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

A Phase 1, First-in-Human, Double-blind, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, PK and PD and Food Effect of CKD-508 After Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects

This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: CKD-508 Capsule; Drug: Placebo Capsule; Drug: CKD-508 Tablet; Drug: Placebo Tablet

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pablo Forte Soto, M.D; Phone Number: +44 (0)1895 614355; Email: Pablo.ForteSoto@parexel.com

Study Locations

• United Kingdom
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • Northwick Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures.
• Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
• Females of non-childbearing potential (surgically sterile [hysterectomy or oophorectomy] or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone (FSH) in postmenopausal range confirmed by an FSH test).
• Males must be unable to procreate (defined as surgically sterile [i.e., had a vasectomy ≥6 months prior to screening]) or must agree to use highly effective form of birth control from screening through 90 days after study completion.
• Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months).

Exclusion Criteria:

• Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the PI or designee.
• Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
• Subject has any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study.
• Subject has history of alcohol and/or illicit drug abuse within 2 years of Screening Visit.
• Subject has positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1. CKD-508 Capsule in Single Dose; Single dose of CKD-508 capsules	Drug: CKD-508 Capsule; Investigational drug
Placebo Comparator: Part 1. Placebo Capsule in Single Dose; Single dose of Placebo capsules	Drug: Placebo Capsule; Placebo
Experimental: Part 2. CKD-508 Tablet in Single Dose; Single dose of CKD-508 tablets for biocompartibility	Drug: CKD-508 Tablet; Investigational drug
Placebo Comparator: Part 2. Placebo Tablet in Single Dose; Single dose of Placebo tablets for biocompartibility	Drug: Placebo Tablet; Placebo
Experimental: Part 3. CKD-508 Tablet in Single Dose; Single dose of CKD-508 tablets for food effect	Drug: CKD-508 Tablet; Investigational drug
Placebo Comparator: Part 3. Placebo Tablet in Single Dose; Single dose of Placebo tablets for food effect	Drug: Placebo Tablet; Placebo
Experimental: Part 4. CKD-508 Tablet in Multiple Dose; Multiple dose of CKD-508 tablets	Drug: CKD-508 Tablet; Investigational drug
Placebo Comparator: Part 4. Placebo Tablet in Multiple Dose; Multiple dose of placebo tablets	Drug: Placebo Tablet; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability including treatment-emergent AE and treatment-emergent SAE	28 days post the final dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma CKD-508 concentrations after dosing	Peak plasma concentration (Cmax)	28 days post the final dose
Time of maximum plasma CKD-508 concentrations after dosing	Time of peak plasma concentration (Tmax)	28 days post the final dose
Changes from baseline in plasma CKD-508 concentrations in time after dosing	Area under the plasma concentration versus time curve (AUC)	28 days post the final dose
Changes from baseline in CETP activity after dosing	Pharmacodynamics endpoint	28 days post the final dose
Changes from baseline in lipid parameters after dosing	including, but not limited to the following: LDL-C, etc. Pharmacodynamics endpoint	14 days post the final dose

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): July 2, 2023
• Study Completion (Actual): July 2, 2023

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: A104-01DL2001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No