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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2021-08-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects

NCT04488900

Healthy Subjects

COMPLETED PHASE1

A Study to Investigate the Safety, Tolerability, PK, and PD of CKD-508 in Healthy Participants

NCT06727396

Healthy Subjects

RECRUITING PHASE1

Study to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CKD-519

NCT02156544

Dyslipidemia

COMPLETED PHASE1

Phase 1 Study of KH607 Tablets

NCT06393803

Healthy

RECRUITING PHASE1

Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC73077 in Healthy Subjects

NCT05492630

Diabetic Nephropathy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Drug: CKD-510 Drug: Placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A

Single dose administration

Group Type EXPERIMENTAL

CKD-510 single dose

Intervention Type DRUG

Investigational drug

Part B

Multiple dose administration (food Effect)

Group Type EXPERIMENTAL

CKD-510 food effect

Intervention Type DRUG

Investigational drug

Part C

Multiple dose administration

Group Type EXPERIMENTAL

CKD-510 multiple dose

Intervention Type DRUG

Investigational drug

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CKD-510 single dose

Investigational drug

Intervention Type DRUG

CKD-510 food effect

Investigational drug

Intervention Type DRUG

CKD-510 multiple dose

Investigational drug

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes