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

Phase 1

• Conditions: Huntington Disease
• Interventions: Drug: Placebo; Drug: CKD-504

• Registration Number: NCT03713892
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-23
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-24
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	investigational Drug
CKD-504	CKD-504	investigational Drug

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of