Overweight or Obesity; Type 2 Diabetes
Conditions
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.
Interventions
DRUGHRS9531
Single dose escalation of HRS9531 tablets in healthy subjects
DRUGPlacebo
Single dose of placebo in healthy adults
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
randomized, double-blind, placebo-controlled
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to understand the trial procedures, be able and willing to provide a written informed consent. 2. 18-55 years of age at the time of signing informed consent. 3. 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. 4. Subjects with good general health, no clinically significant abnormalities.
Exclusion criteria
1. Known or suspected hypersensitivity to trial product(s) or related products. 2. 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. 3. Abnormal and clinically significant blood pressure at screening. 4. Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening. 5. Participation in other clinical trials. 6. Presence of any clinically significant results in examination at screening visit. 7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive. 8. Presence of - clinically significant ECG results. 9. Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive. 10. Addiction to tobacco and alcohol. 11. In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SAD Stage: Number of Adverse Events | 36 days |
| MAD Stage: Number of Adverse Events | 63 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration-Time to Peak (Tmax) of HRS9531 | 36 days | Tmax of a single dose of HRS9531 tablets |
| Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531 | 36 days | AUC of a single dose of HRS9531 tablets |
| Immunogenicity qualitative | 36 days | anti-HRS9531 antibody |
| Glucose | 35 days | fasting plasma glucose |
Countries
China
Outcome results
None listed