Completed
A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Participants Inoculated With Experimental Respiratory Syncytial Virus
What is being tested
Clesrovimab
+ RSV-A Memphis 37b
+ Placebo
BiologicalOther
Who is being recruted
From 18 to 55 Years
+34 Eligibility Criteria
How is the trial designed
Prevention Study
Placebo-ControlledPhase 2
Interventional
Study Start: October 2019
Summary
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 28, 2019
Actual date on which the first participant was enrolled.The primary objective of this study is to determine if a single intravenous (IV) dose of clesrovimab when administered at 1 of 4 dose levels results in a reduction in viral load after intranasal inoculation (with RSV A Memphis 37b) compared to IV placebo. It is hypothesized that at least 1 of the 4 dose levels of clesrovimab given prior to inoculation will reduce the area under the viral load-time curve (VL-AUC) from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40) compared to placebo.
Official TitleA Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Participants Inoculated With Experimental Respiratory Syncytial Virus
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
Is a male or female 18 to 55 years of age in good health with no history of major medical conditions that will interfere with participant safety, as defined by medical history, physical examination (including vital signs), electrocardiogram (ECG), and routine laboratory tests and determined by the Investigator at a screening evaluation.
Has a total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m^2 and ≤ 30kg/m^2.
If male, agrees to study contraceptive requirements at dosing and continuing until 90 days after dosing or 28 days after viral inoculation (whichever is later) and to not donate sperm until 90 days after dosing.
If female, has a negative pregnancy test at screening and prior to dosing and agrees to use one form of highly effective contraception if a woman of childbearing potential (WOCBP), or is not a WOCBP.
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29 exclusion criteria prevent from participating
Is a female who is breastfeeding or has been pregnant within 6 months prior to enrollment.
Has a history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immune suppression), metabolic, urological, renal, neurological, or psychiatric disease (including participants with a history of depression and/or anxiety with associated severe psychiatric comorbidities.
Has any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral inoculation (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded).
Has any clinically significant history of epistaxis (large nosebleeds) within the last 3 months prior to IMP dosing and/or history of being hospitalized due to epistaxis on any previous occasion.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
5 intervention groups are designated in this study
20% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalParticipants receive a single IV infusion of clesrovimab 100 mg on Day 1.
Group II
ExperimentalParticipants receive a single IV infusion of clesrovimab 200 mg on Day 1.
Group III
ExperimentalParticipants receive a single IV infusion of clesrovimab 300 mg on Day 1.
Group IV
ExperimentalParticipants receive a single IV infusion of clesrovimab 900 mg on Day 1.
Group 5
PlaceboParticipants receive a single IV infusion of placebo on Day 1.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
HVIVO Services Ltd ( Site 0001)
London, United KingdomOpen HVIVO Services Ltd ( Site 0001) in Google MapsCompletedOne Study Center