Phase 2
N=26
A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels
Ethanol Intoxication
Bottom Line
View on ClinicalTrials.gov: NCT05487404 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Subjects With Serious Adverse Events — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ADX-629 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Aldeyra Therapeutics, Inc.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serious Adverse Events |
0; 0 | — |
| SECONDARY Change From Baseline of Dermal Flushing |
-4.02; 1.15 | — |
| SECONDARY Change From Baseline for Romberg Test |
-0.04; -1.42 | — |
Summary
A Double-Blind Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between the ages of 21 and 65 years, inclusive, at Screening;
- Subjects with the ability to obtain transportation to and from the study site;
- Subjects who agree to abstain from consumption of non-study alcohol during the study.
Exclusion Criteria
- Subjects with abnormal laboratory values of clinical significance, at the discretion of the Investigator, at Screening;
- Subjects with nicotine product use within 14 days prior to Screening until the end of the study;
- Subjects with any history of or current alcohol or other substance use disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition;
- Subjects with a positive urine drug screen or breath alcohol test at Screening or Check-In (both treatment periods).
Data sourced from ClinicalTrials.gov (NCT05487404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.