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Monoclonal Antibodies

RSM01 for Respiratory Syncytial Virus

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 151 for reporting.

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 more

Secondary 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 more

Other study objectives

To characterize RSV neutralizing antibody activity following RSM01 administration

Side effects data

From 2022 Phase 1 trial • 56 Patients • NCT05118386

17%

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

RSM01 300 mg IV

RSM01 600 mg IM

Placebo

RSM01 300 mg IM

RSM01 1000 mg IV

RSM01 3000 mg IV

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

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