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

PHASE1CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

November 16, 2021

Primary Completion Date

August 23, 2022

Study Completion Date

December 7, 2022

Conditions
RSV Infection
Interventions
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"

Trial Locations (1)

32806-1041

PPD Phase I Clinic - Orlando, Orlando

All Listed Sponsors
collaborator

PPD Phase I Clinic - Orlando

OTHER

lead

Gates Medical Research Institute

OTHER