AVR-48 for Safety Evaluation
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription or non-prescription medications, herbal remedies, or vitamin supplements starting 14 days before the first dose and throughout the study. However, acetaminophen (up to 2 grams per day) and hormone replacement therapy are allowed.
What is the purpose of this trial?
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.
Research Team
Suchismita Acharya, PhD
Principal Investigator
AyuVis Research, Inc.
Eligibility Criteria
This trial is for healthy adult volunteers interested in testing a new medication, AVR-48. Participants must meet certain health standards but specific inclusion and exclusion criteria are not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD)
Participants receive a single IV dose of AVR-48 or placebo in a sentinel dosing design
Multiple Ascending Dose (MAD)
Participants receive multiple IV doses of AVR-48 or placebo over 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AVR-48
Find a Clinic Near You
Who Is Running the Clinical Trial?
AyuVis Research, Inc.
Lead Sponsor
National Institutes of Health (NIH)
Collaborator