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

Huonslab Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 0.9% NaCl; Drug: HLB3-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT06713317

HLB3-002_P1

Details and patient eligibility

About

Part I) multi-center, randomized, double-blind, placebo controlled

Part II) multi-center, randomized, double-blind, placebo controlled

Enrollment: 243 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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243 participants in 4 patient groups

Part I 'HLB3-002'

Experimental group

Description:

Recombinant Hyaluronidase

Treatment:

Drug: HLB3-002

Part I '0.9%NaCl'

Experimental group

Description:

0.9% Normal Saline

Treatment:

Drug: 0.9% NaCl

Part II 'HLB3-002'

Experimental group

Description:

Recombinant Hyaluronidase

Treatment:

Drug: HLB3-002

Part II '0.9%NaCl'

Experimental group

Description:

0.9% Normal Saline

Treatment:

Drug: 0.9% NaCl