Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects

Fujian Shengdi Pharmaceutical

Status and phase

Not yet enrolling

Phase 1

Conditions

Weight Loss

Type 2 Diabetes Mellitus

Treatments

Drug: [14C]HRS9531

Study type

Interventional

Funder types

Industry

Identifiers

NCT06855147

HRS9531-109

Details and patient eligibility

About

This study was a single-center, single-dose, open-label study in healthy male subjects to investigate the absorption, metabolism and excretion of HRS9531 after a single subcutaneous injection of [14C]HRS9531.

Enrollment

7 estimated patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content and potential adverse reactions.
Healthy male subjects aged between 18 and 55 years (inclusive), determined at the time of signing the informed consent.
Body weight ≥50 kg, and the body mass index (BMI) between 19 to 32.5 kg/m2.
From the signing of the informed consent form until 12 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan.

Exclusion criteria

History of any clinically important disease or disorder.
History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug.
Physical examination, vital signs or other laboratory measurements, other electrocardiographic parameters, abdominal ultrasound (except mild fatty liver), and abnormalities on chest radiography as judged by the investigator to be clinically significant.
The subject was considered by the investigator to have any other factors that would preclude him from participating in the study or the subject withdrew from the study due to his own reasons.