A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AD-6626 in Normal, Healthy Volunteers

Phase 1

Withdrawn

• Conditions: This study is for healthy volunteers. The intended use of the investigational product is the treatment of Fanconi Anemia; Blood - Haematological diseases; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12615000601538
• Lead Sponsor: Aldea Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 24

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.

Exclusion Criteria

- 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 16]

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of AD-6626 and its active metabolite as assessed through blood collection during the study[PK samples at the following timepoints<br>Day 0: within 5 minutes before Dose #1 and post Dose #1 at 15, 30, 45, 60, and 90 minutes and at 2, 3, 4, 6, 8, and 12 hours (before Dose #2).<br>- Days 1, 2, 3, 4, 5, and 7 (trough): within 5 minutes before the first dose each day.<br>- Day 9: within 5 minutes before Dose #19 and post Dose #19 at 15, 30, 45, 60, and 90 minutes and at 2,<br>3, 4, 6, 8, and 12 hours (before Dose #20).<br>- Day 10: at 12 and 24 hours post Dose #20.<br>- Day 11: at 36 and 48 hours post Dose #20.<br>- Day 12: at 72 hours post Dose #20.<br>- Day 16.]