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

Study Overview
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Brief Summary
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This study is a first-in-human, randomized, placebo-controlled, 3-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD of orally administered CKD-508 capsules and tablets in healthy subjects.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: CKD-508 Capsule
* Drug: Placebo Capsule
* Drug: CKD-508 Tablet
* Drug: Placebo Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-508 Capsule in Single Dose<br>Single dose of CKD-508 capsules | Drug: CKD-508 Capsule<br>* Investigational drug<br>|
| Placebo Comparator: Placebo Capsule in Single Dose<br>Single dose of Placebo capsules | Drug: Placebo Capsule<br>* Placebo<br>|
| Experimental: CKD-508 Tablet in Single Dose<br>Single dose of CKD-508 tablets | Drug: CKD-508 Tablet<br>* Investigational drug<br>|
| Placebo Comparator: Placebo Tablet in Single Dose<br>Single dose of Placebo tablets | Drug: Placebo Tablet<br>* Placebo<br>|
| Experimental: CKD-508 Tablet in Multiple Dose<br>Multiple dose of CKD-508 tablets | Drug: CKD-508 Tablet<br>* Investigational drug<br>|
| Placebo Comparator: Placebo Tablet in Multiple Dose<br>Multiple dose of placebo tablets | Drug: Placebo Tablet<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | The relationship of each adverse event to the investigational product was assessed by the investigator. | 42 days post dose | 
| Maximum plasma CKD-508 concentrations after dosing | Peak plasma concentration (Cmax) | 42 days post dose | 
| Time of maximum plasma CKD-508 concentrations after dosing | Time of peak plasma concentration (Tmax) | 42 days post dose | 
| Changes from baseline in plasma CKD-508 concentrations in time after dosing | Area under the plasma concentration versus time curve (AUC) | 42 days post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in LDL-c | Pharmacodynamics endpoint | 21 days post dose |