A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of AD-6626 in Normal, Healthy Volunteers and Subjects Heterozygous for the Aldehyde Dehydrogenase 2*1/*2 Genetic Variant With and Without Alcohol Administratio
- Conditions
- This study is for healthy volunteers. The intended use of the investigational product is the treatment of acute alcohol intoxicationOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12614001333606
- Lead Sponsor
- Aldea Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
This study will be conducted in normal, healthy, adult, male or female aged between 21-45 years and with a BMI greater than or equal to 18 and less than or equal to 30. Eligible subjects will be in good health without signs or symptoms of current illness and with predose clinical and laboratory examinations without clinically significant findings. Subjects in Part A will be of non-Asian descent. Subjects in Part B Cohort 2 will be of Asian descent with the ALDH2*1/*2 (HeZ) genotype
- Homozygous for the ALDH2*2/*2 genotype
- History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of severe allergic or anaphylactic reactions
- Fever (body temperature >38 degrees celsius) or symptomatic viral or bacterial infection within 2 weeks prior to Screening
- Blood pressure (BP) >140/90 mm Hg or a heart rate (HR) >100 beats per minute at Screening and at Day -1
- Clinically significant laboratory abnormalities
- Female who is breastfeeding or has a positive pregnancy test at any visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequencies and types of AEs and SAEs through physical examination including vital signs, ECGs, pulse oximetry and safety laboratory tests[From the time of signed consent through the end of study date which occurs on Day 7 for both Part A and Part B of the study]
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of AD-6626 and its active metabolite as assessed through blood collection during the study[For both Part A and Part B, PK samples within 60 minutes before start of study drug infusion and post start of study drug infusion at 15, 30, 45, 60, 90, 120, 180, 240, and 300 minutes and 8 and 12 hours (Day 0); 24 and 36 hours (Day 1); 48 and 60 hours (Day 2); 72 hours (Day 3); and on Day 7]