NCT05626179

A Study of [14C]IBI351 in Healthy Subjects

A Mass Balance Study of [14C]IBI351 in Healthy Male Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	[14C] IBI351	The oral formulation of \[14C\] IBI351 was formulated as a suspension for subjects to take orally in drinking water under fasting conditions

Timeline

• Start date: 2023-02-18
• Primary completion: 2023-03-30
• Completion: 2023-05-18
• First posted: 2022-11-23
• Last updated: 2023-12-27

Locations

1 site across 1 country: China