NCT05172141

A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314.

Detailed description

Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 24 health volunteers. This phase of the study is designed to assess the safety, tolerability and PK of IBI314 administered as a single IV infusion. Phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 198 mild to moderate adult patients with COVID-19. This phase of the study is designed to assess the efficacy, safety, PK and PD of IBI314.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	IBI314(low dose)	intravenously, once, on Day 1
BIOLOGICAL	IBI314(high dose)	intravenously, once, on Day 1
BIOLOGICAL	IBI314(medium dose)	intravenously, once, on Day 1
OTHER	Placebo	intravenously, once, on Day 1

Timeline

• Start date: 2021-12-31
• Primary completion: 2022-08-31
• Completion: 2023-01-31
• First posted: 2021-12-29
• Last updated: 2023-03-01

Locations

1 site across 1 country: China