Nezavist for Safety Evaluation

Overseen By Administrative Assistant

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Lohocla Research Corporation

Must not be taking: CYP3A4 inhibitors, MAOIs

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

Compensation: Varies

Number of Visits: 2

Duration: 3 days

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new treatment called Nezavist in healthy adults. It examines how the body processes Nezavist when taken orally and identifies the safest maximum dose. Researchers compare Nezavist to a placebo to ensure its safety for future studies that might help reduce alcohol consumption in people with alcohol use disorder. Ideal participants are healthy adults who rarely drink alcohol, adhering to moderate drinking guidelines. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that Nezavist is likely to be safe for humans?

Research has shown that Nezavist has been studied for its safety and tolerability. Nezavist is being tested to help individuals with alcohol use disorder by reducing the likelihood of relapse. Although specific human safety data is not yet available, this trial is in its early stages, and researchers are still determining safety details.

Earlier studies with animals showed that Nezavist reduced alcohol relapse without major safety issues. While this is encouraging, it is important to remember that what is safe for animals may not be safe for humans. This study aims to determine the safest dose and how the drug functions in the body.

The trial includes various dose groups, ranging from low to high, to identify the safest dose. This approach helps detect any side effects early. If Nezavist is well-tolerated at these doses, it will be a promising step toward future studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Nezavist is unique because it explores a range of dosage levels, from 500 mg to a whopping 13,500 mg, which could provide insights into optimal dosing that balances efficacy and safety. Unlike standard treatments that typically focus on a single dosage, Nezavist’s varied cohorts allow researchers to fine-tune its effects more precisely. Researchers are particularly excited about its novel active ingredient, Nezavist, which may offer a new mechanism of action compared to existing options. This potential for a new approach to treatment is what makes Nezavist stand out in the landscape of current therapies.

What evidence suggests that Nezavist might be an effective treatment for alcohol use disorder?

Research has shown that Nezavist is a promising treatment aimed at helping people with Alcohol Use Disorder (AUD) reduce their drinking. It targets specific brain changes caused by long-term alcohol use, which can help prevent relapse. In this trial, participants will receive varying dosages of Nezavist or a placebo to evaluate its safety and effectiveness. Although Nezavist is still under investigation, early studies suggest it addresses these brain changes linked to addiction, making it a potential tool for those struggling with AUD. More research is needed to fully confirm its benefits, but the initial findings are hopeful. ^{1 2 3 4 6}

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

2. 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.

3. 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.

* Vasectomized partner (at least 6 months prior to dosing)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive Nezavist SDD oral suspension or placebo and remain in the clinic for safety assessments and blood collections

3 days

Continuous stay (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Nezavist

Trial Overview The trial tests different doses of Nezavist, given orally as a spray dried dispersion (SDD), against a placebo. It aims to find out the maximum tolerated dose and how the body processes the drug and its main metabolite.

How Is the Trial Designed?

Group I: Nezavist Cohort 4 Experimental Treatment 1 Intervention

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

Group II: Nezavist Cohort 3 Experimental Treatment 1 Intervention

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

Group III: Nezavist Cohort 1 Active Control 1 Intervention

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

Group IV: Nezavist Cohort 2 Active Control 1 Intervention

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

Group V: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Lohocla Research Corporation

Lead Sponsor

Trials

2

Recruited

60+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

The term 'adverse events' is the most commonly used in medical literature to describe negative outcomes related to healthcare, highlighting its importance in patient safety research.

The primary focus of adverse events research is to understand these events as outcomes, with data primarily sourced from patient clinical records and self-reports by healthcare professionals, indicating a need for more comprehensive studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in acute care: an integrative literature review. Kellogg, VA., Havens, DS.[2022]

The study developed an automated method to aggregate various sources of drug safety information, achieving high predictive accuracy (≥0.92) in classifying drug-adverse event relationships, which can significantly streamline the process of identifying drugs associated with adverse reactions.

This approach offers a scalable alternative to the traditional manual curation methods, potentially saving time and resources in drug safety research by efficiently creating reference sets of drugs that do or do not cause adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of an automated knowledge base for identifying drug adverse reactions. Voss, EA., Boyce, RD., Ryan, PB., et al.[2019]

A systematic review of 108 adverse drug event (ADE) reporting systems revealed 1782 unique data fields, highlighting significant variability in how ADEs are reported, which complicates data comparison and aggregation across different systems.

Despite consistent reporting concepts, the lack of standardized terminology and the use of multiple drug and disease dictionaries hinder effective drug safety monitoring, suggesting a need for a common standardized dataset to improve ADE reporting and surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug event reporting systems: a systematic review. Bailey, C., Peddie, D., Wickham, ME., et al.[2021]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

The SMART Safety dataset is the largest collection of empirical data on adverse events in healthcare, comprising 151 systematic reviews and 629 meta-analyses, which enhances the understanding of safety outcomes in randomized controlled trials.

This dataset, which includes over 2,300 trials and 362 harm outcomes, has been rigorously validated to ensure high data quality, providing a valuable resource for addressing rare adverse events and biases in evidence synthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SMART Safety: An empirical dataset for evidence synthesis of adverse events. Fan, S., Yu, T., Yang, X., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06633562

NCT06633562 | A Study to Test the Effects of Nezavist at ... 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 ...

2. withpower.com withpower.com/trial/phase-1-tolerability-2025-25292

Nezavist for Safety Evaluation What safety data exists for Nezavist or similar treatments? The research articles discuss general drug safety data, adverse drug event reporting, and ...

3. reporter.nih.gov reporter.nih.gov/search/ZtELkzGuXUKiHewOS-8x9Q/project-details/11124195

Nezavist a Novel Molecule for Treatment of Alcohol Use ... According to the 2019 National Survey on Drug Use and Health, 14.1 million adults ages 18 and older had Alcohol Use Disorder, and approximately 825,000 ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-1-to-test-effects-nezavist-different-doses-healthy-adults-trial-nct06633562

A Study to Test the Effects of Nezavist At Different Doses ... This Interventional study is looking for people with Healthy, Safety Evaluation of Escalating Doses in La Jolla United States to take part.

5. lohocla.org lohocla.org/research/pipeline/nezavist.php

Nezavist® Lohocla Research designed Nezavist to target these neuroadaptive changes and reduce relapse drinking. Lohocla Research has received clearance from the FDA to ...

6. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT06633562

Nezavist SDD in Tolerability and Safety Evaluation of Escalating ... 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 ...