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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Single dose administration |
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| Part B | Experimental | Multiple dose administration (food Effect) |
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| Part C | Experimental | Multiple dose administration |
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| Placebo | Placebo Comparator | Matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-510 single dose | Drug | Investigational drug |
| |
| CKD-510 food effect |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical site | Grenoble | France |
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Drug: CKD-510 Drug: Placebo
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| Drug |
Investigational drug |
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| CKD-510 multiple dose | Drug | Investigational drug |
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| Placebo | Drug | Matching placebo |
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| [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 |
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 |