A Phase 1, First-in-Human, Double-blind, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, PK and PD and Food Effect of CKD-508 After Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects

A104-01DL2001

This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.

2020-07-06

2023-07-02

2023-07-02

Completed

Early phase I

88

Inclusion Criteria: * Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures. * Males and females between 18 to 55 years of age, inclusive, at the Screening Visit. * Females of non-childbearing potential (surgically sterile \[hysterectomy or oophorectomy\] or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone (FSH) in postmenopausal range confirmed by an FSH test). * Males must be unable to procreate (defined as surgically sterile \[i.e., had a vasectomy ≥6 months prior to screening\]) or must agree to use highly effective form of birth control from screening through 90 days after study completion. * Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months). Exclusion Criteria: * Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the PI or designee. * Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs. * Subject has any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study. * Subject has history of alcohol and/or illicit drug abuse within 2 years of Screening Visit. * Subject has positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody.

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2024-02-15