NCT07159763

A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of CD388, a Novel Long-Acting Antiviral Conjugate, for the Prevention of Influenza in Adults and Adolescents at Higher Risk of Developing Influenza Complications

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,500 (estimated)
• Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how well CD388 works in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, when given as a single dose via 3 subcutaneous (SQ) injections to adult and adolescent participants who are at higher risk of developing influenza complications, and to evaluate the safety and tolerability of CD388, as compared to placebo.

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, and tolerability of CD388 administered as a single dose via 3 SQ injections in adult and adolescent participants who are at higher 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: 2025-09-25
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-09-08
• Last updated: 2026-02-23

Locations

150 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study