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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: CKD-510 multiple dose; Drug: CKD-510 single dose; Drug: CKD-510 food effect; Drug: Placebo

• Registration Number: NCT04746287
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-14
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-09
• Primary Completion: 2021-08-24
• Study Completion: 2021-08-24
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 87

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part C	CKD-510 multiple dose	Multiple dose administration
Part A	CKD-510 single dose	Single dose administration
Part B	CKD-510 food effect	Multiple dose administration (food Effect)
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
[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
[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 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 A, Part C] Safety as assessed by vital signs	Treatment duration up to 4 days	Symptoms of vital signs will be assessed.
[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.

Secondary Outcome Measures

Name	Time	Method
[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 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 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 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] 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
[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 B] Safety as assessed by vital signs	3 days post dose	Symptoms of vital signs will be assessed.
[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.

Trial Locations

Locations (1)

Clinical site; 🇫🇷 Grenoble, France