Healthy
Conditions
Brief summary
Part I) multi-center, randomized, double-blind, placebo controlled Part II) multi-center, randomized, double-blind, placebo controlled
Interventions
DRUGHLB3-002
Recombinant Hyaluronidase
DRUG0.9% NaCl
0.9% Normal saline
Sponsors
Huonslab Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\[Part I\] 1. Healthy volunteers aged 19 years or older at the time of screening (Visit 1). 2. 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. \[Part II\] 1. Subjects who tested negative on the drug allergy assessment after Part 1 intradermal administration. 2. For women of childbearing potential, a negative pregnancy test (serum-hCG) at baseline visit (V5).
Exclusion criteria
\[Part I\] 1. 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. 2. Subjects who have smoked more than 10 cigarettes per day within 4 weeks prior to the screening (Visit 1). 3. Subjects who have participated in another clinical trial and received investigational drugs or medical devices within 6 months prior to the baseline (Visit 2). 4. 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of drug allergy following intradermal injection of the IP | 2 days | Subject developing allergic reaction are considered to have drug allergy. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of drug allergy following subcutaneous injection of the IP | 4 weeks |
Countries
South Korea
Outcome results
None listed