A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza
NCT07159763 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7500
Last updated 2026-05-19
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.
Conditions
Interventions
- COMBINATION_PRODUCT
-
CD388 Injection
CD388 liquid for injection
- COMBINATION_PRODUCT
-
Placebo
Placebo to match
Sponsors & Collaborators
-
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
lead INDUSTRY
Principal Investigators
-
Barbara Haber, MD · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-25
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- United Kingdom
Study Locations
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