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

NCT06633562 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: NEZ-2021-012R44AA024905-064R44AA024905-07
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy; Safety Evaluation of Escalating Doses; Tolerability

Outcome Measures

Primary Outcomes (2)

• Safety, as measured by the severity, frequency, and relationship of adverse events (AEs) in participants

  Safety is assessed by collecting AEs, including changes from baseline of vital signs, physical examinations, electrocardiograms, fecal occult blood tests, gastrointestinal symptoms and stool consistency, Profile of Moods State (POMS), and clinical laboratory tests (chemistry, hematology, coagulation tests, pregnancy tests, and urinalysis). AEs will be assessed daily after the start of dosing, with closer evaluations in the 12-hour period after the start of dosing

  Serious AEs from the time of informed consent (all other AEs from dosing) through to the follow up visit, up to 7 days, unless serious or if the study physician assesses them to be clinically significant

• Maximum Tolerated Dose (MTD) of Nezavist in healthy volunteers

  The MTD is considered the highest dose where no participants who receive active study drug met the study stopping criteria

  From dosing through to the follow up visit, up to 7 days

Secondary Outcomes (6)

• Pharmacokinetics AUC-t

  From predose through clinic release on Day 3

• Pharmacokinetics AUC-infinity

  From predose through clinic release on Day 3

• Pharmacokinetics Cmax

  From predose through clinic release on Day 3

• Pharmacokinetics tmax

  From predose through clinic release on Day 3

• Pharmacokinetics λz

  From predose through clinic release on Day 3

Study Arms (5)

Nezavist Cohort 1

ACTIVE COMPARATOR

Nezavist 500 mg in a volume of 60 mL NPO 8 hrs AM bib.

Drug: Nezavist SDD

Nezavist Cohort 2

ACTIVE COMPARATOR

Nezavist 1500 mg in a volume of 60 mL NPO 8 hrs AM bib.

Drug: Nezavist SDD

Nezavist Cohort 3

EXPERIMENTAL

Nezavist 4500 mg in a volume of 60 mL NPO 8 hrs AM bib.

Drug: Nezavist SDD

Nezavist Cohort 4

EXPERIMENTAL

Nezavist 13500 mg in a volume of 60 mL NPO 8 hrs AM bib.

Drug: Nezavist SDD

Placebo

PLACEBO COMPARATOR

Placebo to match 5.4 g of Avicel in a volume of 60 mL NPO 8 hrs AM bib.

Drug: Placebo

Interventions

Nezavist SDD DRUG

Formulated as a spray dried dispersion (SDD) suspended in a flavored diluent.

Also known as: DCUK-OEt

Nezavist Cohort 1; Nezavist Cohort 2; Nezavist Cohort 3; Nezavist Cohort 4

Placebo DRUG

Formulated in a diluent that matches the Nezavist SDD suspension in appearance.

Also known as: Microcrystalline Cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female volunteer, aged 18-to-55 years-of-age, inclusive.
• BMI must be between 18 and 32 kg/m\^2 (inclusive) and weigh a minimum of 50 kg (110 lbs). BMI is calculated as weight in kg divided by the square of height measured in meters.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) at the screening visit.
• If female, be postmenopausal (at least 2 years prior to dosing) or agree to use an acceptable form of birth control from screening until 1 week after dosing. Subjects who claim postmenopausal status will have status confirmed with a follicle stimulating hormone (FSH) test. Acceptable forms of birth control for females include the following:
• Vasectomized partner (at least 6 months prior to dosing)
• Surgical sterilization (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) at least 6 months prior to dosing
• Non-surgical permanent sterilization (eg, Essure procedure) at least 3 months prior to dosing.
• Double barrier (diaphragm with spermicide; condoms with spermicide)
• Non-hormonal containing intrauterine device (IUD)
• Abstinence (must agree to use a double barrier method if they become sexually active during the study)
• If male, agree to use an acceptable method of birth control during the study and in the 1 week following dosing. Acceptable forms of birth control for males include the following:
• Vasectomy (at least 6 months before dosing)
• Partner is surgically sterilized (see methods above for females)
• Partner uses oral, injectable, or implantable hormonal contraceptives or IUD
• Double barrier (partner uses diaphragm with spermicide; condoms with spermicide)

You may not qualify if:

• History of significant sensitivity to any drug.
• Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis or use of any of the above within the 2 weeks or 5 half-lives of the respective medication prior to study drug administration.
• Not have reported taken any medications known to cause significant GI toxicity.
• More than moderate alcohol consumption in the past 8 weeks. Moderate alcohol consumption is defined as limiting intake to 2 drinks or less in a day for men and 1 drink or less per day for women. Examples of one drink include: Beer: 12 fluid ounces (355 milliliters); Wine: 5 fluid ounces (148 milliliters); Distilled spirits (80 proof): 1.5 fluid ounces (44 milliliters)
• Have a urine toxicology screen positive during screening or baseline for any of the following substances:
• benzodiazepines,
• cocaine,
• opioids,
• amphetamines,
• buprenorphine,
• methadone,
• methamphetamines
• oxycodone,
• tetrahydrocannabinol (THC)
• MDMA

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Lohocla Research Corporation: lead

Study Sites (1)

The Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Interventions

microcrystalline cellulose

Study Officials

• Mark Wallace, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All research staff will be blinded to treatment given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled, Single Site, Single Ascending Dose Study

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: February 28, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)