Status:
COMPLETED
Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the s...
Eligibility Criteria
Inclusion
- Healthy male subject
- Non-smoker subject or light smoker
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive at screening
- Laboratory parameters within the normal range of the laboratory.
- Male volunteers must be either vasectomized or agree to use a condom during the course of the study and until 3 months (90 days) after the participant's last visit
- Signing a written informed consent prior to selection
Exclusion
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease
- Blood donation within 2 months before administration
- General anesthesia within 3 months before administration
- Presence or history of drug hypersensitivity, or allergic disease
- Any drug intake (except paracetamol or contraception) during the 28 days prior to the first administration
- History or presence of alcohol or drug abuse
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- Use of an investigational drug within 3 months (or 90 days) prior to Day1
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2021
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04746287
Start Date
January 14 2020
End Date
August 24 2021
Last Update
May 4 2022
Active Locations (1)
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1
Clinical site
Grenoble, France