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Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects
A Single-center, Open-label, Phase Ⅰ Clinical Study of the Absorption, Metabolism, and Excretion of [14C]HRS9531 in Healthy Male Subjects
Lead sponsor
Asset
HRS9531
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
7
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI 19-32.5•Male•Healthy volunteers
Primary endpoints
•Cmax•Reach the Cmax (Tmax)•Half-life (t1/2)
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. Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content and potential adverse reactions.
2. Healthy male subjects aged between 18 and 55 years (inclusive), determined at the time of signing the informed consent.
3. Body weight ≥50 kg, and the body mass index (BMI) between 19 to 32.5 kg/m2.
4. From the signing of the informed consent form until 12 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan.
Exclusion criteria
1. History of any clinically important disease or disorder.
2. History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug.
3. Physical examination, vital signs or other laboratory measurements, other electrocardiographic parameters, abdominal ultrasound (except mild fatty liver), and abnormalities on chest radiography as judged by the investigator to be clinically significant.
4. The subject was considered by the investigator to have any other factors that would preclude him from participating in the study or the subject withdrew from the study due to his own reasons.
Endpoints (11)
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
Safety / tolerability / PK
10 endpointsMaximum concentration (Cmax).
Time frame:0 to anticipated 64 days.
Cmax
concentration, descriptive
Time to reach the maximum concentration (Tmax).
Time frame:0 to anticipated 64 days.
Tmax
descriptive
Half-life (t1/2).
Time frame:0 to anticipated 64 days.
Half-life
descriptive
Total radioactive recovery rate in urine.
Time frame:0 to anticipated 64 days.
descriptive
Total radioactive recovery rate in feces.
Time frame:0 to anticipated 64 days.
descriptive
Cumulative radioactive recovery rate in urine.
Time frame:0 to anticipated 64 days.
descriptive
Whole blood total radioactivity (TRA) ratio.
Time frame:0 to anticipated 64 days.
ratio, descriptive
Plasma total radioactivity (TRA) ratio.
Time frame:0 to anticipated 64 days.
ratio, descriptive
Adverse events (AEs).
Time frame:0 to 7 days after the last sample collection.
Treatment-emergent AEs (any)
event count, event
Serious adverse events (SAEs).
Time frame:0 to 7 days after the last sample collection.
Serious AEs (any)
event count, event
Other (unclassified)
1 endpointCumulative radioactive recovery rate in feces.
Time frame:0 to anticipated 64 days.
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.