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NCT04273217 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers
A Phase 1 study, sponsored by AbViro.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT04273217: Completed Phase 1 study, sponsored by AbViro.
NCT04273217 is a Phase 1 study that has completed, run by AbViro. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04273217, a Phase 1 study, has completed, sponsored by AbViro.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
AV-1 is a human monoclonal antibody (mAb) being investigated as a potential therapy for dengue, a mosquito-borne viral disease with extensive global public health impact. Globally, over 2 billion people are thought to be at risk of infection from the dengue virus and there are an estimated 390 million infections each year. Current treatment options for dengue are limited to supportive care, so a safe and effective treatment would provide substantial public health benefits. AV-1 has not previously been tested in humans. This study aims to determine the safety of AV-1 in healthy adult volunteers, when administered as a single IV infusion. The results of the study are based on the clinical study report and statistical analysis plan.
Primary Outcome
Clinical laboratory abnormalities reported as TEAEs by the investigator. Clinical laboratory abnormalities were defined as any abnormal findings in analysis of hematology, serum chemistry, coagulation, and urine parameters. A TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure whether or not considered drug related.
Interventions
- DRUG Placebo
- DRUG AV-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2021-07-08 |
| Phase | Phase 1 |
What the finished NCT04273217 record still lists
NCT04273217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04273217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04273217 about?
NCT04273217 is a clinical study titled "A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers". AV-1 is a human monoclonal antibody (mAb) being investigated as a potential therapy for dengue, a mosquito-borne viral disease with extensive global public health impact. Globally, over 2 billion people are thought to be at risk of infection from the dengue virus and there are an estimated 390 milli...
What is the current status of trial NCT04273217?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2020-02-04. Estimated completion is 2021-07-08.
What interventions are being tested in trial NCT04273217?
The interventions under investigation include: Placebo (DRUG), AV-1 (DRUG).
Who is sponsoring clinical trial NCT04273217?
This trial is sponsored by AbViro, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04273217's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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