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Clinical Trial Summary

Gates MRI-RSM01-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and tolerability, pharmacokinetics, occurrence of ADA, and assessment of neutralizing antibody against RSV after administration of single intravenous or intramuscular doses of RSM01 to healthy adults.

Clinical Trial Description

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) among infants and young children, resulting in annual epidemics worldwide. RSM01, a monoclonal antibody targeting RSV, may potentially provide an effective method to protect infants from RSV disease based on its potency and an extended half-life that is expected to support once-per-RSV-season administration. This study is a first-in-human evaluation of RSM01 in healthy male and female adults with the goal of characterizing the safety and tolerability of a range of single doses of RSM01 to enable determination of appropriate dose(s) to be administered to infants in a future study. Enrollment is planned at a single study center in the United States. Approximately 56 participants will be enrolled; 48 participants to receive RSM01 and 8 participants to received placebo. Participants will be followed for approximately 5 months (151 days) after dosing. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05118386
Study type Interventional
Source Bill & Melinda Gates Medical Research Institute
Contact Gates MRI
Phone 1-866-789-5767
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date November 2021
Completion date August 5, 2022

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