drugset / Trial / NCT05626179

A Study of [14C]IBI351 in Healthy Subjects

NCT05626179

Phase 1 Completed 6 enrolled Innovent Biologics (Suzhou) Co. Ltd.
NaSingle-groupOpen-labelOther

Summary

This study is to evaluate the mass balance of single oral dose of \[14C\] IBI351 in healthy subjects. Six to eight healthy male subjects were planned to be enrolled. After passing the screening, subjects were admitted to hospital and received training on medication, urine and feces collection and other procedures to ensure that they could perform relevant operations according to the protocol and SOP requirements. On the evening before medication, the patient had standard meals, and fasted uniformly overnight. On D1, the suspension containing recommended dose of \[14C\] IBI351 was administered in the morning on an empty stomach. Subjects have standardized meal during the trial and blood, urine, and feces samples were collected and safety laboratory tests were performed as scheduled.

Timeline

Start
2023-02-18
Primary completion
2023-03-30
Completion
2023-05-18

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI351 Small molecule Oral

Indications

No indication recorded.