A Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics and
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0002390
- Lead Sponsor
- Genexine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1.Subject is willing and able to give informed consent after getting explanation on the clinical trials
2.Must be 19-45 years of age, inclusive
3.Weight 50-100kg, BMI of 18.0 kg/m2 or more, but less than 30.0 kg/m2
4.Subject who is adequately able to attend the study based on medical history and physical exam, no clinically significant abnormality from vital sign and clinical laboratory values
5.No clinical abnormality from ECG test
6.Non-smoker (no smoking or no use of any product containing nicotine at least for one month and negative from urine test)
1.Suspected or confirmed malignancy, malignancy history
2.Any clinically significant acute or chronic medical condition requiring care of a physician, in liver, biliary tract, renal, nervous system (CNS or peripheral). respiratory system, endocrine (diabetes, hyperlipemia etc), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction etc), hematology, malignancy, urinary disease, immune system (rheumatologic illness, lupus etc), otorhinolaryngologic diseases
3.Positive to HBsAg, HCV Ab and HIV Ab
4.Are considering or scheduled to undergo any surgical or dental procedure during the study
5.Administered other IP by attending bioequivalence study or other clinical study within recent 3 months
6.Any SAR against vaccines or antibiotics, any medical history with serious allergic diseases
7.Positive from urine drug screen or respiratory alcohol screen at medical screening or check-in
8.History of alcohol, drug, or substance abuse in the past 12 months
9.Consumption of alcohol within 48 hours prior to dosing
10.Medications with antacid, analgesic, herbal administration, vitamin, mineral (except maximum 4 grams of acetaminophen) hormone, steroids, insulin, hypoglycemic drug or other hormone substitute within 14 days before administration
11.Planning pregnancy or donation of sperm/disagreeing proper contraception during the study and 3 months following dosing
12.Do not have veins suitable for cannulation or multiple venepunctures
13.Any other factor that the Investigator thinks will increase subject risk with participation
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of adverse events including abnormaltiy after single subcutaneous(SC) or intramuscular(IM) injection of GX-I7
- Secondary Outcome Measures
Name Time Method Pharmacokinetics parameter (Cmax, Tmax, t1/2, AUCt, AUC(0-inf));Pharmacodynamics parameter (ALC, AUEClast of ALC)