Not Yet RecruitingPhase 1

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

China8 participantsStarted 2026-03-15

Plain-language summary

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

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Total radioactivity recovery and cumulative recovery in urine and feces in each time period;

Timeframe: 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);

Timeframe: DAY1~DAY60

Trial details

NCT IDNCT07460284

SponsorGuangdong Raynovent Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-14

Contact for this trial

Zhao, Professor

053189268311 qylcsyllwyh@163.com

View on ClinicalTrials.gov More Basic Science trials

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Total radioactivity recovery and cumulative recovery in urine and feces in each time period;

Timeframe: 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);

Timeframe: DAY1~DAY60