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ACTIVE NOT RECRUITING
NCT07159763
PHASE3

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

Sponsor: Cidara Therapeutics Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7500

Start Date

2025-09-25

Completion Date

2027-01

Last Updated

2026-02-23

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

CD388 Injection

CD388 liquid for injection

COMBINATION_PRODUCT

Placebo

Placebo to match

Locations (150)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

HOPE Research Institute

Glendale, Arizona, United States

Desert Clinical Research, LLC / Avacare

Mesa, Arizona, United States

Foothills Research Center / Avacare

Phoenix, Arizona, United States

Fiel Family and Sports Medicine / Avacare

Tempe, Arizona, United States

HOPE Research Institute

Tempe, Arizona, United States

Arizona Clinical Trials

Tucson, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

Triallogix Medical Corporation

Fullerton, California, United States

National Institute of Clinical Research, Inc.

Garden Grove, California, United States

Eximia Research-CA, LLC

La Mesa, California, United States

Kinetic Clinical Research, LLC dba Long Beach Clinical Trials

Long Beach, California, United States

Seaside Medical Group

Oceanside, California, United States

Profound Research, LLC

Pasadena, California, United States

Paradigm Clinical Research

Redding, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Acclaim Clinical Research

San Diego, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Tekton Research, LLC

Denver, Colorado, United States

Tekton Research, LLC

Fort Collins, Colorado, United States

Critical Care, Pulmonary and Sleep Associates PLLP / Avacare

Lakewood, Colorado, United States

Tekton Research, LLC

Longmont, Colorado, United States

New England Research Associates

Bridgeport, Connecticut, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Emerson Clinical Research Institute

Washington D.C., District of Columbia, United States

Imagine Research - Palm Beach County

Boynton Beach, Florida, United States

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Hillcrest Medical Research, LLC

DeLand, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Columbus Clinical Services, LLC

Miami, Florida, United States

Flourish Research - Miami, LLC DBA Flourish Research

Miami, Florida, United States

South Florida Research Center, Inc.

Miami, Florida, United States

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States

Healthcare Clinical Data, Inc.

North Miami, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Health Awareness, Inc.

Port Saint Lucie, Florida, United States

Global Clinical Professionals

St. Petersburg, Florida, United States

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, United States

Agile Clinical Research Trials, LLC

Atlanta, Georgia, United States

DelRicht Research

Atlanta, Georgia, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Paradigm Clinical Research

Boise, Idaho, United States

Velocity Clinical Research - Boise

Meridian, Idaho, United States

Great Lakes Clinical Trials, LLC dba Flourish Research

Chicago, Illinois, United States

Velocity Clinical Research - Valparaiso

Valparaiso, Indiana, United States

Integrated Clinical Trial Services, LLC

West Des Moines, Iowa, United States

Johnson County Clin-Trials, LLC

Lenexa, Kansas, United States

AMR Clinical

Newton, Kansas, United States

DelRicht Research

Louisville, Kentucky, United States

Elevate Clinical Research

Lake Charles, Louisiana, United States

DelRicht Research

New Orleans, Louisiana, United States

DelRicht Research

Prairieville, Louisiana, United States

Annapolis Internal Medicine / Avacare

Annapolis, Maryland, United States

Jadestone Clinical Research, LLC

Silver Spring, Maryland, United States

Skylight Health Research

Burlington, Massachusetts, United States

Profound Research, LLC

Clarkston, Michigan, United States

Profound Research, LLC

Dearborn, Michigan, United States

Profound Research, LLC

Farmington Hills, Michigan, United States

Javara, Inc.

Mankato, Minnesota, United States

DelRicht Research

Gulfport, Mississippi, United States

Clay Platte Family Medicine, PC / Avacare

Kansas City, Missouri, United States

DelRicht Research

Springfield, Missouri, United States

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Montana Medical Research, Inc.

Missoula, Montana, United States

Methodist Physicians Clinic / Avacare

Fremont, Nebraska, United States

Velocity Clinical Research - Omaha

Omaha, Nebraska, United States

Midwest Regional Health Services, LLC / Avacare

Omaha, Nebraska, United States

Henderson Clinical Trials

Henderson, Nevada, United States

Excel Clinical Research

Las Vegas, Nevada, United States

Santa Rosa Medical Centers of Nevada / Avacare

Las Vegas, Nevada, United States

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, United States

IMA Clinical Research

Warren Township, New Jersey, United States

Brooklyn Clinical Research

Brooklyn, New York, United States

Finger Lakes Medical Research, PLLC dba Certified Research Associates

Cortland, New York, United States

Drug Trials America

Hartsdale, New York, United States

Rochester Clinical Research

Rochester, New York, United States

CHEAR Center, LLC

The Bronx, New York, United States

DelRicht Research

Charlotte, North Carolina, United States

Eximia EquiHealth Research, LLC

Durham, North Carolina, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

West Clinical Research, Inc.

Morehead City, North Carolina, United States

OnSite Clinical Solutions, LLC

Salisbury, North Carolina, United States

Wilmington Health

Wilmington, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Velocity Clinical Research - Cleveland

Beachwood, Ohio, United States

Velocity Clinical Research - Springdale

Cincinnati, Ohio, United States

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States

PriMed Clinical Research

Dayton, Ohio, United States

Tekton Research, LLC

Edmond, Oklahoma, United States

Lynn Health Science Institute East

Oklahoma City, Oklahoma, United States

DelRicht Research

Tulsa, Oklahoma, United States

Tekton Research, LLC

Yukon, Oklahoma, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Central Erie Primary Care

Erie, Pennsylvania, United States

Hatboro Medical Associates / Avacare

Horsham, Pennsylvania, United States

DM Clinical Research

Philadelphia, Pennsylvania, United States

DelRicht Research

Charleston, South Carolina, United States

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina, United States

DelRicht Research

Hendersonville, Tennessee, United States

DCT-HCWC, LLC dba Discovery Clinical Trials

Dallas, Texas, United States

Zenos Clinical Research

Dallas, Texas, United States

Lonestar Clinical Research, LLC

Dallas, Texas, United States

Laguna Clinical Research Associates, LLC

Laredo, Texas, United States

Epic Clinical Research

Lewisville, Texas, United States

Elevate Clinical Research

McAllen, Texas, United States

Pearland Physicians

Pearland, Texas, United States

Research Your Health

Plano, Texas, United States

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, United States

Elevate Clinical Research

Seabrook, Texas, United States

Javara, Inc.

Stephenville, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Cope Family Medicine / Avacare

Bountiful, Utah, United States

Olympus Family Medicine / Avacare

Salt Lake City, Utah, United States

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Rainier Clinical Research Center

Renton, Washington, United States

Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, United Kingdom

Fylde Coast Clinical Research at Layton Medical Centre

Blackpool, England, United Kingdom

Southmead Hospital, North Bristol NHS Trust - Clinical Research Centre

Bristol, England, United Kingdom

Velocity Clinical Research - Bristol

Bristol, England, United Kingdom

Eynsham Medical Centre

Eynsham, England, United Kingdom

Velocity Clinical Research - High Wycombe

High Wycombe, England, United Kingdom

HMC Health, The Meadows Centre for Health, The Great West Surgery

Hounslow, England, United Kingdom

Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

Leeds, England, United Kingdom

University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

Leicester, England, United Kingdom

hVIVO Services Limited

London, England, United Kingdom

Panthera Enfield

London, England, United Kingdom

Velocity Clinical Research - North London

London, England, United Kingdom

North Manchester General Hospital

Manchester, England, United Kingdom

The University of Nottingham Health Service

Nottingham, England, United Kingdom

Wansford Research LTD

Peterborough, England, United Kingdom

University Hospitals Plymouth NHS Trust

Plymouth, England, United Kingdom

Panthera Preston

Preston, England, United Kingdom

Panthera Rochdale

Rochdale, England, United Kingdom

Velocity Clinical Research - Romford

Romford, England, United Kingdom

Warrington and Halton Teaching Hospitals NHS Foundation Trust

Runcorn, England, United Kingdom

Salford Royal Hospital

Salford, England, United Kingdom

Panthera Sheffield

Sheffield, England, United Kingdom

University Hospital Southampton NHS Foundation Trust, NIHR Southampton Clinical Research Facility

Southampton, England, United Kingdom

Royal Cornwall Hospitals NHS Trust

Truro, England, United Kingdom

Windrush Medical Practice

Witney, England, United Kingdom

Panthera York

York, England, United Kingdom

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom

NHS Lothian - Western General Hospital

Edinburgh, Scotland, United Kingdom

Queen Elizabeth University Hospital, Glasgow Clinical Research Facility

Glasgow, Scotland, United Kingdom

Cardiff and Vale UHB - University Hospital of Wales

Cardiff, Wales, United Kingdom