AVR-48 for Safety Evaluation
What You Need to Know Before You Apply
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.
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.
Who Is on the Research Team?
Suchismita Acharya, PhD
Principal Investigator
AyuVis Research, Inc.
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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