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Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants

NCT03524118•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Participants in Dose Panels A, B, C, D1, and E1 will be followed for up to 365 days. After protocol Amendment 4 (AM4), participants in Dose Panels D2 and E2 will be followed for up to 545 days.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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
+17 more criteria

Locations (34)

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

Key Dates

Start Date

September 20, 2018

Primary Completion Date

September 14, 2022

Completion Date

September 14, 2022

Last Updated

January 14, 2025

Enrollment

183

ACTUAL participants

Conditions

Respiratory Tract InfectionRespiratory Syncytial Virus

Interventions

Clesrovimab

DRUG

Placebo

DRUG

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

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RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

COVID-19 Impact on RSV Emergency Presentations

The Fever Clinic Acute Respiratory Cohort

Respiratory Infections in Young Children

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )