A Single-Center, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Single-dose, Dose Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of a Single Dose of AD-6626 Administered Orally to Normal, Healthy Volunteers in Part A and the Safety/Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of a Single Oral Dose of AD-6626 Followed by Alcohol Administration in Normal, Healthy Volunteers With the Aldehyde Dehydrogenase 2 (ALDH2)1/1 (Wild Type) or ALDH21/2 (Heterozygous) Genetic Variant in Part B

ucleus Network0 个研究点目标入组 64 人开始时间: 2015年1月22日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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 will be of Asian or non-Asian descent with ALDH2*1/*2 (HeZ) or ALDH2*1/*1 (WT) genotype, respectively

•- 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

ucleus Network