A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug
研究概览
简要总结
This study includes two parts (Single Ascending Dose, SAD; Multiple-Ascending Dose, MAD) and enrolls healthy participants. Participants in SAD accept single subcutaneous (SC) injection of HS-20094 and participants in MAD accept SC injection of HS-20094 once weekly for 4 weeks. The main purpose of this study is to determine 1) The safety of HS-20094; 2) How much HS-20094 gets into the bloodstream and how long it takes the body to get rid of it.3) How HS-20094 affects the levels of blood sugar, insulin and weight.
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
- Double (Participant, Investigator)
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
- •Screening weight of male ≥50 kg, female≥45 kg and 19≤BMI≤28
- •Subjects agree to use an effective method of contraception and avoid sperm or egg donation for the duration of the study and for 6 months following the last dose of investigational product
- •Agree to avoid alcohol, foods and beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) from 48 hours prior to administration to last visit, and to avoid strenuous exercise
排除标准
- •Pregnant or lactating women
- •Subjects have a medical history of cardiovascular, respiratory, liver, kidney, digestive tract, mental, neurological, hematology or metabolic abnormalities (e.g., repeated hypoglycemia for unknown reasons) and are judged not suitable for this study by the investigator.
- •Subjects with abnormal screening vital signs, physical examination, laboratory examination or 12 lead electrocardiogram results with clinical significance
- •Have a history of drug allergy, or known allergies to HS-20094, glucagon-like peptide (GLP)-1 analogs, or glucose-dependent insulinotropic polypeptide (GIP) receptor agonism
- •Received systemic steroid therapy, immunomodulator therapy or chemotherapy in the 3 months prior to screening, or are likely to receive these treatments during the study period
- •Have a history of digestive disease (e.g., gastroesophageal reflux disease, gallbladder disease, or chronic enteritis) that may affect gastrointestinal adverse events assessment or any other gastrointestinal disease (e.g., gastric bypass surgery, pyloric stenosis, etc.) that may affect gastric emptying
- •Have a diet, weight loss treatment or significant lifestyle changes prior to 30 days of administration
研究组 & 干预措施
HS-20094 (Single dose)
Escalating doses of HS-20094 administered subcutaneously (SC) once in healthy participants.
干预措施: HS-20094 (Drug)
HS-20094 (Multiple doses)
Escalating doses of HS-20094 administered SC once weekly for four weeks in healthy participants.
干预措施: HS-20094 (Drug)
Placebo (Single dose)
Placebo administered SC once in healthy participants.
干预措施: Placebo (Drug)
Placebo (Multiple doses)
Placebo administered SC once weekly for four weeks in healthy participants.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug
时间窗: Time of Inform Consent Form to Day 29 (SAD) or Day 50 (MAD)
A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module
次要结局
- Pharmacodynamics (PD): AUC of glucose(Day 22 (MAD))
- Pharmacodynamics (PD): AUC of insulin(Day 22 (MAD))
- Pharmacokinetics (PK): Cmax of HS-20094(Baseline to Day 22 (SAD) or Day 43 (MAD))
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094(Baseline to Day 22 (SAD) or Day 43 (MAD))
- Pharmacokinetics (PK): Tmax of HS-20094(Baseline to Day 22 (SAD) or Day 43 (MAD))
- Weight change(baseline to Day 29 (SAD) or Day 50 (MAD))