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Part I) multi-center, randomized, double-blind, placebo controlled
Part II) multi-center, randomized, double-blind, placebo controlled
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I 'HLB3-002' | Experimental | Recombinant Hyaluronidase |
|
| Part I '0.9%NaCl' | Experimental | 0.9% Normal Saline |
|
| Part II 'HLB3-002' | Experimental | Recombinant Hyaluronidase |
|
| Part II '0.9%NaCl' | Experimental | 0.9% Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLB3-002 | Drug | Recombinant Hyaluronidase |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of drug allergy following intradermal injection of the IP | Subject developing allergic reaction are considered to have drug allergy. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of drug allergy following subcutaneous injection of the IP | 4 weeks |
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Inclusion Criteria:
[Part I]
[Part II]
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.
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]
1) 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.
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| Name | Affiliation | Role |
|---|---|---|
| Donghoon Lee, MD, Ph.D | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 0.9% NaCl |
| Drug |
0.9% Normal saline |
|