A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of AD-6626 in Normal, Healthy Volunteers and Subjects Heterozygous for the Aldehyde Dehydrogenase 21/2 Genetic Variant With and Without Alcohol Administration

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 2*1/*2 Genetic Variant With Alcohol Administration in Part B

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001333606

Enrollment

Registered

2014-12-18

Start date

2014-12-18

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of AD-6626 without and without alcohol administration in normal healthy volunteers and subjects heterozygous (HeZ) for the aldehyde dehydrogenase 2 (ALDH2)*1/*2 genetic variant

Interventions

Part A consists of sequential dose escalation with approximately 3 cohorts of subjects (8 subjects per cohort) given an intravenous dose of AD-6626 or placebo and 12 additional subjects given the dose of AD-6626 below the MTD. The doses of AD-6626 are 100mg, 300mg and 750mg. Part B consists of single intravenous administration of AD-6626 or placebo following oral EtOH administration in NHVs or subjects with the ALDH2*1/*2 (HeZ) genotype. The dose of AD-6626 will be determined from Part A of the study. The oral EtOH dose will be 0.75 gm/kg or 0.5 gm/kg. The AD-6626 will be given 10 minutes after the oral dose of EtOH. Part B will include a cohort of NHVs from Part A who will receive either AD-6626 or placebo according to their Part A treatment assignments.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

21 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

- 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

Outcome results