HealthyPhase 1NCT06633562
A Study to Test the Effects of Nezavist at Different Doses in Healthy Adults
A Phase 1 study testing Nezavist SDD in people with Healthy and Safety Evaluation of Escalating Doses, run by Lohocla Research Corporation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Safety Evaluation of Escalating Doses, Tolerability
- What is being tested?
- Nezavist SDD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to 22 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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,
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- 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.
- Use of any known strong CYP3A4 inhibitors (e.g., ketoconazole) or dual CYP3A4 and 2C9 inhibitor (eg. fluconazole), or dual CYP3A4 and 2C9 inducer (eg. rifampin), or use of any monoamine oxidase inhibitors (MAOIs) within 1 month prior to study drug administration.
- A clinically notable vital sign abnormality including a history of syncopal or near syncopal events following abrupt change in posture.
- Have any of the following at screening or baseline:
- Blood pressure: systolic greater than140 mmHg, diastolic greater than 90 mmHg at Screening or Day -1.
- Heart rate: greater than 100 beats/minute at screening or Day -1
- Has a clinically significant laboratory test that is greater than 20% of the upper and lower limit of normal. An out of range normal limit laboratory value is clinically significant if associated with one of the following: a) clinical diagnosis; b) systemic signs and symptoms; or c) physical exam finding.
- History of cardiac disease, including family history of long-QT syndrome, second degree heart block Type II, third degree heart block or unexplained sudden deaths in their family.
- Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) greater than 430 msec.
- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with GI motility, pH or absorption.
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.
- Receipt of any investigational product within 6 weeks prior to study drug administration.
- Consumption of alcohol within the 1-day period prior to study drug administration
- Consumption of grapefruit or grapefruit products from 3 days prior to study drug administration to study drug administration.
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
- Current enrollment in another clinical study.
- Previous enrollment in this study resulting in administration of nezavist or placebo.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive nezavist.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Altman Clinical and Translational Research Institute
La Jolla, California, 92037
About this study
Official title: 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
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).
Read the 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
- Being tested
- Nezavist SDD, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nezavist SDDDrug
Also called DCUK-OEt
Formulated as a spray dried dispersion (SDD) suspended in a flavored diluent.
PlaceboDrug
Also called Microcrystalline Cellulose
Formulated in a diluent that matches the Nezavist SDD suspension in appearance.
| Study group | Role | What they receive |
|---|---|---|
| Nezavist Cohort 1 | Active comparator | Nezavist 500 mg in a volume of 60 mL NPO 8 hrs AM bib. Receives: Drug: Nezavist SDD |
| Nezavist Cohort 2 | Active comparator | Nezavist 1500 mg in a volume of 60 mL NPO 8 hrs AM bib. Receives: Drug: Nezavist SDD |
| Nezavist Cohort 3 | Experimental | Nezavist 4500 mg in a volume of 60 mL NPO 8 hrs AM bib. Receives: Drug: Nezavist SDD |
| Nezavist Cohort 4 | Experimental | Nezavist 13500 mg in a volume of 60 mL NPO 8 hrs AM bib. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From dosing through to the follow up visit, up to 7 days
Secondary outcomes (6)
Pharmacokinetics AUC-t
Area under the plasma concentration-time curve from time 0 to the time (t) of last quantifiable concentration (Ct) calculated by the log-linear trapezoidal rule
Measured: From predose through clinic release on Day 3
Pharmacokinetics AUC-infinity
Area under the plasma concentration-time curve from time 0 extrapolated to infinity. The terminal area from Ct to infinity is calculated by using the approximation as Ct/λz thus AUC∞ = AUCt + Ct/λz
Measured: From predose through clinic release on Day 3
Pharmacokinetics Cmax
The maximum observed plasma concentration
Measured: From predose through clinic release on Day 3
Pharmacokinetics tmax
The observed time to reach the maximum plasma concentration
Measured: From predose through clinic release on Day 3
Pharmacokinetics λz
The terminal-phase exponential rate constant as calculated from the negative slope of the regression line for the terminal linear portion of the natural log (ln) transformed plasma concentration versus time curve
Measured: From predose through clinic release on Day 3
Pharmacokinetics t1/2
The apparent terminal exponential half-life, calculated as ln(2)/λz
Measured: From predose through clinic release on Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start28 Feb 2025
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Why it stopped: The trial was terminated early due to regulatory constraints preventing the continuation of study conduct.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo-controlled, Single Site, Single Ascending Dose Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lohocla Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Mark Wallace, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633562
- Sponsor's protocol ID
- NEZ-2021-01
- Other IDs
- 2R44AA024905-06, 4R44AA024905-07
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06633562
- Acronym / sponsor ID
- NEZ-2021-01
- Conditions
- Healthy, Safety Evaluation of Escalating Doses, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated early due to regulatory constraints preventing the continuation of study conduct.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Lohocla Research CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized, Double-blind, Placebo-controlled, Single Site, Single Ascending Dose Study
| Arm | Type | Receives |
|---|---|---|
| Nezavist Cohort 1 | Active comparator | Drug: Nezavist SDDNezavist 500 mg in a volume of 60 mL NPO 8 hrs AM bib. |
| Nezavist Cohort 2 | Active comparator | Drug: Nezavist SDDNezavist 1500 mg in a volume of 60 mL NPO 8 hrs AM bib. |
| Nezavist Cohort 3 | Experimental | Drug: Nezavist SDDNezavist 4500 mg in a volume of 60 mL NPO 8 hrs AM bib. |
| Nezavist Cohort 4 | Experimental | Drug: Nezavist SDDNezavist 13500 mg in a volume of 60 mL NPO 8 hrs AM bib. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match 5.4 g of Avicel in a volume of 60 mL NPO 8 hrs AM bib. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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:
- 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:
Key exclusion criteria (42 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nezavist SDDAlso: DCUK-OEtFormulated as a spray dried dispersion (SDD) suspended in a flavored diluent. | Drug | Nezavist Cohort 1, Nezavist Cohort 2, Nezavist Cohort 3, Nezavist Cohort 4 |
| PlaceboAlso: Microcrystalline CelluloseFormulated in a diluent that matches the Nezavist SDD suspension in appearance. | Drug | Placebo |
Primary outcome
Safety, as measured by the severity, frequency, and relationship of adverse events (AEs) in participants
Time frame: 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
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
Maximum Tolerated Dose (MTD) of Nezavist in healthy volunteers
Time frame: From dosing through to the follow up visit, up to 7 days
The MTD is considered the highest dose where no participants who receive active study drug met the study stopping criteria
6 secondary outcomes
Pharmacokinetics AUC-t
Time frame: From predose through clinic release on Day 3
Pharmacokinetics AUC-infinity
Time frame: From predose through clinic release on Day 3
Pharmacokinetics Cmax
Time frame: From predose through clinic release on Day 3
Pharmacokinetics tmax
Time frame: From predose through clinic release on Day 3
Pharmacokinetics λz
Time frame: From predose through clinic release on Day 3
Pharmacokinetics t1/2
Time frame: From predose through clinic release on Day 3
Results and safety
The study was stopped early (reason given: The trial was terminated early due to regulatory constraints preventing the continuation of study conduct.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Wallace, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nezavist SDD in people with Healthy and Safety Evaluation of Escalating Doses, run by Lohocla Research Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial was terminated early due to regulatory constraints preventing the continuation of study conduct.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, as measured by the severity, frequency, and relationship of adverse events (AEs) in participants (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.