84 Participants Needed

AV-1 for Dengue Fever

Recruiting at 2 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

UR

Urban Ramstedt, PhD

Principal Investigator

AbViro LLC

Are You a Good Fit for This Trial?

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
My overall health is good based on recent medical exams.
See 4 more

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.
See 25 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • AV-1
Trial Overview 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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Group 3B treatmentExperimental Treatment2 Interventions
Group II: Group 3A prophylaxisExperimental Treatment2 Interventions
Group III: Group 2B treatmentExperimental Treatment2 Interventions
Group IV: Group 2A prophylaxisExperimental Treatment2 Interventions
Group V: Group 1B treatmentExperimental Treatment2 Interventions
Group VI: Group 1A prophylaxisExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbViro LLC

Lead Sponsor

Trials
2
Recruited
130+
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