A Study to Evaluate the Safety and Efficacy of AV-1 Against Dengue Virus 3 (DENV-3) Infection (NCT06799741) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety and Efficacy of AV-1 Against Dengue Virus 3 (DENV-3) Infection
United States85 participantsStarted 2025-01-07
Plain-language summary
The goal of this clinical trial is to determine the prophylactic and therapeutic effect of AV-1 in healthy adults using a DENV-3 controlled human infection model (CHIM)
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. QTcF \>450 ms in men or \>460 ms in women
✓. PR \>220 ms ventricular or atrial premature contractions in couplets or higher in grouping
✓. Complete left or right bundle branch block
✓. 2nd or 3rd degree atrioventricular block
✓. Sustained ventricular or atrial arrhythmia
✓. ST elevation consistent with cardiac ischemia
✓. Potential subjects with non-clinical sinus arrhythmia could be included in the study
✓. Reliable methods of contraception include: long acting, reversible contraception (LARC), hormonal birth control\* (implantable device, hormonal patch, hormonal vaginal ring, oral contraception, Depo-Provera injection, etc.), surgical sterilization (hysterectomy, tubal ligation, or tubal coil at least 90 days prior to Investigational Product \[IP\] dosing)