NCT05162365

A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose-finding, inferentially seamless Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314 in Ambulatory Patients with COVID-19.

Detailed description

Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 32 ambulatory adult patients with COVID-19. This phase of the study is designed to assess the safety, tolerability, PK, and PD of IBI314 administered as a single IV infusion. Phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 208 ambulatory adult patients with COVID-19. This phase of the study is designed to assess the efficacy and safety of IBI314, administered by single IV infusion at dose levels that meet none of the termination criteria for dose escalation in Phase 1 of the study.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	IBI314	Low/medium/high dose, intravenously, once, on Day 1
OTHER	Placebo	Placebo, intravenously, once, on Day 1

Timeline

• Start date: 2022-01-06
• Primary completion: 2022-06-29
• Completion: 2022-11-18
• First posted: 2021-12-17
• Last updated: 2023-12-18

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study