| Eligibility |
Inclusion Criteria:
1. Healthy adults aged 19 or older and 55 or younger at the time of screening test
2. A person who weighs 55.0 kg or more and whose BMI (body mass index) is above 18.0 and
below 29.9;
3. A person who has listened to the detailed explanation of this clinical trial and fully
understood, decided to participate voluntarily, and agreed in writing before the
screening procedure.
4. A person who is eligible for this test when determining the person in charge of the
test (or co-researcher who has been commissioned) due to physical examination,
clinical laboratory examination, or examination.
5. A person who has been tested negative for Corona-19 virus (COVID-19) infection
conducted during a screening visit.
6. A person who has agreed to use medically acceptable contraception during the
pre-clinical trial period;
Exclusion Criteria:
1. A person with a history or medical condition that includes one or more of the
following diseases:
1. A person who is hypersensitive or has an history of overreaction to a clinical
trial medication (or a component of a clinical trial medication) or emergency
medication (epinephrine, dexamethasone, etc.)
2. hepatitis B (active hepatitis B or carrier), hepatitis C, human immunodeficiency
virus (HIV), or syphilis infection (unless fully cured in case of hepatitis B
virus history)
3. A person who is deemed clinically significant in determining the test manager (or
a joint researcher) for the past or present history of asthma, rash, vascular
edema, eczema, etc.
4. A person who has clinical significance, liver, kidney, nervous system,
respiratory system, endocrine system, blood, tumor, cardiovascular, urinary
system, mental system disease, or history
5. A person who has a history of malignant tumors in the past or present
6. A person who has a history of whole-body anti-infection that has been terminated
within 28 days prior to the administration of clinical trial medication, or a
history of systemic or local infection that requires hospitalization or
intravenous administration within 6 months before clinical trial medication is
administered.
7. A person who has undergone surgical intervention or surgery within 28 days prior
to the administration of a clinical trial medication or is scheduled to undergo
surgical procedures during the clinical trial period.
8. A person who has a clinically significant blood clotting disorder or tendency to
hemorrhagic
2. A person who shows the following results in a screening test:
? A person whose blood level of AST (SGOT) and ALT (SGPT) exceeds twice the upper
limit of the reference range ? A person whose blood treatment line level exceeds the
upper limit of the reference range or whose eGFR calculated by the Modification of
Diet in Rental Disase (MDR) formula is less than 90ml/min/1.73? ? A person who has
been found to be abnormal in the 12-lead ECG test ? In the vital signs measured at the
left position after a rest for more than three minutes, a person who showed a figure
equivalent to systolic blood pressure of "90 mmHg or > 150 mmHg or extended blood
pressure of "60 mmHg or >100 mmHg." ? A person who has tested positive for serum (RPR
Ab, anti-HIV (AIDS), HBs Ag, HCV Ab) ? A person whose C-reactive protein (CRP) level
is 1.5 times higher than the upper limit of the reference range.
? In addition, a person who showed the results of a decision that the test manager (or
a commissioned joint researcher) is clinically significant;
3. A person who has a history of drug abuse or has tested positive for abuse in urine
drug testing
4. A person who participated in other clinical trials (including biological equivalence
tests) within six months prior to the administration of the clinical trial medication
(one test subject cannot participate in another cohort)
5. A person who has given full blood or blood donation within two months or within one
month before the administration of a clinical trial medication or received blood
transfusion within one month before the administration of a clinical trial medication.
6. A person who drinks continuously (21 units/week, 1 unit = 10 g of pure alcohol) within
three months prior to administration of clinical trial medication, or cannot drink
alcohol during hospitalization.
7. A person who smokes more than 10 cigarettes a day within one month prior to the
administration of a clinical trial medication or who is not allowed to smoke during
the hospitalization period.
8. A person who is not prohibited from eating anything other than food provided by the
clinical testing institution during his/her admission period;
9. A male person who has a child plan or plans to donate sperm during the period prior to
the clinical trial, or a female person who has a plan to conceive or breast-feed.
10. In addition to the above criteria, a person deemed inappropriate for the participation
of a clinical trial by the person in charge of testing (or a joint researcher who has
been delegated)
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