NCT06633562

A Study to Test the Effects of Nezavist at Different Doses in Healthy Adults

A Phase 1a Randomized, Double-blind, Placebo-controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Nezavist in Healthy Adults

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Lohocla Research Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

Eligible participants will undergo intake procedures and baseline evaluations at the clinic the day before dosing. The next day, participants will be randomized to, and receive, either Nezavist SDD oral suspension or placebo vehicle (4 cohorts of escalating doses of Nezavist with 6 Nezavist subjects and 2 placebo subjects in each cohort). Participants will remain in the clinic for at least an additional 48-hours for safety assessments and blood collections to determine plasma levels of Nezavist, then will be discharged from the clinic and return for follow-up safety tests 72-hours later.

Conditions

• Healthy
• Safety Evaluation of Escalating Doses
• Tolerability

Interventions

Type	Name	Description
DRUG	Nezavist SDD	Formulated as a spray dried dispersion (SDD) suspended in a flavored diluent.
DRUG	Placebo	Formulated in a diluent that matches the Nezavist SDD suspension in appearance.

Timeline

• Start date: 2025-02-28
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2024-10-09
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study