A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers

Inclusion criteria

[Part I]

• Healthy volunteers aged 19 years or older at the time of screening (Visit 1).
• Subjects with intact skin at the site of administration, without tattoos, acne, dermatitis, pigmentation, or lesions that could interfere with the administration of the investigational drug and allergy testing.

[Part II]

• Subjects who tested negative on the drug allergy assessment after Part 1 intradermal administration.
• For women of childbearing potential, a negative pregnancy test (serum-hCG) at baseline visit (V5).

Exclusion criteria

[Part I]

• Subjects with the following comorbidities or conditions:

• Acute fever exceeding 37.5°C within 1 week prior to the baseline (Visit 2).
• Symptoms of an acute illness within 2 weeks prior to the baseline (Visit 2).
• Immune disorders that may affect the immune system (e.g., flu, cancer, HIV).
• Chronic urticaria, dermographism.
• Clinically significant diseases affecting the liver, kidneys, gastrointestinal system, cardiovascular system, respiratory system, endocrine system, immune system, psychiatric/neuropsychiatric system, hematologic system, or oncology.
• Clinically significant blood pressure abnormalities.

• Hypertension: Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
• Hypotension: Systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤60 mmHg.
• Subjects who have smoked more than 10 cigarettes per day within 4 weeks prior to the screening (Visit 1).
• Subjects who have participated in another clinical trial and received investigational drugs or medical devices within 6 months prior to the baseline (Visit 2).
• Other subjects deemed inappropriate for participation in this clinical trial by the investigator.

[Part II]

• Subjects with the following comorbidities or conditions:

• Acute fever exceeding 37.5°C within 1 week prior to the baseline (Visit 5).
• Symptoms of an acute illness within 2 weeks prior to the baseline (Visit 5).
• Clinically significant diseases affecting the liver, kidneys, gastrointestinal system, cardiovascular system, respiratory system, endocrine system, immune system, psychiatric/neuropsychiatric system, hematologic system, or oncology.
• Clinically significant blood pressure abnormalities.

• Hypertension: Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg.
• Hypotension: Systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤60 mmHg.