Overweight or Obesity
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.
Interventions
DRUGHRS-4729 injection
HRS-4729 injection
DRUGHRS-4729 injection placebo
HRS-4729 injection placebo
HRS9531 injection
HRS9531 injection placebo
DRUGAcetaminophen
Acetaminophen
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Voluntarily provides written informed consent prior to the initiation of any study-related activities and demonstrates understanding of the procedures and methods involved in the study, agreeing to adhere strictly to the clinical trial protocol to complete the study. 2. Male or female subjects; aged 18 to 55 years. 3. Self-reports no more than a 5 kg change in body weight during the 3 months prior to screening (including the screening visit).
Exclusion criteria
1. A history of current significant disease in the neurological, psychiatric, cardiovascular, gastrointestinal, respiratory, genitourinary, endocrine, hematologic, or immune systems, as determined by the investigator, which would render the subject unsuitable for participation in this trial. 2. A history of significant gastrointestinal disease or related symptoms, conditions affecting gastric emptying, or prior gastrointestinal surgery. 3. Subjects who have had a major surgery or severe trauma within 6 months prior to screening, or who are planned for surgical procedures during the trial period. 4. Participation in any drug or medical device clinical trial within 3 months prior to screening. 5. Any abnormal physical examination, vital signs, laboratory tests, chest X-ray and abdominal ultrasound findings deemed clinically significant by the investigator, rendering the subject unsuitable for participation. 6. Clinically significant abnormalities on 12-lead ECG as determined by the investigator. 7. Known or suspected history of drug abuse or substance dependence, or positive urine drug screen during the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | Screening period up to day 43. |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum plasma concentration (Tmax) | Post-dose at day 1 to day 43. |
| Terminal half-life (t1/2) | Post-dose at day 1 to day 43. |
| Apparent clearance (CL/F) | Post-dose at day 1 to day 43. |
| Apparent volume of distribution (Vz/F) | Post-dose at day 1 to day 43. |
| Anti-HRS-4729 antibodies | Post-dose at day 1 to day 43. |
| The maximum plasma concentration (Cmax) | Post-dose at day 1 to day 43. |
| Changes from baseline in Fasting Plasma Glucose | Run-in Period up to Day 113. |
| Changes from baseline in Fasting Insulin | Run-in Period up to Day 113. |
| Changes from baseline in Fasting C-Peptide | Run-in Period up to Day 113. |
| Total fat mass | Run-in Period up to Day 113. |
| Changes from baseline in Fasting Body Weight | Run-in Period up to Day 113. |
Countries
China
Contacts
Primary ContactPingan Yao
Backup ContactSheng Feng
Outcome results
None listed