Status:
COMPLETED
Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04488900
Start Date
July 6 2020
End Date
July 2 2023
Last Update
February 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwick Park Hospital
Harrow, Middlesex, United Kingdom, HA1 3UJ