Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

September 20, 2018

Primary Completion Date

September 14, 2022

Study Completion Date

September 14, 2022

Conditions
Respiratory Tract InfectionRespiratory Syncytial Virus
Interventions
DRUG

Clesrovimab

Single ascending doses of clesrovimab will be administered via IM injection.

DRUG

Placebo

Placebo (0.9% sodium chloride \[NaCl\]) will be administered via IM injection.

Trial Locations (34)

2013

Chris Hani Baragwanath Academic Hospital ( Site 0262), Johannesburg

7505

Tygerberg Hospital ( Site 0261), Cape Town

13210

SUNY Upstate Medical University Hospital ( Site 0029), Syracuse

15706

Hospital Clinico Universitario de Santiago ( Site 0241), Santiago de Compostela

27610

WakeMed Health and Hospitals ( Site 0033), Raleigh

28046

Hospital Universitario La Paz ( Site 0242), Madrid

29414

Coastal Pediatric Research ( Site 0028), Charleston

29607

Tribe Clinical Research, LLC ( Site 0082), Greenville

33030

Next Phase Research Alliance, LLC ( Site 0075), Homestead

33142

Acevedo Clinical Research Associates ( Site 0025), Miami

45229

Cincinnati Children's Hospital Medical Center ( Site 0031), Cincinnati

45414

Ohio Pediatric Research Association ( Site 0066), Dayton

53792

University of Wisconsin American Family Children's Hospital ( Site 0068), Madison

64108

Children's Mercy Hospital ( Site 0037), Kansas City

66604

Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0081), Topeka

77555

University of Texas Medical Branch at Galveston ( Site 0039), Galveston

78240

Tekton Research, Inc. ( Site 0026), San Antonio

80045

Children's Hospital - Colorado ( Site 0067), Aurora

96826

Kapiolani Medical Center for Women and Children ( Site 0027), Honolulu

98405

Multicare Institute For Research And Innovation ( Site 0035), Tacoma

110221

MedPlus Medicina Prepagada S.A. ( Site 0095), Bogotá

111411

Fundacion Universitaria de Ciencias de la Salud - Sociedad de Cirugia ( Site 0099), Bogotá

250001

Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0100), Chía

760032

Fundacion Valle del Lili ( Site 0090), Santiago de Cali

7650698

Centro de Investigacion Clinica Bradford Hill ( Site 0103), Santiago

8242238

Hospital La Florida ( Site 0050), Santiago

8380453

Facultad Medicina Universidad de Chile ( Site 0104), Santiago

8880465

Hospital Padre Hurtado ( Site 0102), Santiago

03766

Dartmouth-Hitchcock Medical Center ( Site 0032), Lebanon

050010

Fundacion Hospital San Vicente de Paul ( Site 0097), Medellín

050036

Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0098), Medellín

03080

Seoul National University Hospital ( Site 0071), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 0073), Seoul

06351

Samsung Medical Center ( Site 0072), Seoul

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03524118 - Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002) | Biotech Hunter | Biotech Hunter