NCT06609460

Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications

A Phase 2b Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study to Evaluate Efficacy and Safety of CD388, a Novel Long-acting Antiviral Conjugate, for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5,071 (actual)
• Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 63 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, and to select a dose of CD388 that is effective in preventing the same, when administered as a single dose via 3 subcutaneous (SQ) injections to adult participants in stable health, and to evaluate the safety and tolerability of CD388, as compared to placebo.

Detailed description

This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter dose selection study to evaluate the efficacy, safety, and tolerability of 3 dose levels of CD388 administered as a single dose via 3 SQ injections in adult participants who are not at risk of developing complications from influenza.

Conditions

• Influenza

Interventions

Type	Name	Description
COMBINATION_PRODUCT	CD388 Injection	CD388 liquid for injection
COMBINATION_PRODUCT	Placebo	Placebo to match

Timeline

• Start date: 2024-09-20
• Primary completion: 2025-09-19
• Completion: 2025-09-19
• First posted: 2024-09-24
• Last updated: 2025-10-20

Locations

57 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study