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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HLB3-002; Drug: 0.9% NaCl

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part I 'HLB3-002'; Recombinant Hyaluronidase	Drug: HLB3-002; Recombinant Hyaluronidase
Experimental: Part I '0.9%NaCl'; 0.9% Normal Saline	Drug: 0.9% NaCl; 0.9% Normal saline
Experimental: Part II 'HLB3-002'; Recombinant Hyaluronidase	Drug: HLB3-002; Recombinant Hyaluronidase
Experimental: Part II '0.9%NaCl'; 0.9% Normal Saline	Drug: 0.9% NaCl; 0.9% Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence rate of drug allergy following subcutaneous injection of the IP	4 weeks

Collaborators and Investigators

• Sponsor: Huonslab Co., Ltd.
• Investigators: Study Chair: Donghoon Lee, MD, Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Actual): June 27, 2025
• Study Completion (Actual): June 27, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 1, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Drug Hypersensitivity
• Other Study ID Numbers: HLB3-002_P1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No