What is CD388 studying for influenza?

CD388 is being studied to see how well it prevents symptomatic influenza infections in people at higher risk for complications. The trial compares CD388 to a placebo and also checks the safety and tolerability of the treatment. The study is sponsored by Cidara Therapeutics, a subsidiary of Merck & Co.

Who may be eligible for this influenza clinical trial?

People aged 12 years or older who are at higher risk for influenza complications may be eligible. Participants must weigh at least 40 kilograms, be medically stable, and have negative influenza and COVID-19 tests before dosing. This study is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this influenza clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal expenses such as travel costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 12Years +

All Genders

ID07159763

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating CD388, a Long-Acting Antiviral, for Prevention of Influenza in Adolescents and Adults at Higher Risk

Led by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Updated on 2026-06-01

7500

Participants Needed

181

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating CD388, a long-acting antiviral treatment, to prevent symptomatic influenza infections in adults and adolescents at higher risk for influenza complications. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well CD388 works compared to placebo, as well as its safety and tolerability. Participants are randomly assigned to receive either a single dose of 450 mg CD388 or a matching placebo, both given by three subcutaneous injections. The study is conducted across multiple centers and includes participants aged 12 years and older. The trial compares the incidence of influenza-like illness starting from 7 days after dosing up to 24 weeks later. During the study, participants undergo screening tests including rapid antigen tests for influenza and COVID-19 before dosing. Researchers monitor participants for influenza-like illness, collect blood samples at several visits to measure CD388 levels and immune responses, and record any side effects. The overall participation lasts up to about 24 weeks, during which adherence to study procedures and safety are closely followed.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 12Years +

All Genders

Eligibility Criteria

You may qualify if you...

Must be 12 years of age or older at the time of informed consent.
Provide written informed consent; for minors, parental consent and assent as applicable.
Negative rapid antigen tests for influenza and COVID-19 before dosing.
Weight at least 40 kilograms at screening.
Body Mass Index (BMI) of 18 kg/m² or higher at screening.
Able to comply with study procedures, use electronic diaries or devices, and understand questionnaires.
Medically stable without significant recent changes in therapy or hospitalizations within 2 months.
Agree to contraception requirements if female of childbearing potential.
Agree not to donate blood or blood products from Day 1 until 32 weeks after dosing.
Willing to provide identification and reliable contact during the study.
Meet criteria for higher risk non-immunocompromised or immunocompromised groups as defined by specific health conditions.

You will not qualify if you...

Pregnant or lactating females.
Allergy or serious reaction history to zanamivir, monoclonal antibodies, CD388, or placebo components.
Diagnosis of influenza within 6 months before randomization.
Received current seasonal influenza vaccine within 14 days prior to dosing.
Acute or febrile illness within 7 days prior to dosing.
Close contact with lab-confirmed influenza or COVID-19 cases within 7 days prior to randomization.
Clinically unstable conditions or psychiatric issues that may affect participation.
History of alcohol or drug abuse affecting study conduct.
Major surgery within 4 weeks prior to randomization or planned during study.
Severe chronic kidney disease or receiving hemodialysis.
Abnormal ECG findings unless stable and explained by known condition.
Participation in another clinical study with study intervention during this study.
Recent use of drugs or biologics for influenza prevention or treatment.
Significant bleeding disorders or recent blood donation.
Direct involvement or conflict of interest with the study team or sponsor.
Any condition increasing risk, impairing participation, or affecting data interpretation as judged by the investigator.

Research Team

Head of Clinical Operations

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