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

• ClinicalTrials.gov Identifier: NCT04746287
• Recruitment Status: Active, not recruiting
• First Posted: February 9, 2021
• Last Update Posted: February 17, 2021
• Sponsor: Chong Kun Dang Pharmaceutical
• Information provided by (Responsible Party): Chong Kun Dang Pharmaceutical

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: CKD-510 single dose; Drug: CKD-510 food effect; Drug: CKD-510 multiple dose; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Drug: CKD-510 Drug: Placebo
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 14, 2020
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: September 30, 2021

Arms and Interventions

Arm	Intervention/treatment
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
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Matching placebo

Outcome Measures

Primary Outcome Measures :

1. [Part A, Part C] Number of subjects with adverse events (AEs) [ Time Frame: Treatment duration up to 4 days ]
   The relationship of each adverse event to the investigational product was assessed by the investigator.
2. [Part A, Part C] Safety as assessed by vital signs [ Time Frame: Treatment duration up to 4 days ]
   Symptoms of vital signs will be assessed.
3. [Part A, Part C] Safety as assessed by abbreviated physical examination parameters [ Time Frame: Treatment duration up to 4 days ]
   Physical exmaination will include evaluation of main body systems/regions
4. [Part A, Part C] Safety as assessed by electrocardiogram (ECG) parameters [ Time Frame: Treatment duration up to 4 days ]
   12-lead ECGs will be obtained during the study using an ECG machine
5. [Part A, Part C] Safety as assessed by biological analysis [ Time Frame: Treatment duration up to 4 days ]
   Biological test will be obtained with assessments including hematology, biochemistry, urinalysis.
6. [Part B] Composite of pharmacokinetics (PK) assessments of CKD-510 [ Time Frame: 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.
7. [Part B] Composite of pharmacodynamics (PD) assessments of CKD-510 [ Time Frame: 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 Outcome Measures :

1. [Part A, Part C] Maximum plasma concentration of CKD-510 [ Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD) ]
   Peak plasma concentration (Cmax)
2. [Part A, Part C] Time of maximum plasma concentration of CKD-510 [ Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD) ]
   Time to reach Cmax (Tmax)
3. [Part A, Part C] Changes from baseline in plasma concentrations CKD-510 in time after dosing [ Time Frame: 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)
4. [Part A, Part C] Time of plasma elimination half-life of CKD-510 [ Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD) ]
   Apparent terminal elimination half-life (t½)
5. [Part A, Part C] Volume of distribution of CKD-510 [ Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD) ]
   Apparent volume of distribution during the terminal elimination phase (Vd/F)
6. [Part A, Part C] Total plasma clearance of CKD-510 [ Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD) ]
   Apparent total plasma clearance (CL/F)
7. [Part A, Part C] Pharmacodynamics assessments of CKD-510 [ Time Frame: up to 2 days post dose (SAD) or 17 days post dose (MAD) ]
   Change from baseline in acetylation of alpha-tubulin and histone
8. [Part B] Number of subjects with adverse events (AEs) [ Time Frame: 3 days post dose ]
   The relationship of each adverse event to the investigational product was assessed by the investigator
9. [Part B] Safety as assessed by vital signs [ Time Frame: 3 days post dose ]
   Symptoms of vital signs will be assessed.
10. [Part B] Safety as assessed by abbreviated physical examination parameters [ Time Frame: 3 days post dose ]
    Physical exmaination will include evaluation of main body systems/regions
11. [Part B] Safety as assessed by electrocardiogram (ECG) parameters [ Time Frame: 3 days post dose ]
    12-lead ECGs will be obtained during the study using an ECG machine
12. [Part B] Safety as assessed by biological analysis [ Time Frame: 3 days post dose ]
    Biological test will be obtained with assessments including hematology, biochemistry, urinalysis.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

France

Clinical site

Grenoble, France

Sponsors and Collaborators

Chong Kun Dang Pharmaceutical

More Information

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT04746287
• Other Study ID Numbers: A96_01CMT1914
• First Posted: February 9, 2021
• Last Update Posted: February 17, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No