Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects

Phase 1

Completed

Interventions: Drug: CKD-508 Tablet
Drug: Placebo Tablet
Drug: Placebo Capsule
Drug: CKD-508 Capsule

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Part 2. CKD-508 Tablet in Single Dose	CKD-508 Tablet	Single dose of CKD-508 tablets for biocompartibility
Part 3. Placebo Tablet in Single Dose	Placebo Tablet	Single dose of Placebo tablets for food effect
Part 2. Placebo Tablet in Single Dose	Placebo Tablet	Single dose of Placebo tablets for biocompartibility
Part 1. Placebo Capsule in Single Dose	Placebo Capsule	Single dose of Placebo capsules
Part 3. CKD-508 Tablet in Single Dose	CKD-508 Tablet	Single dose of CKD-508 tablets for food effect
Part 1. CKD-508 Capsule in Single Dose	CKD-508 Capsule	Single dose of CKD-508 capsules
Part 4. CKD-508 Tablet in Multiple Dose	CKD-508 Tablet	Multiple dose of CKD-508 tablets
Part 4. Placebo Tablet in Multiple Dose	Placebo Tablet	Multiple dose of placebo tablets

Primary Outcome Measures

Name	Time	Method
Safety and tolerability including treatment-emergent AE and treatment-emergent SAE	28 days post the final dose

Secondary Outcome Measures

Name	Time	Method
Maximum plasma CKD-508 concentrations after dosing	28 days post the final dose	Peak plasma concentration (Cmax)
Time of maximum plasma CKD-508 concentrations after dosing	28 days post the final dose	Time of peak plasma concentration (Tmax)
Changes from baseline in CETP activity after dosing	28 days post the final dose	Pharmacodynamics endpoint
Changes from baseline in plasma CKD-508 concentrations in time after dosing	28 days post the final dose	Area under the plasma concentration versus time curve (AUC)
Changes from baseline in lipid parameters after dosing	14 days post the final dose	including, but not limited to the following: LDL-C, etc. Pharmacodynamics endpoint

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