← Back to Search

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 151 days
Awards & highlights

Study Summary

This trial is studying a potential RSV vaccine in healthy adults to see if it is safe and effective.

Eligible Conditions
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~151 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 151 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Solicited systemic AEs for 7 days after dose administration
Number of serious adverse events (SAEs) and AE of special interest (AESIs) through Day 151
Number of unsolicited adverse events (AEs) through Day 151
+1 more
Secondary outcome measures
Area under the capillary blood-concentration time curve from zero to infinity (AUC0-∞)
Cmax following IM administration and C0 following IV administration, Cmin
Day 151 capillary blood-concentration and area under the capillary blood-concentration time curve (CD151 and AUC0-D151)
+6 more
Other outcome measures
To characterize RSV neutralizing antibody activity following RSM01 administration

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RSM01Experimental Treatment1 Intervention
Participants will be randomized to receive different dose levels of RSM01. Participants will be randomized in a ratio of 6:1 where for every 6 participants receiving active drug (RSM01) 1 participant will receive Placebo.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebos 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
12 Previous Clinical Trials
32,143 Total Patients Enrolled
PPD Phase I Clinic - OrlandoUNKNOWN
Gates MRIStudy DirectorBill & Melinda Gates Medical Research Institute
8 Previous Clinical Trials
31,337 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies to be a participant in this clinical trial?

"This clinical trial is recruiting 56 persons suffering from respiratory syncytial virus between 18 and 49 years of age. To be eligible, they must be in good physical health, have a body mass index (BMI) ranging from 18 to 29.9 kg/m2, as well as agree to remain contactable by the study site across its duration and not relocate during this period. Women must ensure that they are not pregnant or breastfeeding for 28 days prior to their screening date and use contraception whilst taking part in the investigation until 90 days after it concludes; male participants with partners of childbearing potential must follow these same guidelines regarding contraceptives too"

Answered by AI

What potential hazards do patients face when exposed to RSM01?

"Our team has assigned RSM01 a score of 1 because this is the initial stage of clinical trials and so far only limited data exists for its safety and efficacy."

Answered by AI

What is the capacity of this medical research project?

"Correct. The clinical trial is actively recruiting, as outlined on the clinicaltrials.gov website. First posted on November 11th 2021, this study seeks 56 participants from a single location and was last edited October 13th 2022."

Answered by AI

Is the age requirement for this trial inclusive of those 45 and older?

"This research project has imposed age limits of 18 years and below 49 for inclusion in the study."

Answered by AI

What are the essential aims of this clinical investigation?

"This 151-day trial aims to evaluate the number of systemic adverse events that arise within a 7 day period following medication administration. Secondary goals include determining area under the capillary blood concentration curve over time, tracking safety labs parameters, and measuring peak concentrations in capillary blood on Day 91."

Answered by AI

Is this study actively seeking participants?

"Clinicaltrials.gov shows that this study is actively recruiting participants. The trial first appeared on November 11th 2021 and its most recent update was October 13th 2022."

Answered by AI
~16 spots leftby Apr 2025