Clinical trial NCT06435676: A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects
Official title: A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of HRS9531 Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight or Obesity; Type 2 Diabetes
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: SAD Stage: Number of Adverse Events
timeFrame: 36 days
measure: MAD Stage: Number of Adverse Events
timeFrame: 63 days
Secondary outcomes:
measure: Plasma Concentration-Time to Peak (Tmax) of HRS9531
timeFrame: 36 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531
timeFrame: 36 days
measure: Immunogenicity qualitative
timeFrame: 36 days
measure: Plasma Concentration-Time to Peak (Tmax) of HRS9531
timeFrame: 63 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531
timeFrame: 63 days
measure: Glucose
timeFrame: 35 days
measure: Immunogenicity qualitative
timeFrame: 63 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital Of Anhui medical University
state: Anhui
Study officials:
References: