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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04746287
• Other study ID #: A96_01CMT1914
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2020
• Est. completion date: August 24, 2021

Study information

• Verified date: May 2022
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CKD-510 single dose
Investigational drug
• CKD-510 food effect
Investigational drug
• CKD-510 multiple dose
Investigational drug
• Placebo
Matching placebo

Locations

Country	Name	City	State
France	Clinical site	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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
Primary	[Part A, Part C] Safety as assessed by vital signs	Symptoms of vital signs will be assessed.	Treatment duration up to 4 days
Primary	[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
Primary	[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
Primary	[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
Primary	[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
Primary	[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	[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)
Secondary	[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)
Secondary	[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)
Secondary	[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)
Secondary	[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)
Secondary	[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)
Secondary	[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)
Secondary	[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
Secondary	[Part B] Safety as assessed by vital signs	Symptoms of vital signs will be assessed.	3 days post dose
Secondary	[Part B] Safety as assessed by abbreviated physical examination parameters	Physical exmaination will include evaluation of main body systems/regions	3 days post dose
Secondary	[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
Secondary	[Part B] Safety as assessed by biological analysis	Biological test will be obtained with assessments including hematology, biochemistry, urinalysis.	3 days post dose