CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
RSM01 +1 moredrug
Likely dose
RSM01 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05118386
NCT05118386Phase 1Completed
CompareCT.gov

A Phase 1 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of RSM01, a Monoclonal Antibody Targeting Respiratory Syncytial Virus, in Healthy Adults

Gates Medical Research Institute·interventional·Posted Nov 12, 2021·Updated May 20, 2024

In Brief

A Phase 1 clinical trial evaluating RSM01 and Placebo for RSV Infection. Completed, enrolled 56 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRSV Infection
CountriesUnited States
CollaboratorsPPD Phase I Clinic - Orlando

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedNov 12, 2021
Enrollment StartNov 16, 2021
Primary CompletionAug 23, 2022
Study CompletionDec 7, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.6 years ago

Interventions

RSM01drug

Cohort 1: RSM01 300 mg IV Cohort 2: RSM01 300 mg IM Cohort 3: RSM01 1000 mg IV Cohort 4: RSM01 3000 mg IV Cohort 5: RSM01 600 mg IM

Placeboother

Cohort 1: Placebo IV Cohort 2: Placebo IM Cohort 3: Placebo IV Cohort 4: Placebo IV Cohort 5: Placebo IM