Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 Illness

Phase 1/2 Completed 162 enrolled Immune Biosolutions Inc

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase 1/2, randomized, double-blind, placebo-controlled, single-dose escalating-dose study in participants with mild to moderate COVID-19 illness.

Timeline

Start: 2021-09-29
Primary completion: 2023-01-04
Completion: 2023-01-04

Outcome

Missed primary endpoint

paper was -0·29 log10 copies per mL (95% CI -1·32 to 0·75; p=0·45) in the FAS population PMID 37619584 ↗

paper Despite the lack of significant reduction of viral load at day 5 PMID 37619584 ↗

Publications

Maranda B, Labbe SM, Lurquin M, Brabant P, Fugere A, Larrivee JF, Grbic D, Leroux A, Leduc F, Finzi A, Gaudreau S, Swart Y; IBIO-INH-001 Investigators. Safety and efficacy of inhaled IBIO123 for mild-to-moderate COVID-19: a randomised, double-blind, dose-ascending, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2024 Jan;24(1):25-35. doi: 10.1016/S1473-3099(23)00393-6. Epub 2023 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IBIO123	Monoclonal antibody	1 mg	Inhaled
Subject	IBIO123	Monoclonal antibody	5 mg	Inhaled
Subject	IBIO123	Monoclonal antibody	10 mg	Inhaled