A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers
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.
Timeline
- Start
- 2020-02-04
- Primary completion
- 2021-07-08
- Completion
- 2021-07-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AV-1 | Monoclonal antibody | 30 mg | Intravenous |
| Subject | AV-1 | Monoclonal antibody | 90 mg | Intravenous |
| Subject | AV-1 | Monoclonal antibody | 250 mg | Intravenous |
| Subject | AV-1 | Monoclonal antibody | 500 mg | Intravenous |
| Subject | AV-1 | Monoclonal antibody | 1000 mg | Intravenous |
Indications
No indication recorded.