Not yet recruiting NCT07460284

A Mass Balance Study Of 14C-RAY1225 Injection In Healthy Chinese Participants

Phase I Interventional Basic Science

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 14C-RAY1225.
Who it may be relevant to: Registry conditions: Basic Science. Basic parameters: 18 years — 55 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Mass Balance Study of 14C-RAY1225 Injection in Healthy Chinese Participants

This is an open-label, single-center, single-dose study.

Total radioactivity recovery and cumulative recovery in urine and feces in each time period; [Time frame: DAY1~DAY60]
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]

Secondary outcome measures (1)

Occurrence of adverse events/significant adverse events/serious adverse events [Time frame: DAY1~DAY60]

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;
Healthy adult males aged 18-55 years (inclusive, based on the time of signing the ICF);
Weight ≥ 50 kg, and body mass index (BMI) = weight (kg)/height2 (m 2) between 20.0-35.0 kg/m2 (inclusive);
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

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;
History of hypoglycemic episodes within 12 months prior to screening;
Major surgery or serious infection within 12 weeks prior to screening;
Acute disease from the signing of the ICF to the administration of the investigational drug;
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;
Participants who are not otherwise eligible to participate in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

China · 1 center

NCT: NCT07460284 · RAY1225-25-16