NCT05523089

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

A Proof-of-concept, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Assess the Prophylactic Antiviral Activity Against Influenza, Safety, Tolerability, and Pharmacokinetics of CD388 Via a Human Viral Challenge Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single-center, randomized, double-blind, placebo-controlled, proof-of-concept study in healthy adult male and female participants 18 to 55 years of age, inclusive. The primary goal of this Phase 2a study is to assess the prophylactic antiviral activity against influenza, safety, tolerability, and pharmacokinetics (PK) of CD388 via a human viral challenge (HVC) model, and to explore the impact of dose levels on efficacy. Each participant will receive a single administration of CD388 or placebo; multiple dose levels of CD388 may be evaluated.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Saline placebo	Sterile normal saline for injection
COMBINATION_PRODUCT	CD388	CD388 liquid for injection

Timeline

• Start date: 2022-09-09
• Primary completion: 2023-07-17
• Completion: 2023-07-17
• First posted: 2022-08-31
• Last updated: 2024-09-19
• Results posted: 2024-09-05

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study