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Monoclonal Antibodies

Panel B: Pre-term clesrovimab Dose 2 for Respiratory Infections

Phase 1 & 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at designated time points (up to 1 year post-dose)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for infants.

Eligible Conditions
  • Respiratory Infections
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at designated time points (up to 1 year post-dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at designated time points (up to 1 year post-dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Experienced At Least One Serious Adverse Event (SAE)
Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE)
Percentage of Participants Who Experienced At Least One Solicited Systemic Adverse Event (AE)
Secondary outcome measures
Apparent Terminal Half-life (t1/2) of Clesrovimab
Area Under the Serum-Concentration Time Curve From Zero to Infinity (AUC0-∞)
Maximum Serum Concentration (Cmax) of Clesrovimab
+7 more

Side effects data

From 2020 Phase 2 trial • 80 Patients • NCT04086472
38%
Headache
19%
Upper respiratory tract infection
6%
Abdominal discomfort
6%
COVID-19
6%
Catheter site bruise
6%
Haemorrhoids
6%
Epistaxis
6%
Oropharyngeal pain
6%
Rash
6%
Constipation
6%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-1654 200 mg
MK-1654 100 mg
MK-1654 300 mg
MK-1654 900 mg
Placebo

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Panel E2: Full-term clesrovimab Dose 4Experimental Treatment1 Intervention
Full-term infants enrolled after AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 545 days.
Group II: Panel E1: Full-term clesrovimab Dose 4Experimental Treatment1 Intervention
Full-term infants enrolled prior to AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 365 days.
Group III: Panel D2: Pre-term clesrovimab Dose 4Experimental Treatment1 Intervention
Pre-term infants enrolled after AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 545 days.
Group IV: Panel D1: Pre-term clesrovimab Dose 4Experimental Treatment1 Intervention
Pre-term infants enrolled prior to AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 365 days.
Group V: Panel C: Pre-term clesrovimab Dose 3Experimental Treatment1 Intervention
Pre-term infants will receive clesrovimab Dose 3 via IM injection and will be followed for up to 365 days.
Group VI: Panel B: Pre-term clesrovimab Dose 2Experimental Treatment1 Intervention
Pre-term infants will receive clesrovimab Dose 2 via IM injection and will be followed for up to 365 days.
Group VII: Panel A: Pre-term clesrovimab Dose 1Experimental Treatment1 Intervention
Pre-term infants will receive clesrovimab Dose 1 via intramuscular (IM) injection and will be followed for up to 365 days.
Group VIII: PlaceboPlacebo Group1 Intervention
Pre-term infants will receive placebo via IM injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clesrovimab
2019
Completed Phase 2
~270

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,952 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,890 Previous Clinical Trials
5,060,118 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,557 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
2018. "Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03524118.
~28 spots leftby Apr 2025
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