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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: HLB3-002; Drug: 0.9% NaCl

• Registration Number: NCT06713317
• Lead Sponsor: Huonslab Co., Ltd.

Brief Summary

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

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-12-01
• Study Start: 2024-12-02
• Study First Posted: 2024-12-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 243

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part I 'HLB3-002'	HLB3-002	Recombinant Hyaluronidase
Part I '0.9%NaCl'	0.9% NaCl	0.9% Normal Saline
Part II 'HLB3-002'	HLB3-002	Recombinant Hyaluronidase
Part II '0.9%NaCl'	0.9% NaCl	0.9% Normal Saline

Primary Outcome Measures

Name	Time	Method
Incidence rate of drug allergy following intradermal injection of the IP	2 days	Subject developing allergic reaction are considered to have drug allergy.

Secondary Outcome Measures

Name	Time	Method
Incidence rate of drug allergy following subcutaneous injection of the IP	4 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of