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

Chong Kun Dang Pharmaceutical87 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

CKD-510 single doseDRUG

Investigational drug

CKD-510 food effectDRUG

Investigational drug

CKD-510 multiple doseDRUG

Investigational drug

Placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical site

Grenoble, France

Outcomes

Primary Outcomes

[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.

Time frame: Treatment duration up to 4 days

[Part A, Part C] Safety as assessed by vital signs

Symptoms of vital signs will be assessed.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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