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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: CKD-510 single dose; Drug: CKD-510 multiple dose; Drug: Placebo; Drug: CKD-510 food effect

Study type: Interventional

Funder types: Industry

Identifiers

NCT04746287

A96_01CMT1914

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 4 patient groups, including a placebo group

Part A

Experimental group

Description:

Single dose administration

Treatment:

Drug: CKD-510 single dose

Part B

Experimental group

Description:

Multiple dose administration (food Effect)

Treatment:

Drug: CKD-510 food effect

Part C

Experimental group

Description:

Multiple dose administration

Treatment:

Drug: CKD-510 multiple dose

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo