NCT06435676
Completed
Phase 1
A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of HRS9531 Tablets in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- HRS9531
- Conditions
- Overweight or Obesity; Type 2 Diabetes
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- MAD Stage: Number of Adverse Events
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS9531tablets in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to understand the trial procedures, be able and willing to provide a written informed consent.
- •18-55 years of age at the time of signing informed consent.
- •SAD stage: Body weight ≥50 kg,19.0 ≤BMI≤ 35.0 kg/m2 at screening visit. MAD stage: 24.0 ≤BMI≤ 35.0 kg/m2 at screening visit.
- •Subjects with good general health, no clinically significant abnormalities.
Exclusion Criteria
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
- •Abnormal and clinically significant blood pressure at screening.
- •Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
- •Participation in other clinical trials.
- •Presence of any clinically significant results in examination at screening visit.
- •Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
- •Presence of - clinically significant ECG results.
- •Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
- •Addiction to tobacco and alcohol.
Arms & Interventions
SAD Stage: HRS9531
Administered po once
Intervention: HRS9531
SAD Stage: placebo
Administered po once
Intervention: Placebo
MAD Stage: HRS9531
Administered po for multiple dose
Intervention: HRS9531
MAD Stage: placebo
Administered po for multiple dose
Intervention: Placebo
Outcomes
Primary Outcomes
MAD Stage: Number of Adverse Events
Time Frame: 63 days
SAD Stage: Number of Adverse Events
Time Frame: 36 days
Secondary Outcomes
- Immunogenicity qualitative(63 days)
- Plasma Concentration-Time to Peak (Tmax) of HRS9531(63 days)
- Glucose(35 days)
- Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531(63 days)
Study Sites (1)
Loading locations...
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