The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults

Phase 2 Completed 59 enrolled Cidara Therapeutics Inc. Janssen Pharmaceuticals · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the preventative antiviral activity of CD388, as compared to saline placebo, when administered as a single dose to healthy adult participants in a human viral challenge model of influenza.

Timeline

Start: 2022-09-09
Primary completion: 2023-07-17
Completion: 2023-07-17

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs 150 mg CD388; p = 0.0390; Hodges-Lehmann estimator -1.2 (95% CI -5.7 to 0.0); Wilcoxon (Mann-Whitney); note: alpha = 0.025 one-sided NCT05523089 ↗

Publications

Rojas RE, Equils O, Villacian J, Mann A, van Duijnhoven W, Vingerhoets J, Baguet T, Wang SS, Anandakumar A, Anger A, Tourneroche A, Silva IG, Flanagan S. Prophylactic Efficacy of CD388, a Novel Drug-Fc Conjugate, in a Human Influenza A/H3N2 Virus Challenge Model: A Randomized, Controlled Phase 2a Study. Clin Infect Dis. 2025 Dec 24;81(5):e310-e318. doi: 10.1093/cid/ciaf465.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CD388	Other / unclassified	50 mg	Subcutaneous
Subject	CD388	Other / unclassified	150 mg	Subcutaneous