Nezavist for Safety Evaluation
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 safety, tolerability and effects of Nezavist in healthy adults. The main questions it aims to answer are:* What is the safety and maximum tolerated dose (MTD) of orally administered Nezavist formulated as a spray dried dispersion (SDD) in healthy volunteers?* What are the pharmacokinetics (PK) of orally administered Nezavist SDD and its major metabolite (DCUKA) across a range of doses in healthy volunteers?Researchers will compare the active drug (Nezavist) and a placebo (an inactive substance that looks like the drug) to see if there is any differences between the two groups to make sure Nezavist is safe to use in future studies for reducing alcohol consumption by individuals that have alcohol use disorder (AUD).
Will I have to stop taking my current medications?
Yes, participants must stop taking any over-the-counter or prescription medications, vitamins, and herbal supplements at least 2 weeks before the study drug is given.
Who Is on the Research Team?
Mark Wallace, MD
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for healthy adults who can safely participate in a study to determine the safety and tolerability of Nezavist, an experimental drug. Participants must meet specific health requirements but detailed inclusion and exclusion criteria are not provided.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nezavist SDD oral suspension or placebo and remain in the clinic for safety assessments and blood collections
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nezavist
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lohocla Research Corporation
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator