This is an open-label, single-center, single-dose study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Total radioactivity recovery and cumulative recovery in urine and feces in each time period; — DAY1~DAY60 To quantitatively analyze the total radioactivity in the excretions of healthy participants after subcutaneous injection of 14C-RAY1225, and to obtain the primary radioactivity recovery data and primary excretion pathways in humans;
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); — DAY1~DAY60
Trial sites (1)
Facility
City
Region
Status
Shandong Provincial Qianfoshan Hospital
Jinan
Shandong
More Guangdong Raynovent Biotech Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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