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NCT06633562 · ClinicalTrials.gov registry record · Phase 1
A Study to Test the Effects of Nezavist at Different Doses in Healthy Adults
A Phase 1 study of Healthy and Tolerability, sponsored by Lohocla Research Corporation.
- Active
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT06633562: Active Phase 1 study of Healthy and Tolerability, sponsored by Lohocla Research Corporation.
NCT06633562 is a Phase 1 study of Healthy and Tolerability that is active but no longer recruiting, run by Lohocla Research Corporation. The registered enrollment target is 32 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06633562, a Phase 1 study of Healthy and Tolerability, is active but no longer recruiting, sponsored by Lohocla Research Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nezavist SDD
Study Locations (1)
California
- The Altman Clinical and Translational Research Institute - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2025-02-28 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 1 |
What the registry record for NCT06633562 still lists
NCT06633562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06633562 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06633562 about?
NCT06633562 is a clinical study titled "A Study to Test the Effects of Nezavist at Different Doses 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...
What is the current status of trial NCT06633562?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2025-02-28. Estimated completion is 2027-05-01.
What conditions does trial NCT06633562 study?
This clinical trial studies the following conditions: Healthy, Tolerability, Safety Evaluation of Escalating Doses.
What interventions are being tested in trial NCT06633562?
The interventions under investigation include: Placebo (DRUG), Nezavist SDD (DRUG).
Who is sponsoring clinical trial NCT06633562?
This trial is sponsored by Lohocla Research Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06633562 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06633562's enrollment target sits among peer trials
32 647th of 1090 higher than 418 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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