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CompletedPhase 1

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

Asset

HRS9531

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

7

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 19-32.5MaleHealthy volunteers

Primary endpoints

CmaxReach 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

NCT IDNCT06855147
Org study IDHRS9531-109

Timeline

Milestones

Study first posted2025-03-03actual
Study start2025-04-21actual
Primary completion2025-06-17actual
Study completion2025-06-17actual
Last update posted2025-07-04actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexMale
Healthy volunteersAccepted

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
Other (unclassified)
1

Safety / tolerability / PK

10 endpoints
Primary/protocol endpoint

Maximum concentration (Cmax).

Time frame:0 to anticipated 64 days.

Cmax

concentration, descriptive

Primary/protocol endpoint

Time to reach the maximum concentration (Tmax).

Time frame:0 to anticipated 64 days.

Tmax

descriptive

Primary/protocol endpoint

Half-life (t1/2).

Time frame:0 to anticipated 64 days.

Half-life

descriptive

Primary/protocol endpoint

Total radioactive recovery rate in urine.

Time frame:0 to anticipated 64 days.

descriptive

Primary/protocol endpoint

Total radioactive recovery rate in feces.

Time frame:0 to anticipated 64 days.

descriptive

Primary/protocol endpoint

Cumulative radioactive recovery rate in urine.

Time frame:0 to anticipated 64 days.

descriptive

Secondary/protocol endpoint

Whole blood total radioactivity (TRA) ratio.

Time frame:0 to anticipated 64 days.

ratio, descriptive

Secondary/protocol endpoint

Plasma total radioactivity (TRA) ratio.

Time frame:0 to anticipated 64 days.

ratio, descriptive

Secondary/protocol endpoint

Adverse events (AEs).

Time frame:0 to 7 days after the last sample collection.

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Serious adverse events (SAEs).

Time frame:0 to 7 days after the last sample collection.

Serious AEs (any)

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Cumulative radioactive recovery rate in feces.

Time frame:0 to anticipated 64 days.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.