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NCT05118386 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults
A Phase 1 study, sponsored by Gates Medical Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT05118386 is a Phase 1 study that has completed, run by Gates Medical Research Institute. The registered enrollment target is 56 participants.
The verdict
NCT05118386, a Phase 1 study, has completed, sponsored by Gates Medical Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG RSM01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2021-11-16 |
| Est. Completion | 2022-12-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05118386
The ClinicalTrials.gov registry entry for NCT05118386 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gates Medical Research Institute, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05118386 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05118386 about?
NCT05118386 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults". 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 ...
What is the current status of trial NCT05118386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2021-11-16. Estimated completion is 2022-12-07.
What interventions are being tested in trial NCT05118386?
The interventions under investigation include: Placebo (OTHER), RSM01 (DRUG).
Who is sponsoring clinical trial NCT05118386?
This trial is sponsored by Gates Medical Research Institute, which has 6 total clinical trials registered on ClinicalTrials.gov.
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