Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects

Study Overview
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Brief Summary
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This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510.

Official Title
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First-in-Human, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of CKD-510 in Single Ascending Dose and Multiple Ascending Dose in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CKD-510 single dose
* Drug: CKD-510 food effect
* Drug: CKD-510 multiple dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subject Non-smoker subject or light smoker Body mass index (BMI) between 18 and 30 kg/m2 inclusive at screening Laboratory parameters within the normal range of the laboratory. Male volunteers must be either vasectomized or agree to use a condom during the course of the study and until 3 months (90 days) after the participant's last visit Signing a written informed consent prior to selection Exclusion Criteria: Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease Blood donation within 2 months before administration General anesthesia within 3 months before administration Presence or history of drug hypersensitivity, or allergic disease Any drug intake (except paracetamol or contraception) during the 28 days prior to the first administration History or presence of alcohol or drug abuse Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development Use of an investigational drug within 3 months (or 90 days) prior to Day1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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
Interventional Model Description: Drug: CKD-510 Drug: Placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>Single dose administration | Drug: CKD-510 single dose<br>* Investigational drug<br>|
| Experimental: Part B<br>Multiple dose administration (food Effect) | Drug: CKD-510 food effect<br>* Investigational drug<br>|
| Experimental: Part C<br>Multiple dose administration | Drug: CKD-510 multiple dose<br>* Investigational drug<br>|
| Placebo Comparator: Placebo<br>Matching placebo | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Part A, Part C] Number of subjects with adverse events (AEs) | The relationship of each adverse event to the investigational product was assessed by the investigator. | Treatment duration up to 4 days | 
| [Part A, Part C] Safety as assessed by vital signs | Symptoms of vital signs will be assessed. | Treatment duration up to 4 days | 
| [Part A, Part C] Safety as assessed by abbreviated physical examination parameters | Physical exmaination will include evaluation of main body systems/regions | Treatment duration up to 4 days | 
| [Part A, Part C] Safety as assessed by electrocardiogram (ECG) parameters | 12-lead ECGs will be obtained during the study using an ECG machine | Treatment duration up to 4 days | 
| [Part A, Part C] Safety as assessed by biological analysis | Biological test will be obtained with assessments including hematology, biochemistry, urinalysis. | Treatment duration up to 4 days | 
| [Part B] Composite of pharmacokinetics (PK) assessments of CKD-510 | PK parameters include plasma concentrations of CKD-510, maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve (AUC) to last measurable concentration [AUC(0-t)], AUC through 24 hours [AUC(0-24)] and AUC per dosing interval [AUC(0-tau)], apparent terminal phase half-life following the last dose (t1/2) in fast or fed conditions. | 3 days post dose | 
| [Part B] Composite of pharmacodynamics (PD) assessments of CKD-510 | Change from baseline in acetylation of alpha-tubulin and histone as pharmacodynamics assessments after an administration of CKD-510 in fast or fed conditions | 3 days post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Part A, Part C] Maximum plasma concentration of CKD-510 | Peak plasma concentration (Cmax) | 4 days post dose (SAD) or 17 days post dose (MAD) | 
| [Part A, Part C] Time of maximum plasma concentration of CKD-510 | Time to reach Cmax (Tmax) | 4 days post dose (SAD) or 17 days post dose (MAD) | 
| [Part A, Part C] Changes from baseline in plasma concentrations CKD-510 in time after dosing | Area under the concentration-time curve from time 0 extrapolated to the last quantifiable concentration at time t (AUC0-t) | 4 days post dose (SAD) or 17 days post dose (MAD) | 
| [Part A, Part C] Time of plasma elimination half-life of CKD-510 | Apparent terminal elimination half-life (t½) | 4 days post dose (SAD) or 17 days post dose (MAD) | 
| [Part A, Part C] Volume of distribution of CKD-510 | Apparent volume of distribution during the terminal elimination phase (Vd/F) | 4 days post dose (SAD) or 17 days post dose (MAD) | 
| [Part A, Part C] Total plasma clearance of CKD-510 | Apparent total plasma clearance (CL/F) | 4 days post dose (SAD) or 17 days post dose (MAD) | 
| [Part A, Part C] Pharmacodynamics assessments of CKD-510 | Change from baseline in acetylation of alpha-tubulin and histone | up to 2 days post dose (SAD) or 17 days post dose (MAD) | 
| [Part B] Number of subjects with adverse events (AEs) | The relationship of each adverse event to the investigational product was assessed by the investigator | 3 days post dose | 
| [Part B] Safety as assessed by vital signs | Symptoms of vital signs will be assessed. | 3 days post dose | 
| [Part B] Safety as assessed by abbreviated physical examination parameters | Physical exmaination will include evaluation of main body systems/regions | 3 days post dose | 
| [Part B] Safety as assessed by electrocardiogram (ECG) parameters | 12-lead ECGs will be obtained during the study using an ECG machine | 3 days post dose | 
| [Part B] Safety as assessed by biological analysis | Biological test will be obtained with assessments including hematology, biochemistry, urinalysis. | 3 days post dose |