containing methylxanthines (e.g., coffee, tea, cola, chocolate, etc.) from 48 hours prior to baseline through the end of the study; refusal to abstain from any beverages or foods containing grapefruit from 7 days prior to baseline through the end of the study; or special dietary requirements that prevent compliance with a standardized diet.
研究组 & 干预措施
multiple ascending dose (MAD) cohorts
Experimental
Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-1597 or placebo
干预措施: HRS-1597 (Drug)
multiple ascending dose (MAD) cohorts
Experimental
Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-1597 or placebo
干预措施: Placebo (Drug)
single ascending dose (SAD) cohorts
Experimental
Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-1597 or placebo
干预措施: HRS-1597 (Drug)
single ascending dose (SAD) cohorts
Experimental
Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-1597 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: incidence of adverse event (AE), serious adverse event (SAE)
时间窗: 10 days (SAD), 41 days (MAD)
次要结局
- PK parameters of HRS-1597 in plasma and urine : Cmax(Days 1-34)
- PK parameters of HRS-1597 in plasma and urine : Tmax(Days 1-34)
- PK parameters of HRS-1597 in plasma and urine : AUC(Days 1-34)
- PK parameters of HRS-1597 in plasma and urine : CL/F(Days 1-34)
- PK parameters of HRS-1597 in plasma and urine : CLR(Days 1-34)
- PK parameters of HRS-1597 in plasma and urine : Vz/F(Days 1-34)
- PD endpoint (Fasting blood glucose)of HRS-1597(Baseline-Day 34)
- PD endpoint (Fasting serum insulin)of HRS-1597(Baseline-Day 34)
- PD endpoint (Fasting C-peptide)of HRS-1597(Baseline-Day 34)
- PD endpoint (HOMA-IR)of HRS-1597(Baseline-Day 34)
研究者
研究点 (1)
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