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

NCT ID: NCT06713317

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-06-27

Brief Summary

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

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part I 'HLB3-002'

Recombinant Hyaluronidase

Group Type: EXPERIMENTAL

HLB3-002

Intervention Type: DRUG

Recombinant Hyaluronidase

Part I '0.9%NaCl'

0.9% Normal Saline

Group Type: EXPERIMENTAL

0.9% NaCl

Intervention Type: DRUG

0.9% Normal saline

Part II 'HLB3-002'

Recombinant Hyaluronidase

Group Type: EXPERIMENTAL

HLB3-002

Intervention Type: DRUG

Recombinant Hyaluronidase

Part II '0.9%NaCl'

0.9% Normal Saline

Group Type: EXPERIMENTAL

0.9% NaCl

Intervention Type: DRUG

0.9% Normal saline

Interventions

HLB3-002

Recombinant Hyaluronidase

Intervention Type: DRUG

0.9% NaCl

0.9% Normal saline

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huonslab Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donghoon Lee, MD, Ph.D

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HLB3-002_P1

Identifier Type: -

Identifier Source: org_study_id