Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects
Study Details
Study Description
Brief Summary
This study is a first-in-human, randomized, placebo-controlled, 3-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD of orally administered CKD-508 capsules and tablets in healthy subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CKD-508 Capsule in Single Dose Single dose of CKD-508 capsules |
Drug: CKD-508 Capsule
Investigational drug
|
| Placebo Comparator: Placebo Capsule in Single Dose Single dose of Placebo capsules |
Drug: Placebo Capsule
Placebo
|
| Experimental: CKD-508 Tablet in Single Dose Single dose of CKD-508 tablets |
Drug: CKD-508 Tablet
Investigational drug
|
| Placebo Comparator: Placebo Tablet in Single Dose Single dose of Placebo tablets |
Drug: Placebo Tablet
Placebo
|
| Experimental: CKD-508 Tablet in Multiple Dose Multiple dose of CKD-508 tablets |
Drug: CKD-508 Tablet
Investigational drug
|
| Placebo Comparator: Placebo Tablet in Multiple Dose Multiple dose of placebo tablets |
Drug: Placebo Tablet
Placebo
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events [42 days post dose]
The relationship of each adverse event to the investigational product was assessed by the investigator.
- Maximum plasma CKD-508 concentrations after dosing [42 days post dose]
Peak plasma concentration (Cmax)
- Time of maximum plasma CKD-508 concentrations after dosing [42 days post dose]
Time of peak plasma concentration (Tmax)
- Changes from baseline in plasma CKD-508 concentrations in time after dosing [42 days post dose]
Area under the plasma concentration versus time curve (AUC)
Secondary Outcome Measures
- Changes from baseline in LDL-c [21 days post dose]
Pharmacodynamics endpoint
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwick Park Hospital | Harrow | Middlesex | United Kingdom | HA1 3UJ |
Sponsors and Collaborators
- Chong Kun Dang Pharmaceutical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A104-01DL2001