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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Respiratory Tract Infection, Respiratory Syncytial Virus

In brief

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at \>35 weeks gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel prior to administering the next-highest dose.

Key facts

Study ID

NCT03524118

Run by

Merck Sharp & Dohme LLC

People needed

183

Starts

2018-09-20

Expected to finish

2022-09-14

Last updated by the study team

2025-01-14

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• is healthy, based on screening safety laboratory, medical history, and physical examination results
• is a pre-term infant (born at 29 weeks to 35 weeks gestational age [inclusive]) or a full-term infant (born at over 35 weeks gestational age), as confirmed in medical records
• weighs ≥2 kg at screening

You may not qualify if…

• has been recommended to receive palivizumab per local standard of care
• has ≥1 documented out-of-range safety laboratory results (adjusted for age) at the time of screening
• has a known hypersensitivity to any component of the respiratory syncytial virus (RSV) monoclonal antibody
• has a history of congenital or acquired immunodeficiency (e.g., splenomegaly)
• has documented human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg positive), or hepatitis C (HCV ribonucleic acid [RNA] positive)
• has known history of functional or anatomic asplenia
• has a diagnosis of failure to thrive within 14 days of screening
• has known or history of a coagulation disorder contraindicating intramuscular injection
• has received or is expected to receive blood products (except irradiated platelets) within 3 months prior to enrollment
• has prior known documented RSV infection
• has hemodynamically significant congenital heart disease
• has chronic lung disease of prematurity requiring ongoing medical therapy
• has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that, in the opinion of the investigator, might expose the participant to undue risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study
• has any history of malignancy prior to randomization
• if any of the following apply, the Day 1 visit may be rescheduled for a time when these criteria are not met:
• has had a recent febrile illness (rectal temperature 38.1°C [100.5°F] or higher or axillary temperature 37.8°C [100.0°F] or higher) within 72 hours pre-dose
• is not up-to-date on required vaccinations per local pediatric vaccine schedule at time of screening
• has received inactivated or component vaccines (eg, influenza, hepatitis B) less than 14 days pre-dose
• has received live, attenuated, non-study licensed pediatric vaccines (e.g., Bacillus Calmette-Guerin vaccine) less than 30 days pre-dose
• has received any prior vaccine or monoclonal antibody (mAb) for the prevention of RSV
• is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time prior to first dose administration or while participating in this current study (participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor)
• has enrolled previously in this study and been discontinued
• participant's mother participated in a RSV vaccine clinical study while pregnant and participant is ≤3 months of chronological age
• is unable to provide blood sample at screening
• cannot be adequately followed for safety according to the protocol plan

Where it is running

• Children's Hospital - Colorado ( Site 0067) — Aurora, Colorado, United States
• Next Phase Research Alliance, LLC ( Site 0075) — Homestead, Florida, United States
• Acevedo Clinical Research Associates ( Site 0025) — Miami, Florida, United States
• Kapiolani Medical Center for Women and Children ( Site 0027) — Honolulu, Hawaii, United States
• Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0081) — Topeka, Kansas, United States
• Children's Mercy Hospital ( Site 0037) — Kansas City, Missouri, United States
• Dartmouth-Hitchcock Medical Center ( Site 0032) — Lebanon, New Hampshire, United States
• SUNY Upstate Medical University Hospital ( Site 0029) — Syracuse, New York, United States
• WakeMed Health and Hospitals ( Site 0033) — Raleigh, North Carolina, United States
• Cincinnati Children's Hospital Medical Center ( Site 0031) — Cincinnati, Ohio, United States
• Ohio Pediatric Research Association ( Site 0066) — Dayton, Ohio, United States
• Coastal Pediatric Research ( Site 0028) — Charleston, South Carolina, United States
• Tribe Clinical Research, LLC ( Site 0082) — Greenville, South Carolina, United States
• University of Texas Medical Branch at Galveston ( Site 0039) — Galveston, Texas, United States
• Tekton Research, Inc. ( Site 0026) — San Antonio, Texas, United States
• Multicare Institute For Research And Innovation ( Site 0035) — Tacoma, Washington, United States
• University of Wisconsin American Family Children's Hospital ( Site 0068) — Madison, Wisconsin, United States
• Centro de Investigacion Clinica Bradford Hill ( Site 0103) — Santiago, Region M. de Santiago, Chile
• Hospital La Florida ( Site 0050) — Santiago, Region M. de Santiago, Chile
• Facultad Medicina Universidad de Chile ( Site 0104) — Santiago, Region M. de Santiago, Chile
• Hospital Padre Hurtado ( Site 0102) — Santiago, Region M. de Santiago, Chile
• Fundacion Hospital San Vicente de Paul ( Site 0097) — Medellín, Antioquia, Colombia
• Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0098) — Medellín, Antioquia, Colombia
• MedPlus Medicina Prepagada S.A. ( Site 0095) — Bogotá, Bogota D.C., Colombia
• Fundacion Universitaria de Ciencias de la Salud - Sociedad de Cirugia ( Site 0099) — Bogotá, Bogota D.C., Colombia

Full record on ClinicalTrials.gov

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