At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Clesrovimab, Placebo, and 1 other intervention for Respiratory Syncytial Viruses. Completed, enrolled 80 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Single dose of clesrovimab administered via IV infusion.
Placebo (0.9% sodium chloride, USP sterile saline) administered via IV infusion.
Approximately 4Log10 plaque-forming units (PFU)/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.