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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AD-6626 in Normal, Healthy Volunteers and Subjects Heterozygous for the Aldehyde Dehydrogenase 2*1/*2 Genetic Variant With and Without Alcohol Administration
Scientific title
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 ALDH2*1/*2 (Heterozygous) Genetic Variant in Part B
Secondary ID [1] 285896 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This study is for healthy volunteers. The intended use of the investigational product is the treatment of Fanconi Anemia 293819 0
Condition category
Condition code
Human Genetics and Inherited Disorders 294122 294122 0 0
Other human genetics and inherited disorders
Blood 294240 294240 0 0
Haematological diseases

Study type
Description of intervention(s) / exposure
Part A consists of sequential dose escalation with approximately 5 cohorts of subjects (8 subjects per cohort) given a single oral dose of AD-6626 or placebo. The doses of AD-6626 are 100mg, 300mg, 600mg, 1200mg and 1200mg with food.
Part B is a two period crossover of single oral administration of AD-6626 or placebo following oral EtOH administration in NHVs or subjects with the ALDH2*1/*2 (HeZ) genotype. A total of 24 subjects will be dosed. The dose of AD-6626 will be determined from Part A of the study. The oral EtOH dose will be 0.75 gm/kg for NHVs and 0.5 gm/kg for subjects with the ALDH2*1/*2 genotype. The AD-6626 will be given 30 minutes before the oral dose of EtOH. There will be 7 days between the treatments in Part B
Intervention code [1] 290878 0
Treatment: Drugs
Comparator / control treatment
Placebo which is cranberry juice delivered as an oral solution
Control group

Primary outcome [1] 293924 0
Frequencies and types of AEs and SAEs through physical examination including vital signs, ECGs, pulse oximetry and safety laboratory tests
Timepoint [1] 293924 0
From the time of signed consent through the end of study date which occurs on Day 7 for Part A and Day 7 of Period 2 for Part B of the study
Secondary outcome [1] 312155 0
Pharmacokinetics of AD-6626 and its active metabolite as assessed through blood collection during the study
Timepoint [1] 312155 0
For both Part A and Part B, PK samples within 60 minutes before dosing and postdose 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 (EOS).

Key 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 will be of Asian or non-Asian descent with ALDH2*1/*2 (HeZ) or ALDH2*1/*1 (WT) genotype, respectively
Minimum age
21 Years
Maximum age
45 Years
Both males and females
Can healthy volunteers participate?
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 290481 0
Commercial sector/Industry
Name [1] 290481 0
Aldea Pharmaceuticals
Address [1] 290481 0
3696 Haven Avenue, Suite C
Redwood City, CA 94063
Country [1] 290481 0
United States of America
Primary sponsor type
Commercial sector/Industry
Nucleus Network
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Victoria, 3004
Secondary sponsor category [1] 289184 0
Commercial sector/Industry
Name [1] 289184 0
Aldea Pharmaceuticals
Address [1] 289184 0
3696 Haven Avenue, Suite C
Redwood City, CA 94063
Country [1] 289184 0
United States of America

Ethics approval
Ethics application status

Brief summary
The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of oral 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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 53734 0
Dr Jason Lickliter, MBBS PhD FRACP
Address 53734 0
Nucleus Network Limited Level 5 Burnet Institute AMREP Precinct 89 Commercial Road Melbourne Victoria 3004
Country 53734 0
Phone 53734 0
+61 3 9076 8960
Fax 53734 0
Email 53734 0
Contact person for public queries
Name 53735 0
Dr Jason Lickliter, MBBS PhD FRACP
Address 53735 0
Nucleus Network Limited Level 5 Burnet Institute AMREP Precinct 89 Commercial Road Melbourne Victoria 3004
Country 53735 0
Phone 53735 0
+61 3 9076 8960
Fax 53735 0
Email 53735 0
Contact person for scientific queries
Name 53736 0
Dr Richard Shames
Address 53736 0
ALDEA Pharmaceuticals 3696 Haven Avenue, Suite C Redwood City, CA 94063
Country 53736 0
United States of America
Phone 53736 0
+1 650-575-0798
Fax 53736 0
Email 53736 0

No information has been provided regarding IPD availability
Summary results
No Results