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

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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: CKD-510 single dose; Drug: CKD-510 food effect; Drug: CKD-510 multiple dose

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2020
• Primary Completion (Actual): August 24, 2021
• Study Completion (Actual): August 24, 2021

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: A96_01CMT1914

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No