Basic Science
Conditions
Brief summary
This is an open-label, single-center, single-dose study.
Interventions
DRUG14C-RAY1225
subcutaneous injection
Sponsors
Guangdong Raynovent Biotech Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events/significant adverse events/serious adverse events | DAY1~DAY60 |
Countries
China
Contacts
CONTACTZhao, Professor
Outcome results
None listed