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

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: Huntington Disease

Treatments: Drug: Placebo; Drug: CKD-504

Study type: Interventional

Funder types: Industry

Identifiers

NCT03713892

175MAD17021

Details and patient eligibility

About

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

Enrollment: 88 estimated patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

CKD-504

Experimental group

Description:

investigational Drug

Treatment:

Drug: CKD-504

Placebo

Placebo Comparator group

Description:

investigational Drug

Treatment:

Drug: Placebo