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

Huntington Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713892
• Other study ID #: 175MAD17021
• Status: Recruiting
• Phase: Phase 1
• Start date: May 23, 2018
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: Min Ji Song
• Phone: 82-2-3149-7853
• Email: songmj[@]ckdpharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• CKD-504
orally administered once with investigational drug assigned on 1d morning with 240 mL of water
• Placebo
orally administered

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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