NCT05118386

Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed 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 was 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 was planned at a single study center in the United States. 56 participants were enrolled; 48 participants received RSM01 and 8 participants received Placebo. Participants were followed for approximately 5 months (151 days) after dosing.

Conditions

• RSV Infection

Interventions

Type	Name	Description
DRUG	RSM01	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
OTHER	Placebo	Cohort 1: Placebo IV Cohort 2: Placebo IM Cohort 3: Placebo IV Cohort 4: Placebo IV Cohort 5: Placebo IM

Timeline

• Start date: 2021-11-16
• Primary completion: 2022-08-23
• Completion: 2022-12-07
• First posted: 2021-11-12
• Last updated: 2024-05-20
• Results posted: 2024-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study