Clinical trial NCT06762600: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects
Official title: A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of HRS-4729 Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Overweight or Obesity
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Screening period up to day 43.
Secondary outcomes:
measure: The maximum plasma concentration (Cmax)
timeFrame: Post-dose at day 1 to day 43.
measure: Time to maximum plasma concentration (Tmax)
timeFrame: Post-dose at day 1 to day 43.
measure: Terminal half-life (t1/2)
timeFrame: Post-dose at day 1 to day 43.
measure: Apparent clearance (CL/F)
timeFrame: Post-dose at day 1 to day 43.
measure: Apparent volume of distribution (Vz/F)
timeFrame: Post-dose at day 1 to day 43.
measure: Anti-HRS-4729 antibodies
timeFrame: Post-dose at day 1 to day 43.
measure: Changes from baseline in Fasting Body Weight
timeFrame: Run-in Period up to Day 113.
measure: Changes from baseline in Fasting Plasma Glucose
timeFrame: Run-in Period up to Day 113.
measure: Changes from baseline in Fasting Insulin
timeFrame: Run-in Period up to Day 113.
measure: Changes from baseline in Fasting C-Peptide
timeFrame: Run-in Period up to Day 113.
measure: Total fat mass
timeFrame: Run-in Period up to Day 113.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
Study officials:
References: