A Phase 1, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
研究概览
简要总结
A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects
详细描述
This is the first time HEC88473 will be administered to humans. The aim of this study is to obtain safety, tolerability, PK, PD, and immunogenicity data of HEC88473 SC administration as single and multiple ascending doses in healthy 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, of any race, between 18 and 60 years of age, inclusive, at screening.
- •Body weight ≥ 50 kg, and body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at screening as assessed by the investigator (or designee).
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- •History of alcoholism or drug/chemical abuse within 2 years prior to the first dosing.
- •Alcohol consumption of > 21 units per week for males and > 14 units per week for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- •Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening and/or check-in.
- •Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to the first dosing or planned vaccination during the course of the study.
- •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to the first dosing.
- •Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dosing, unless deemed acceptable by the investigator (or designee).
研究组 & 干预措施
Single dose of 0.5 mg HEC88473
Healthy subjects, receiving a single dose of 0.5 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: HEC88473 injection (Drug)
Single dose of 0.5 mg HEC88473
Healthy subjects, receiving a single dose of 0.5 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: Placebo (Drug)
Single dose of 1.7 mg HEC88473
Healthy subjects, receiving a single dose of 1.7 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: HEC88473 injection (Drug)
Single dose of 1.7 mg HEC88473
Healthy subjects, receiving a single dose of 1.7 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: Placebo (Drug)
Single dose of 5.1 mg HEC88473
Healthy subjects, receiving a single dose of 5.1 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: HEC88473 injection (Drug)
Single dose of 5.1 mg HEC88473
Healthy subjects, receiving a single dose of 5.1 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: Placebo (Drug)
Single dose of 10.2 mg HEC88473
Healthy subjects, receiving a single dose of 10.2 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: HEC88473 injection (Drug)
Single dose of 10.2 mg HEC88473
Healthy subjects, receiving a single dose of 10.2 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: Placebo (Drug)
Single dose of 17.0 mg HEC88473
Healthy subjects, receiving a single dose of 17.0 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: HEC88473 injection (Drug)
Single dose of 17.0 mg HEC88473
Healthy subjects, receiving a single dose of 17.0 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: Placebo (Drug)
Single dose of 25.5 mg HEC88473
Healthy subjects, receiving a single dose of 25.5 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: HEC88473 injection (Drug)
Single dose of 25.5 mg HEC88473
Healthy subjects, receiving a single dose of 25.5 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: Placebo (Drug)
Single dose of 34.0 mg HEC88473
Healthy subjects, receiving a single dose of 34.0 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: HEC88473 injection (Drug)
Single dose of 34.0 mg HEC88473
Healthy subjects, receiving a single dose of 34.0 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: Placebo (Drug)
Single dose of 44.2 mg HEC88473
Healthy subjects, receiving a single dose of 44.2 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: HEC88473 injection (Drug)
Single dose of 44.2 mg HEC88473
Healthy subjects, receiving a single dose of 44.2 mg HEC88473 (N=6) or placebo(N=2) after meal.
干预措施: Placebo (Drug)
Multiple doses of 1.7 mg HEC88473
Healthy subjects, receiving a weekly dose of 1.7 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
干预措施: HEC88473 injection (Drug)
Multiple doses of 1.7 mg HEC88473
Healthy subjects, receiving a weekly dose of 1.7 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
干预措施: Placebo (Drug)
Multiple doses of 5.1 mg HEC88473
Healthy subjects, receiving a weekly dose of 5.1 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
干预措施: HEC88473 injection (Drug)
Multiple doses of 5.1 mg HEC88473
Healthy subjects, receiving a weekly dose of 5.1 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
干预措施: Placebo (Drug)
Multiple doses of 10.2 mg HEC88473
Healthy subjects, receiving a weekly dose of 10.2 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
干预措施: HEC88473 injection (Drug)
Multiple doses of 10.2 mg HEC88473
Healthy subjects, receiving a weekly dose of 10.2 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
时间窗: Baseline to day 15
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473
时间窗: Baseline to day 43
AUC
时间窗: Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
Area under the plasma concentration-time curve (AUC)
Cmax
时间窗: Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
Maximum observed plasma concentration of HEC88473
次要结局
- OGTT(Predose and postdose 2, 4 hours)
- Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing(Baseline to day 43)