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Monoclonal Antibodies
Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults
Phase 1
Waitlist Available
Research Sponsored by Bill & Melinda Gates Medical Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 151
Summary
This trial tested RSM01, a medicine designed to fight RSV, in healthy adults. The goal was to ensure it is safe and determine the right dose before using it in infants. RSM01 helps the immune system recognize and attack the RSV virus.
Eligible Conditions
- Respiratory Syncytial Virus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 151
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 151
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151
Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
+1 moreSecondary study objectives
Apparent Terminal Half-Life After Administration of RSM01
Apparent Total Body Clearance (CL) After Intramuscular Dose Administration of RSM01
Apparent Volume of Distribution (Vz) After Intramuscular Dose Administration of RSM01
+13 moreOther study objectives
To characterize RSV neutralizing antibody activity following RSM01 administration
Side effects data
From 2022 Phase 1 trial • 56 Patients • NCT0511838617%
Blood pressure increased
17%
COVID-19
17%
Alanine aminotransferase increased
17%
Aspartate aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
RSM01 3000 mg IV
RSM01 600 mg IM
RSM01 300 mg IV
Placebo
RSM01 1000 mg IV
RSM01 300 mg IM
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RSM01Experimental Treatment1 Intervention
Participants were randomized to receive different dose levels of RSM01. Participants were randomized in a ratio of 6:1 where for every 6 participants received active drug (RSM01), 1 participant received Placebo.
Group II: PlaceboPlacebo Group1 Intervention
Participants received Placebo matched to RSM01.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSM01
2021
Completed Phase 1
~60
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Bill & Melinda Gates Medical Research InstituteLead Sponsor
14 Previous Clinical Trials
32,057 Total Patients Enrolled
PPD Phase I Clinic - OrlandoUNKNOWN
Gates MRIStudy DirectorBill & Melinda Gates Medical Research Institute
8 Previous Clinical Trials
31,004 Total Patients Enrolled