Efficacy & Safety of CD388 in Influenza Prevention: Double-Blind & Placebo-Controlled
Research type
Research Study
Full title
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
IRAS ID
1010492
Contact name
Joaquin Sosa
Contact email
Sponsor organisation
Cidara Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
A study to evaluate if CD388 can prevent influenza and to access the benefits and safety of CD388 in healthy adults. Influenza virus causes an infectious disease commonly known as ‘the flu’. The virus can spread easily through air, often by coughs and sneezes. The disease is often mild in children and most healthy people but can be severe in pregnant women, people older than 65yr, people whose immune system is down and people with chronic conditions like diabetes, asthma or heart failure.
To test the potential new drug, we will give healthy participants the study drug or placebo prior to the flu season. CD388 works by stopping the growth and spread of the virus in the body. The approved treatments for the flu are drugs called zanamivir and oseltamivir, but new drugs are needed because the flu virus may be becoming ‘resistant’ to these drugs. Up to 1000 healthy adults aged 18 - <64 will be invited to join in this research study.
CD388 will be given to 3 in 4 of the participants at allocated at random. Each group will receive different dose levels of CD388 or placebo but will not exceed the maximum dose of 450mg (three 150mg subcutaneous injections). Subjects who are randomly assigned to receive placebo will receive an injection under the skin in the same volume as the study drug.
This study has 3 stages: Screening, Treatment and Follow-Up. Participants will attend at least 1 study site visit for Screening, Randomisation, and to receive the study therapy on Study Day 1. Participants will then need to return to the study site for at least 4 safety check-up visits on Study Days 8, 29, 85, and 197 (EOS). Participants will have 3 telemedicine (via phone or video) visits on Study Days 15, 57, and 169. Additionally, if participants experience a respiratory (breathing) tract infection during the study, they will be required to visit the study site at least 1 time and potentially have 2 more remote visits. Involvement duration in the study is 197 days.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0227
Date of REC Opinion
5 Sep 2024
REC opinion
Further Information Favourable Opinion