Status:
COMPLETED
Safety and Tolerability of GX-P1 in Healthy Male Volunteers
Lead Sponsor:
Genexine, Inc.
Conditions:
Autoimmune Diseases
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1
Eligibility Criteria
Inclusion
- Capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF)
- Healthy male volunteers aged 19-45 years within screening periods
- Body weight of 50-90 kg, and body mass index (BMI) of 18.0-30.0 kg/m2
- Healthy subjects as determined by medical history, physical examination vital signs, ECG and clinical laboratory testing
Exclusion
- Any clinical significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system disease or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation
- History of or current disease evidence including malignant tumor
- History of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug
- Have participated in another clinical trial with investigational drug within 180 days prior to screening period
- Positive for HCV antibody, HBsAg, or HIV antibody at screening period
- Other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04298749
Start Date
August 11 2020
End Date
June 7 2021
Last Update
July 27 2021
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea