CKD-504 in SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects

Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, PK, PD of CKD-504 in Single SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03713892

Enrollment

Registered

2018-10-22

Start date

2018-05-23

Completion date

2020-12-31

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington Disease

Brief summary

To assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of CKD-504 compared to placebo in healthy Korean and Caucasian adult subjects

Interventions

DRUGCKD-504

orally administered once with investigational drug assigned on 1d morning with 240 mL of water

DRUGPlacebo

orally administered

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adult Korean or Caucasian aged 19 to 45 (inclusive) years, at the time of screening. * Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit. * Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study. * Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.

Exclusion criteria

* Subjects with a history of hypersensitivities to the drug, including investigational drugs or other drugs or with a history of clinically significant hypersensitivities. * Subjects with a history of drug abuse or a positive urine screening for drug abuse. * Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within three months prior to study drug administration. * Subjects who have donated a unit of whole blood within 60 days or blood components within 30 days prior to study drug administration. * Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.

Design outcomes

Primary

Measure	Time frame	Description
Cmax of CKD-504	Day1, Day2, Day3, Day4	Peak Plasma Concentration (Cmax) of CKD-504
AUC of CKD-504	Day1, Day2, Day3, Day4	Area under the plasma concentration versus time curve (AUC) of CKD-504

Countries

South Korea

Contacts

Primary ContactMin Ji Song

songmj@ckdpharm.com82-2-3149-7853

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026