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Completed

NCT Number: NCT04746287

Evaluation of the Safety and Tolerability of CKD-510 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical site

Grenoble, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD-510 single dose

Drug

Investigational drug

CKD-510 food effect

Drug

Investigational drug

CKD-510 multiple dose

Drug

Investigational drug

Placebo

Drug

Matching placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2021
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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