Single and multiple ascending dose study of oral ZKN-0013 or placebo given randomly to healthy volunteers to evaluate the safety, tolerability and the amount of drug in the body after drug administration.
- Conditions
- DermatologySkin - Dermatological conditionsHuman Genetics and Inherited Disorders - Other human genetics and inherited disorders
- Registration Number
- ACTRN12624000632594
- Lead Sponsor
- Eloxx Pharmaceuticals (AUS) Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 112
Healthy females and males ages 18-55 inclusive
- Contraception requirement for woman of child bearing potential and males with female partners of child bearing potential
- Not using prescription medication 14 days prior to admission; and 7 days prior to admission for over-the-counter (OTC) medications/vitamins/supplements (Exceptions contraception, Acetaminophen equal to 2g/day, stand dose of vitamins)
- Non-smoking and no use of any tobacco or nicotine products (by declaration) for a period of at least 1 months prior to screening visit
- Be on no medication with potential to impair hepatic and renal function at the time of screening
- Normal hepatic enzymes and bilirubin
- Normal renal function (glomerular filtration rate greater than 60 mL/min/1.73m2)
- Negative human immunodeficiency virus (HIV) or Hepatitis B surface antigen (HBsAg) or Hepatitis C (HCV) Ab by serology
- No history of alcohol or other drugs of abuse
- Body Mass Index (BMI) of 18.0 to 32.0 kg/m2 (inclusive)
- No vaccines given within 14 days of dosing
- Dosed in another clinical trial within at least 10 tissue half-lives prior to dosing
- Evidence or history of clinically relevant hepatic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within 6 months of screening
- Screening supine BP equal to 140 mm Hg (systolic) or equal to 90 mm Hg (diastolic)
- Screening supine (for 5 minutes) 12-lead electrocardiogram (ECG) demonstrating QTc greater than 450 millisecond for men and greater than 470 millisecond for women, or a QRS interval >120 millisecond
- Subjects with any abnormalities in clinical laboratory tests at screening, considered by the study physician as clinically significant
- Pregnant or breastfeeding female subjects
- Subjects who donated blood or received blood or plasma derivatives in 30 days preceding study drug administration
- Subjects with any acute medical situation (e.g., acute infection) within 48 hours (h) of - Screening or start of dosing
- Major surgery within last 3 months, or minor surgery in the last 1 month, or any planned surgery during the trial.
- Any other condition or prior therapy that in the opinion of the study physician or designee would make the participant unsuitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method