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

Running, not enrolling · Phase 1 · Has a placebo group

Conditions studied: Healthy, Safety Evaluation of Escalating Doses, Tolerability

In brief

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).

Key facts

Study ID

NCT06633562

Run by

Lohocla Research Corporation

People needed

32

Starts

2025-02-28

Expected to finish

2027-05-01

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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)
• Abstinence (subject must agree to use a double barrier method if subject becomes sexually active during the study)
• Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English.
• Complete all assessments required at screening and baseline and be available to stay in the Phase I unit for a period of approximately 4-days and return for follow-up visits.
• Be someone who in the opinion of the investigator would be expected to complete the study protocol.

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
• Barbiturates
• ethyl glucuronide for recent alcohol use
• If female, positive pregnancy test or nursing.
• Positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
• Positive SARS-CoV-2 antigen test within 72-hours prior to clinic intake.
• Suspected or known history of Human Immunodeficiency Virus (HIV).
• History of any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, GI, hematologic, endocrine, dermatological, metabolic, neurological (nerve injury) or psychiatric disease or disorder, or any uncontrolled medical illness.
• History of gastric ulcers or known gastric sensitivity to non-steroidal anti-inflammatory drugs.
• Current symptoms of gastritis or potential GI ulcer complications or screening FOBT positive for blood in the stool.
• History of head trauma with loss of consciousness, history of epilepsy, seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.

Where it is running

• The Altman Clinical and Translational Research Institute — La Jolla, California, United States

Full record on ClinicalTrials.gov

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