Clinical trial NCT04488900: Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety and tolerability including treatment-emergent AE and treatment-emergent SAE
timeFrame: 28 days post the final dose
Secondary outcomes:
measure: Maximum plasma CKD-508 concentrations after dosing
timeFrame: 28 days post the final dose
measure: Time of maximum plasma CKD-508 concentrations after dosing
timeFrame: 28 days post the final dose
measure: Changes from baseline in plasma CKD-508 concentrations in time after dosing
timeFrame: 28 days post the final dose
measure: Changes from baseline in CETP activity after dosing
timeFrame: 28 days post the final dose
measure: Changes from baseline in lipid parameters after dosing
timeFrame: 14 days post the final dose
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: Middlesex
Study officials:
References: