Cidara starts Phase 2a Human Challenge Flu Trial

 CD388 is a drug-Fc conjugate (DFC) from Cidara’s Cloudbreak® platform designed to help transform the standard of care for seasonal and pandemic influenza prevention

Study is being conducted in collaboration with Janssen

Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, today announced the initiation of its Phase 2a trial to evaluate the pre-exposure prophylactic activity of CD388 against influenza virus. CD388 is a highly potent, long-acting antiviral designed to deliver universal prevention of seasonal and pandemic influenza. The study is being conducted under an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize Cidara’s Cloudbreak® drug-Fc conjugates (DFCs) for the prevention of seasonal and pandemic influenza.

The Phase 2a trial (NCT05523089), which dosed its first healthy volunteer on September 10th, is a single-center, randomized, double-blind, placebo-controlled, proof-of-concept study to assess the prophylactic antiviral activity, safety, tolerability and pharmacokinetics of CD388 against influenza via a human viral challenge (influenza) model, and to explore the impact of dose levels on efficacy. Multiple dose levels of CD388 will be evaluated in volunteers who will receive a single administration of CD388 or placebo prior to influenza viral challenge. The trial is expected to enroll up to 168 healthy adults.

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