Clinical trial NCT04746287: Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 87
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Drug: CKD-510 Drug: Placebo
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: [Part A, Part C] Number of subjects with adverse events (AEs)
timeFrame: Treatment duration up to 4 days
measure: [Part A, Part C] Safety as assessed by vital signs
timeFrame: Treatment duration up to 4 days
measure: [Part A, Part C] Safety as assessed by abbreviated physical examination parameters
timeFrame: Treatment duration up to 4 days
measure: [Part A, Part C] Safety as assessed by electrocardiogram (ECG) parameters
timeFrame: Treatment duration up to 4 days
measure: [Part A, Part C] Safety as assessed by biological analysis
timeFrame: Treatment duration up to 4 days
measure: [Part B] Composite of pharmacokinetics (PK) assessments of CKD-510
timeFrame: 3 days post dose
measure: [Part B] Composite of pharmacodynamics (PD) assessments of CKD-510
timeFrame: 3 days post dose
Secondary outcomes:
measure: [Part A, Part C] Maximum plasma concentration of CKD-510
timeFrame: 4 days post dose (SAD) or 17 days post dose (MAD)
measure: [Part A, Part C] Time of maximum plasma concentration of CKD-510
timeFrame: 4 days post dose (SAD) or 17 days post dose (MAD)
measure: [Part A, Part C] Changes from baseline in plasma concentrations CKD-510 in time after dosing
timeFrame: 4 days post dose (SAD) or 17 days post dose (MAD)
measure: [Part A, Part C] Time of plasma elimination half-life of CKD-510
timeFrame: 4 days post dose (SAD) or 17 days post dose (MAD)
measure: [Part A, Part C] Volume of distribution of CKD-510
timeFrame: 4 days post dose (SAD) or 17 days post dose (MAD)
measure: [Part A, Part C] Total plasma clearance of CKD-510
timeFrame: 4 days post dose (SAD) or 17 days post dose (MAD)
measure: [Part A, Part C] Pharmacodynamics assessments of CKD-510
timeFrame: up to 2 days post dose (SAD) or 17 days post dose (MAD)
measure: [Part B] Number of subjects with adverse events (AEs)
timeFrame: 3 days post dose
measure: [Part B] Safety as assessed by vital signs
timeFrame: 3 days post dose
measure: [Part B] Safety as assessed by abbreviated physical examination parameters
timeFrame: 3 days post dose
measure: [Part B] Safety as assessed by electrocardiogram (ECG) parameters
timeFrame: 3 days post dose
measure: [Part B] Safety as assessed by biological analysis
timeFrame: 3 days post dose
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinical site
Study officials:
References: