A Mass Balance Study Of 14C-RAY1225 Injection In Healthy Chinese Participants
ConditionBasic Science
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGuangdong Raynovent Biotech Co., Ltd
About this trial
This is an open-label, single-center, single-dose study.
Eligibility criteria
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- 14C-RAY1225
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov