ACTRN12615000601538WithdrawnPhase 1
A Single-Center, Randomized, Double-Blind, Placebo Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of AD 6626 Administered Orally to Normal, Healthy Volunteers
Aldea Pharmaceuticals0 sites24 target enrollmentStarted: June 9, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 21 Years to 45 Years (—)
- Sex
- All
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
Investigators
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