AV-1 for Dengue Fever

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AbViro LLC

Must not be taking: Antidepressants, Immunosuppressants, NSAIDs, others

Disqualifiers: Alcoholism, Drug abuse, Hepatitis, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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)

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that certain medications are prohibited. These include oral/systemic anti-neoplastic agents, medications that alter drug absorption, metabolism, or elimination, immunosuppressive drugs, aspirin products, and NSAIDs. It's best to discuss your current medications with the trial team to see if they are allowed.

Eligibility Criteria

This trial is for healthy adults who can potentially be exposed to Dengue Virus 3 (DENV-3). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.

Inclusion Criteria

Body mass index between 18.5 and 34.9 kg/m², inclusive, at Screening

12-lead electrocardiogram (ECG) and clinical laboratory evaluations within normal range at screening

I am between 18 and 55 years old and not pregnant or breastfeeding.

Exclusion Criteria

History of anaphylaxis to any drug compound, food, or other substance, unless approved by the investigator

I have not had major surgery in the last 3 months.

I haven't taken aspirin in the week before the study starts and won't for 14 days after.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prophylaxis

Participants receive AV-1 for prophylactic effect against DENV-3

4 weeks

Treatment

Participants receive AV-1 for therapeutic effect against DENV-3

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

22 weeks

Participant Groups

The study tests the safety and effectiveness of AV-1 at different doses (100 mg, 300 mg, and 900 mg) compared to a placebo in preventing or treating DENV-3 infection using a controlled human infection model.

Group I: Group 3B treatment Experimental Treatment 2 Interventions

Group II: Group 3A prophylaxis Experimental Treatment 2 Interventions

Group III: Group 2B treatment Experimental Treatment 2 Interventions

Group IV: Group 2A prophylaxis Experimental Treatment 2 Interventions

Group V: Group 1B treatment Experimental Treatment 2 Interventions

Group VI: Group 1A prophylaxis Experimental Treatment 2 Interventions

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Center for Immunization Research (CIR) JHBSPH Baltimore, MD

Center for Immunization Research Inpatient Unit Baltimore, MD

UVM Larner College of Medicine Department of MMG Burlington, VT

Who Is Running the Clinical Trial?

AbViro LLC Lead Sponsor

References