NCT05688124

A Study of IBI351 in Healthy Subjects

A Randomized, Open-label, Two-cycle Clinical Study to Evaluate the Drug Interaction, Food Effect and Pharmacokinetics of IBI351 With Esomeprazole in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, two-cycle clinical study to evaluate the drug interaction, food effect and pharmacokinetics of IBI351 and esomeprazole in healthy subjects. A total of two cohorts were planned to be enrolled in each cohort. Cohort 1: This cohort investigated the effect of esomeprazole on the pharmacokinetics of IBI351 in healthy subjects. Cohort 2: This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	IBI351	IBI351 is administered orally
DRUG	Esomeprazole	Esomeprazole is administered orally

Timeline

• Start date: 2023-02-16
• Primary completion: 2023-10-16
• Completion: 2023-10-16
• First posted: 2023-01-18
• Last updated: 2023-10-24

Locations

1 site across 1 country: China