A Single-Center, 2-Part, Randomized, Double-Blind, Placebo Controlled, Single-Dose, Dose Escalation Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of AD-6626 Administered Intravenously to Normal, Healthy Volunteers (NHVs) Without Alcohol Administration in Part A and to NHVs and Subjects Heterozygous for the Aldehyde Dehydrogenase 21/2 Genetic Variant With Alcohol Administration in Part B

Aldea Pharmaceuticals0 个研究点目标入组 90 人开始时间: 2014年12月18日最近更新: 2020年1月13日

适应症

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•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

发起方

Aldea Pharmaceuticals