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

NCT04746287 | Completed Phase 1 DMC

• 1 other identifier: A96_01CMT1914
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• [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 Outcomes (12)

• [Part A, Part C] Maximum plasma concentration of CKD-510

  4 days post dose (SAD) or 17 days post dose (MAD)

• [Part A, Part C] Time of maximum plasma concentration of CKD-510

  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

  4 days post dose (SAD) or 17 days post dose (MAD)

• [Part A, Part C] Time of plasma elimination half-life of CKD-510

  4 days post dose (SAD) or 17 days post dose (MAD)

• [Part A, Part C] Volume of distribution of CKD-510

  4 days post dose (SAD) or 17 days post dose (MAD)

Study Arms (4)

Part A

EXPERIMENTAL

Single dose administration

Drug: CKD-510 single dose

Part B

EXPERIMENTAL

Multiple dose administration (food Effect)

Drug: CKD-510 food effect

Part C

EXPERIMENTAL

Multiple dose administration

Drug: CKD-510 multiple dose

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

CKD-510 single dose DRUG

Investigational drug

Part A

CKD-510 food effect DRUG

Investigational drug

Part B

CKD-510 multiple dose DRUG

Investigational drug

Part C

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Clinical site

Grenoble, France

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Drug: CKD-510 Drug: Placebo

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 9, 2021
• Study Start: January 14, 2020
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

FR (1)