Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGCKD-510 single dose
Investigational drug
DRUGCKD-510 food effect
Investigational drug
DRUGCKD-510 multiple dose
Investigational drug
DRUGPlacebo
Matching placebo
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Drug: CKD-510 Drug: Placebo
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [Part A, Part C] Number of subjects with adverse events (AEs) | Treatment duration up to 4 days | The relationship of each adverse event to the investigational product was assessed by the investigator. |
| [Part A, Part C] Safety as assessed by vital signs | Treatment duration up to 4 days | Symptoms of vital signs will be assessed. |
| [Part A, Part C] Safety as assessed by abbreviated physical examination parameters | Treatment duration up to 4 days | Physical exmaination will include evaluation of main body systems/regions |
| [Part A, Part C] Safety as assessed by electrocardiogram (ECG) parameters | Treatment duration up to 4 days | 12-lead ECGs will be obtained during the study using an ECG machine |
| [Part A, Part C] Safety as assessed by biological analysis | Treatment duration up to 4 days | Biological test will be obtained with assessments including hematology, biochemistry, urinalysis. |
| [Part B] Composite of pharmacokinetics (PK) assessments of CKD-510 | 3 days post dose | 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. |
| [Part B] Composite of pharmacodynamics (PD) assessments of CKD-510 | 3 days post dose | Change from baseline in acetylation of alpha-tubulin and histone as pharmacodynamics assessments after an administration of CKD-510 in fast or fed conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| [Part B] Number of subjects with adverse events (AEs) | 3 days post dose | The relationship of each adverse event to the investigational product was assessed by the investigator |
| [Part B] Safety as assessed by vital signs | 3 days post dose | Symptoms of vital signs will be assessed. |
| [Part A, Part C] Maximum plasma concentration of CKD-510 | 4 days post dose (SAD) or 17 days post dose (MAD) | Peak plasma concentration (Cmax) |
| [Part B] Safety as assessed by electrocardiogram (ECG) parameters | 3 days post dose | 12-lead ECGs will be obtained during the study using an ECG machine |
| [Part B] Safety as assessed by biological analysis | 3 days post dose | Biological test will be obtained with assessments including hematology, biochemistry, urinalysis. |
| [Part B] Safety as assessed by abbreviated physical examination parameters | 3 days post dose | Physical exmaination will include evaluation of main body systems/regions |
| [Part A, Part C] Time of maximum plasma concentration of CKD-510 | 4 days post dose (SAD) or 17 days post dose (MAD) | Time to reach Cmax (Tmax) |
| [Part A, Part C] Changes from baseline in plasma concentrations CKD-510 in time after dosing | 4 days post dose (SAD) or 17 days post dose (MAD) | Area under the concentration-time curve from time 0 extrapolated to the last quantifiable concentration at time t (AUC0-t) |
| [Part A, Part C] Time of plasma elimination half-life of CKD-510 | 4 days post dose (SAD) or 17 days post dose (MAD) | Apparent terminal elimination half-life (t½) |
| [Part A, Part C] Volume of distribution of CKD-510 | 4 days post dose (SAD) or 17 days post dose (MAD) | Apparent volume of distribution during the terminal elimination phase (Vd/F) |
| [Part A, Part C] Total plasma clearance of CKD-510 | 4 days post dose (SAD) or 17 days post dose (MAD) | Apparent total plasma clearance (CL/F) |
| [Part A, Part C] Pharmacodynamics assessments of CKD-510 | up to 2 days post dose (SAD) or 17 days post dose (MAD) | Change from baseline in acetylation of alpha-tubulin and histone |
Countries
France
Outcome results
None listed