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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects
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
Lead sponsor
Asset
HRS9531
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
102
actual
Study population
Healthy volunteers
Key I/E criterion
—
Primary endpoint
•Treatment-emergent AEs (any)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (12)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChanges from baseline in Fasting Body Weight
Time frame:Run-in Period up to Day 113.
Body weight, absolute change (kg)
change from baseline, improvement
Total fat mass
Time frame:Run-in Period up to Day 113.
Total fat mass
descriptive, improvement
Glycemic / diabetes
3 endpointsChanges from baseline in Fasting Plasma Glucose
Time frame:Run-in Period up to Day 113.
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Changes from baseline in Fasting Insulin
Time frame:Run-in Period up to Day 113.
change from baseline, improvement
Changes from baseline in Fasting C-Peptide
Time frame:Run-in Period up to Day 113.
change from baseline, improvement
Safety / tolerability / PK
7 endpointsAdverse events (AEs)
Time frame:Screening period up to day 43.
Treatment-emergent AEs (any)
descriptive
The maximum plasma concentration (Cmax)
Time frame:Post-dose at day 1 to day 43.
Cmax
concentration, descriptive
Time to maximum plasma concentration (Tmax)
Time frame:Post-dose at day 1 to day 43.
Tmax
descriptive
Terminal half-life (t1/2)
Time frame:Post-dose at day 1 to day 43.
Half-life
descriptive
Apparent clearance (CL/F)
Time frame:Post-dose at day 1 to day 43.
descriptive
Apparent volume of distribution (Vz/F)
Time frame:Post-dose at day 1 to day 43.
descriptive
Anti-HRS-4729 antibodies
Time frame:Post-dose at day 1 to day 43.
Immunogenicity (ADA)
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.