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Antizol · 1 trial · 1 indication
AEs were collected to evaluate the safety and tolerability of oral Antizol with concomitant ethanol administration in particitpants with symptoms of acetaldehyde toxicity associated with altered ethanol metabolism. AE: any untoward medical event that occurs following the first administration of study medication until the study participant's last study visit, whether or not the event is considered drug related. SAE: an event that meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of an exposed subject; is medically significant or an important medical event as assessed by investigator or sponsor; is, in the opinion of the investigator, an important medical event.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Antizol 1.0 mg/kg | EXPERIMENTAL | Participants receive alternating study treatment (oral fomepizole 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. |
| Cohort 2: Antizol 3.0 mg/kg | EXPERIMENTAL | Participants receive alternating study treatment (oral fomepizole 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. |
| Cohort 3: Antizol 5.0 mg/kg | EXPERIMENTAL | Participants receive alternating study treatment (oral fomepizole 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol. |
| Cohort 4: Antizol 1.0 mg/kg | EXPERIMENTAL | Participants receive alternating study treatment (oral fomepizole 7.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol. |
| Name | Type | Description |
|---|---|---|
| Antizol | DRUG | - |
| Placebo | DRUG | - |
| Ethanol | OTHER | oral dose of ethanol (0.5 g/kg) |
Inclusion Criteria: * Signed informed consent * Age 21 to 50 years * Subject of Japanese descent * History of flushing, with or without palpitations, or nausea (Alcohol Sensitivity Screening Test ≥ 3.1) following occasional or inadvertent ethanol consumption either currently or in the past * Subjec...
Antizol is an investigational small molecule being studied for use in Aldehyde Dehydrogenase-2 (ALDH2) Deficiency, a rare condition that impairs the body's ability to break down acetaldehyde after alcohol consumption. It is not approved and remains in clinical development for this indication.
Antizol targets the enzyme aldehyde dehydrogenase-2 (ALDH2). By interacting with this enzyme, it is intended to address the acetaldehyde toxicity that occurs in individuals with ALDH2 deficiency after ethanol exposure. This mechanism is the basis for its investigational use in this rare disease.
Antizol is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical research to evaluate the drug's safety and efficacy for the treatment of ALDH2 deficiency.
Antizol is in Phase 2 clinical development. It has completed one Phase 2a trial, and it remains an investigational drug that has not received FDA approval. The drug is still being studied to determine its potential as a treatment for ALDH2 deficiency.
Antizol has one completed clinical trial, NCT00661141, a Phase 2a study titled 'Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism.' This randomized, double-blind, controlled trial enrolled 32 participants in the United States and included healthy volunteers.
Yes, Antizol is the same as fomepizole. The completed Phase 2a clinical trial NCT00661141 specifically evaluated fomepizole, which is the active ingredient in Antizol, for its effects on acetaldehyde toxicity in subjects with altered ethanol metabolism due to ALDH2 deficiency.