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

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study ID
NCT07159763
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD388 Injection — COMBINATION_PRODUCT
    CD388 liquid for injection
  • Placebo — COMBINATION_PRODUCT
    Placebo to match

Study Details

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.

Key Dates

Start date
Sep 25, 2025
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
7,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CD388
    Participants are randomized to receive 450 milligrams (mg) CD388 by SQ injection. Participants are randomized at a 1:1 ratio between the 2 arms.
  • Placebo Comparator: Placebo
    Participants are randomized to receive placebo by SQ injection. Participants are randomized at a 1:1 ratio between the 2 arms.

Primary Outcome Measure

Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug [ Time Frame: From Day 8 up to 24 weeks after study drug dosing ]

Central Contacts

Locations (120)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group, LLCAnnistonAlabama36207-
Cullman Clinical TrialsCullmanAlabama35055-
HOPE Research InstituteGlendaleArizona85308-
Desert Clinical Research, LLC / AvacareMesaArizona85213-
Foothills Research Center / AvacarePhoenixArizona85044-
Fiel Family and Sports Medicine / AvacareTempeArizona85283-
HOPE Research InstituteTempeArizona85284-
Arizona Clinical TrialsTucsonArizona85711-
Del Sol Research Management, LLCTucsonArizona85715-
Triallogix Medical CorporationFullertonCalifornia92835-
National Institute of Clinical Research, Inc.Garden GroveCalifornia92844-
Eximia Research-CA, LLCLa MesaCalifornia91942-
Kinetic Clinical Research, LLC dba Long Beach Clinical TrialsLong BeachCalifornia90806-
Seaside Medical GroupOceansideCalifornia92058-
Profound Research, LLCPasadenaCalifornia91105-
Paradigm Clinical ResearchReddingCalifornia96001-
Acclaim Clinical ResearchSan DiegoCalifornia92120-
Artemis Institute for Clinical ResearchSan DiegoCalifornia92103-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Tekton Research, LLCDenverColorado80238-
Tekton Research, LLCFort CollinsColorado80525-
Critical Care, Pulmonary and Sleep Associates PLLP / AvacareLakewoodColorado80228-
Tekton Research, LLCLongmontColorado80501-
New England Research AssociatesBridgeportConnecticut06606-
Stamford Therapeutics ConsortiumStamfordConnecticut06905-
Emerson Clinical Research InstituteWashington D.C.District of Columbia20009-
Imagine Research - Palm Beach CountyBoynton BeachFlorida33435-
Innovative Research of West Florida, Inc.ClearwaterFlorida33756-
Hillcrest Medical Research, LLCDeLandFlorida32720-
Health Awareness, Inc.JupiterFlorida33458-
Columbus Clinical Services, LLCMiamiFlorida33125-
Flourish Research - Miami, LLC DBA Flourish ResearchMiamiFlorida33135-
South Florida Research Center, Inc.MiamiFlorida33135-
Floridian Clinical Research, LLCMiami LakesFlorida33016-
Healthcare Clinical Data, Inc.North MiamiFlorida33161-
Clinical Neuroscience Solutions, Inc.OrlandoFlorida32806-
Progressive Medical ResearchPort OrangeFlorida32127-
Health Awareness, Inc.Port Saint LucieFlorida34952-
Global Clinical ProfessionalsSt. PetersburgFlorida33705-
Clinical Site Partners, LLC dba Flourish ResearchWinter ParkFlorida32789-
Agile Clinical Research Trials, LLCAtlantaGeorgia30328-
DelRicht ResearchAtlantaGeorgia30329-
Clinical Research AtlantaStockbridgeGeorgia30281-
Paradigm Clinical ResearchBoiseIdaho83709-
Velocity Clinical Research - BoiseMeridianIdaho83642-
Great Lakes Clinical Trials, LLC dba Flourish ResearchChicagoIllinois60640-
Velocity Clinical Research - ValparaisoValparaisoIndiana46383-
Integrated Clinical Trial Services, LLCWest Des MoinesIowa50265-
Johnson County Clin-Trials, LLCLenexaKansas66219-
AMR ClinicalNewtonKansas67114-
DelRicht ResearchLouisvilleKentucky40205-
Elevate Clinical ResearchLake CharlesLouisiana70605-
DelRicht ResearchNew OrleansLouisiana70115-
DelRicht ResearchPrairievilleLouisiana70769-
Annapolis Internal Medicine / AvacareAnnapolisMaryland21401-
Jadestone Clinical Research, LLCSilver SpringMaryland20904-
Skylight Health ResearchBurlingtonMassachusetts01803-
Profound Research, LLCClarkstonMichigan48346-
Profound Research, LLCDearbornMichigan48126-
Profound Research, LLCFarmington HillsMichigan48334-
Javara, Inc.MankatoMinnesota56001-
DelRicht ResearchGulfportMississippi39503-
Clay Platte Family Medicine, PC / AvacareKansas CityMissouri64151-
DelRicht ResearchSpringfieldMissouri65807-
Sundance Clinical Research, LLCSt LouisMissouri63141-
Montana Medical Research, Inc.MissoulaMontana59808-
Methodist Physicians Clinic / AvacareFremontNebraska68025-
Midwest Regional Health Services, LLC / AvacareOmahaNebraska68144-
Velocity Clinical Research - OmahaOmahaNebraska68134-
Henderson Clinical TrialsHendersonNevada89052-
Excel Clinical ResearchLas VegasNevada89109-
Santa Rosa Medical Centers of Nevada / AvacareLas VegasNevada89119-
Las Vegas Clinical Trials, LLCNorth Las VegasNevada89030-
IMA Clinical ResearchWarren TownshipNew Jersey07059-
Brooklyn Clinical ResearchBrooklynNew York11226-
Finger Lakes Medical Research, PLLC dba Certified Research AssociatesCortlandNew York13045-
Drug Trials AmericaHartsdaleNew York10530-
Rochester Clinical ResearchRochesterNew York14609-
CHEAR Center, LLCThe BronxNew York10455-
DelRicht ResearchCharlotteNorth Carolina28205-
Eximia EquiHealth Research, LLCDurhamNorth Carolina27704-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
West Clinical Research, Inc.Morehead CityNorth Carolina28557-
OnSite Clinical Solutions, LLCSalisburyNorth Carolina28144-
Wilmington HealthWilmingtonNorth Carolina28412-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Velocity Clinical Research - ClevelandBeachwoodOhio44122-
Velocity Clinical Research - SpringdaleCincinnatiOhio45246-
Centricity Research Columbus Ohio MultispecialtyColumbusOhio43213-
PriMed Clinical ResearchDaytonOhio45429-
Tekton Research, LLCEdmondOklahoma73013-
Lynn Health Science Institute EastOklahoma CityOklahoma73111-
DelRicht ResearchTulsaOklahoma74133-
Tekton Research, LLCYukonOklahoma73099-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Central Erie Primary CareEriePennsylvania16508-
Hatboro Medical Associates / AvacareHorshamPennsylvania19044-
DM Clinical ResearchPhiladelphiaPennsylvania19107-
DelRicht ResearchCharlestonSouth Carolina29407-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
Spartanburg Medical ResearchSpartanburgSouth Carolina29303-
Velocity Clinical Research - SpartanburgSpartanburgSouth Carolina29303-
DelRicht ResearchHendersonvilleTennessee37075-
DCT-HCWC, LLC dba Discovery Clinical TrialsDallasTexas75230-
Lonestar Clinical Research, LLCDallasTexas75243-
Zenos Clinical ResearchDallasTexas75230-
Laguna Clinical Research Associates, LLCLaredoTexas78041-
Epic Clinical ResearchLewisvilleTexas75057-
Elevate Clinical ResearchMcAllenTexas78504-
Pearland PhysiciansPearlandTexas77581-
Research Your HealthPlanoTexas75093-
Clinical Trials of Texas, LLC dba Flourish ResearchSan AntonioTexas78229-
Elevate Clinical ResearchSeabrookTexas77586-
Javara, Inc.StephenvilleTexas76401-
DM Clinical ResearchTomballTexas77375-
Cope Family Medicine / AvacareBountifulUtah84010-
Olympus Family Medicine / AvacareSalt Lake CityUtah84117-
Charlottesville Medical Research Center, LLCCharlottesvilleVirginia22911-
Clinical Research Partners, LLCRichmondVirginia23226-
Rainier Clinical Research CenterRentonWashington98057-

Find similar trials in Anniston, AL

By research site
Pinnacle Research Group, LLC· Anniston, ALCullman Clinical Trials· Cullman, ALHOPE Research Institute· Glendale, AZDesert Clinical Research, LLC / Avacare· Mesa, AZFoothills Research Center / Avacare· Phoenix, AZFiel Family and Sports Medicine / Avacare· Tempe, AZ

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