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A Mass Balance Study Of 14C-RAY1225 Injection In Healthy Chinese Participants
A Mass Balance Study of 14C-RAY1225 Injection in Healthy Chinese Participants
Lead sponsor
Asset
RAY1225
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
8
estimated
Study population
Healthy volunteers
Key I/E criteria
•BMI 20-35•Healthy volunteers
Primary endpoints
•Total radioactivity recovery and cumulative recovery in urine•Radioactivity of each metabolite in urine
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. Participants who sign the informed consent form, fully understand the content, process, and possible adverse reactions of the study, and are able to complete the study as required by the study protocol;
2. Healthy adult males aged 18-55 years (inclusive, based on the time of signing the ICF);
3. Weight ≥ 50 kg, and body mass index (BMI) = weight (kg)/height2 (m 2) between 20.0-35.0 kg/m2 (inclusive);
4. Participants (including partners) who agree to voluntarily use effective contraception from screening until 6 months after the investigational drug administration and have no sperm donation plan. For specific contraceptive measures
Exclusion criteria
1. Subjects with trauma, surgical scar, or skin lesions at the proposed administration site (abdomen) who are not suitable for subcutaneous injection as assessed by the investigator;
2. History of hypoglycemic episodes within 12 months prior to screening;
3. Major surgery or serious infection within 12 weeks prior to screening;
4. Acute disease from the signing of the ICF to the administration of the investigational drug;
5. Smoking more than 5 cigarettes per day within 12 weeks prior to screening, or unable to abstain from smoking within 7 days prior to admission and during the study;
6. Participants who are not otherwise eligible to participate in this study.
Endpoints (3)
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
3 endpointsTotal radioactivity recovery and cumulative recovery in urine and feces in each time period;
Time frame:DAY1~DAY60
descriptive
Radioactivity of each metabolite in urine and feces as a percentage of the total administered dose and the circulating metabolites in plasma as a percentage of the total exposure AUC (%AUC);
Time frame:DAY1~DAY60
concentration, descriptive
Occurrence of adverse events/significant adverse events/serious adverse events
Time frame:DAY1~DAY60
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.