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CompletedPhase 1

A Clinical Study of Mass Balance of [14C]HRS-7535

A Clinical Study of Mass Balance of [14C]HRS-7535 in Healthy Adult Chinese Subjects

Asset

KAI-7535 / HRS-7535

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

6

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 19-26MaleHealthy volunteers

Primary endpoints

Time of Cmax (Tmax)CmaxTerminal 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 IDNCT06819488
Org study IDHRS-7535-106

Timeline

Milestones

Study first posted2025-02-11actual
Study start2025-02-27actual
Primary completion2025-04-16actual
Study completion2025-04-16actual
Last update posted2025-05-07actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

1. Subjects must voluntarily sign the informed consent form (ICF) prior to any activities related to the study, demonstrate understanding of the study procedures and methods, and commit to strictly adhering to the clinical trial protocol to complete the study.

2. Healthy male subjects aged between 18 and 45 years (inclusive), determined at the time of signing the informed consent.

3. Male subjects must weigh ≥ 50 kg and have a body mass index (BMI) between 19 and 26 kg/m² (inclusive).

4. Male subjects with female partners of childbearing potential must have no plans for procreation or sperm donation from the time of signing the informed consent until one year after the last dose of the study drug. They must also agree to use highly effective contraception methods (including their partners) during this period.

Exclusion criteria

1. Subjects with abnormalities identified through a comprehensive physical examination, vital signs assessment, laboratory tests, chest X-ray, 12-lead ECG, or abdominal ultrasound that are deemed clinically significant by the investigator.

2. Subjects with QTcF ≥ 450 msec at screening or baseline, or any other abnormalities considered clinically significant by the investigator.

3. Subjects who test positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antigen/antibody combination, or syphilis-specific antibodies.

4. Subjects with a history of drug abuse, drug dependence (based on medical history), or those who test positive for drug abuse during urine screening prior to dosing.

5. Subjects who have used any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements within 2 weeks prior to screening.

Endpoints (8)

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.

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

The time of maximum observed concentration (Tmax)

Time frame:0-120 hours.

concentration, descriptive

Primary/protocol endpoint

The maximum observed concentration (Cmax)

Time frame:0-120 hours.

concentration, descriptive

Primary/protocol endpoint

The terminal half-life (t1/2)

Time frame:0-120 hours.

concentration, descriptive

Primary/protocol endpoint

The total body clearance for extravascular administration (CL/F)

Time frame:0-120 hours.

concentration, descriptive

Primary/protocol endpoint

The total radioactivity ratio for blood

Time frame:0-96 hours.

ratio, event

Primary/protocol endpoint

The total radioactivity ratio for plasma

Time frame:0-96 hours.

concentration, descriptive

Secondary/protocol endpoint

Adverse events (AEs)

Time frame:0-11 days.

descriptive

Secondary/protocol endpoint

Serious adverse events (AEs)

Time frame:0-11 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.