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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
Lead sponsor
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 19-26•Male•Healthy volunteers
Primary endpoints
•Time of Cmax (Tmax)•Cmax•Terminal 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. 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 endpointsThe time of maximum observed concentration (Tmax)
Time frame:0-120 hours.
concentration, descriptive
The maximum observed concentration (Cmax)
Time frame:0-120 hours.
concentration, descriptive
The terminal half-life (t1/2)
Time frame:0-120 hours.
concentration, descriptive
The total body clearance for extravascular administration (CL/F)
Time frame:0-120 hours.
concentration, descriptive
The total radioactivity ratio for blood
Time frame:0-96 hours.
ratio, event
The total radioactivity ratio for plasma
Time frame:0-96 hours.
concentration, descriptive
Adverse events (AEs)
Time frame:0-11 days.
descriptive
Serious adverse events (AEs)
Time frame:0-11 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.