Phase 1a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of AKB 4924 in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- AKB-4924
- Conditions
- IBD
- Sponsor
- Aerpio Therapeutics
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Single ascending dose (SAD): Safety and tolerability of AKB-4924
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I study in healthy male subjects.
Detailed Description
Single oral doses of AKB-4924 will be investigated in up to 6 sequential cohorts of 8 healthy male subjects. Primarily 6 dose levels are planned; the proposed doses are 20 mg, 60 mg, 120 mg, 240 mg, 360 mg, and 480 mg. Actual doses may be decreased or increased based on the safety and tolerability of the drug, as determined by the Investigator and Sponsor. Additional cohorts may be added as needed to test lower, higher, or repeat doses.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male subjects between 18 to 49 years of age, inclusive.
- •Body mass index (BMI) between 18 to 30 kg/m2, inclusive.
- •Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Exclusion Criteria
- •Non-vasectomized male subjects and their female partners who are unable or unwilling to use an acceptable method of contraception (as described in Section 8.1.3, Contraception and Pregnancy Avoidance Measures) during the study and for 30 days following the last dose of study medication.
- •Evidence of active infection, unless the medical monitor and Investigator agree that the subject is appropriate for this study.
- •Current or past history of chronic disease including, but not limited to, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, neurologic, renal, or liver disease.
- •Diastolic blood pressure ≤55 mmHg or systolic blood pressure ≤100 mmHg at Screening.
- •Clinically important or significant conduction abnormalities on ECG at Screening (including QTcF intervals \>450 msec) and/or history of long QT syndrome. It is acceptable to repeat the ECG to confirm findings.
- •Any history of malignancy in the previous 5 years except for curatively resected basal cell carcinoma of skin or squamous cell carcinoma of skin, or resected benign colonic polyps.
- •Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibodies.
- •Serum transaminase (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) levels \>1.5X the upper limit of normal (ULN). If a subject presents with an abnormal AST and/or ALT results, the subject may be re-scheduled or the test may be repeated once at the discretion of the Investigator.
- •Serum creatinine level ≥1.50 mg/dL. It is acceptable to repeat the test to confirm findings.
- •Chronic daily medication use, except once daily over the counter multi-vitamin supplement.
Arms & Interventions
Experimental:Cohort 1-6 Experimental
Intervention AKB 4924 Six subjects per cohort will receive single doses of 20 to up to 480 mg of AKB 4924 orally in a dose escalation format
Intervention: AKB-4924
Placebo:Cohort 1-6
Intervention Placebo: Two subjects per cohort will receive single oral doses of placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Single ascending dose (SAD): Safety and tolerability of AKB-4924
Time Frame: 8 days after a single oral dose
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs and ECG monitoring