| Eligibility |
Inclusion Criteria:
1. Adult male or female aged 19 to 55 years at the screening visit (Visit 1)
2. Subject with a Body Mass Index (BMI) of 18kg/m2 or more and 30kg/m2 or less at the
screening visit (Visit 1)
3. Women of childbearing potential who have not undergone sterilization must agree to use
an appropriate method of contraception* during this clinical trial period and up to 3
months after the end of administration of the investigational drug and there must be
evidence of non-fertility at the screening visit (Visit 1)
4. Men who has not undergone a vasectomy must consent to the use of barrier contraception
(i.e., condoms) and if both subejct and partner agree to use an appropriate method of
contraception for the duration of the clinical trial and up to 6 months after the end
of investigational drug administration
5. Subject who can collect blood and urine during this clinical trial period including
the last visit
6. Subject who havs heard the detailed explanation of this clinical trial, have
voluntarily decided to participate, and have agreed in writing to abide by the
precautions
7. Subject who agrees not to donate blood or transfusion (including whole blood, plasma
components, platelet components and platelet plasma components) during the clinical
trial period
Exclusion Criteria:
[Current disease and medical history]
1. Subject who has identified any acute, chronic, or clinically significant disease as a
result of a physical or laboratory examination during a screening visit (Visit 1)
2. Subject who has a history of malignant tumors within the past 5 years
3. Subject who has an immune dysfunction, including immunodeficiency disease, or a family
history thereof through a medical history and/or physical examination
4. Subject who has positive SARS-CoV-2 IgG Ab results during screening visit (Visit 1)
5. Subject previously diagnosed with COVID-19
6. Subject with any acute, chronic, or clinically significant disease as a result of
physical examination or laboratory examination at the screening visit (Visit 1)
7. Subject with a history of malignancy within 5 years before the first dose of the
investigational drug (except for basal cell and squamous cell carcinoma of the skin)
8. Subject with immune dysfunction including immunodeficiency disease through medical
history and/or physical examination, or with a family history
9. Subject with a positive result of virus test (hepatitis B test, hepatitis A test,
human immunodeficiency virus test, hepatitis C test) at the screening visit (Visit 1)
10. Subject who are significantly abnormal clinically in laboratory tests,
electrocardiogram, chest, and X-rays performed at the screening visit (Visit 1) and
those who are judged impossible to participate in the clinical trial at the discretion
of the investigator
11. Subject with a history of hypersensitivity or severe allergic reaction to vaccine
administration [e.g. anaphylaxis, Guillain-Barre syndrome, urticaria*, other
clinically significant reactions requiring medical intervention]
12. Urticaria: Those with a history of systemic urticaria within 5 years before
administration of investigational drugs
13. Subject with diseases on such systems as hepatobiliary, kidney, nervous system
(central or peripheral), respiratory (asthma, pneumonia, etc.), endocrine
(uncontrolled diabetes mellitus, hyperlipidemia, etc.), cardiovascular (congestive
heart failure, coronary artery disease, myocardial infarction, uncontrolled
hypertension) etc.), urinary, psychiatric, musculoskeletal disorders or have a
clinically significant history that it is judged to be unable to participate in a
clinical trial under the judgment of the investigator
14. Subject with autoimmune diseases including autoimmune hypothyroidism and psoriasis
15. Subject with suspected or history of alcohol or substance abuse 12 months prior to the
scheduled screening visit (Visit 1). Alcohol abuse standards are defined as follows:
16. Subject who has had a serious adverse reaction to a drug containing the same component
as the investigational drug or has a history of allergy
17. Subject who has had a cough, dyspnea, chills, muscle pain, headache, sore throat, loss
of smell or taste and an acute fever in which the body temperature exceeds 37.5°C
within 72 hours prior to administration of the clinical trial drug
18. Subject who has been diagnosed with COVID-19 and/or have been confirmed or treated for
COVID-19 infection as a result of laboratory tests
19. Subject with a history of previous MERS-CoV or SARS-CoV infection
20. Subject with a history of hereditary or idiopathic angioneurotic edema
21. Subject with a history of organ or bone marrow transplantation
[Relating to contraindicated drugs]
22. Subject who has experience in administering an immunosuppressant or immune modifying
drug within 6 months prior to administration of an investigational drug
23. Patients with hemophilia who are at risk of serious bleeding when injected
intramuscularly or are taking anticoagulants.
24. Subject who has received immunoglobulin or blood-derived products within 3 months
prior to administration of the investigational drug or are expected to administer it
during the clinical trial period
25. Subject who participated in other clinical trials similar to the investigational drug
before the screening visit (Visit 1)
26. Subject with a history of MERS-CoV or SARS-CoV vaccination
27. Subject who haa received or plan to administer the vaccine within 4 weeks before/after
administration of this investigational drug
28. Subject with a history of platelet-related disease or hemorrhagic disease, a history
of severe bleeding or bruising after intramuscular injection or venipuncture or a
person taking anticoagulants
29. If there is a history of dependent administration of psychotropic drugs or narcotic
analgesics within 6 months prior to administration of the investigational drug or in
case of a mental illness or social condition in which it is difficult to comply with
the clinical trial procedure according to the judgment of the investigator
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