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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04488900

Enrollment

Registered

2020-07-28

Start date

2020-07-06

Completion date

2023-07-02

Last updated

2024-02-15

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

Conditions

Healthy Subjects

Brief summary

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.

Interventions

DRUGCKD-508 Capsule

Investigational drug

DRUGPlacebo Capsule

Placebo

DRUGCKD-508 Tablet

Investigational drug

DRUGPlacebo Tablet

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

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