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NCT04737486 · ClinicalTrials.gov registry record · Phase 1
A First-in-Human Study of AV-001 in Healthy Subjects
A Phase 1 study, sponsored by Vasomune Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT04737486: Completed Phase 1 study, sponsored by Vasomune Therapeutics.
NCT04737486 is a Phase 1 study that has completed, run by Vasomune Therapeutics. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04737486, a Phase 1 study, has completed, sponsored by Vasomune Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
Phase 1 randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) first-in-human study in healthy subjects. Safety and tolerability assessments will be conducted, and blood samples will be taken pre-dose and at several time points post-dose for pharmacokinetic (PK) and pharmacodynamics (PD) analysis.
Primary Outcome
Number of drug-related adverse events as determined by abnormal clinical laboratory tests, vitals signs, continuous blood pressure monitoring and collection (systolic, diastolic, pulse pressure, heart rate and mean arterial pressure), physical exam and ECG parameters
Interventions
- OTHER Placebo
- DRUG AV-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-12-16 |
| Est. Completion | 2021-03-10 |
| Phase | Phase 1 |
What the finished NCT04737486 record still lists
NCT04737486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04737486 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04737486 about?
NCT04737486 is a clinical study titled "A First-in-Human Study of AV-001 in Healthy Subjects". Phase 1 randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) first-in-human study in healthy subjects. Safety and tolerability assessments will be conducted, and blood samples will be taken pre-dose and at several time points post-dose for pharma...
What is the current status of trial NCT04737486?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2020-12-16. Estimated completion is 2021-03-10.
What interventions are being tested in trial NCT04737486?
The interventions under investigation include: Placebo (OTHER), AV-001 (DRUG).
Who is sponsoring clinical trial NCT04737486?
This trial is sponsored by Vasomune Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04737486's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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