A Combined Single and Multiple Ascending Dose (SAD-MAD) Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ZKN-0013 in Healthy Subjects

Eloxx Pharmaceuticals (AUS) Pty Ltd0 个研究点目标入组 112 人开始时间: 2024年5月16日最近更新: 2024年9月2日

适应症

试验速览

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•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

发起方

Eloxx Pharmaceuticals (AUS) Pty Ltd