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

NCT06713317 | Completed Phase 1

• 1 other identifier: HLB3-002_P1
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence rate of drug allergy following intradermal injection of the IP

  Subject developing allergic reaction are considered to have drug allergy.

  2 days

Secondary Outcomes (1)

• Incidence rate of drug allergy following subcutaneous injection of the IP

  4 weeks

Study Arms (4)

Part I 'HLB3-002'

EXPERIMENTAL

Recombinant Hyaluronidase

Drug: HLB3-002

Part I '0.9%NaCl'

EXPERIMENTAL

0.9% Normal Saline

Drug: 0.9% NaCl

Part II 'HLB3-002'

EXPERIMENTAL

Recombinant Hyaluronidase

Drug: HLB3-002

Part II '0.9%NaCl'

EXPERIMENTAL

0.9% Normal Saline

Drug: 0.9% NaCl

Interventions

HLB3-002 DRUG

Recombinant Hyaluronidase

Part I 'HLB3-002'; Part II 'HLB3-002'

0.9% NaCl DRUG

0.9% Normal saline

Part I '0.9%NaCl'; Part II '0.9%NaCl'

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Part I\]
• Healthy volunteers aged 19 years or older at the time of screening (Visit 1).
• 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.
• \[Part II\]
• Subjects who tested negative on the drug allergy assessment after Part 1 intradermal administration.
• For women of childbearing potential, a negative pregnancy test (serum-hCG) at baseline visit (V5).

You may not qualify if:

• \[Part I\]
• 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.
• Subjects who have smoked more than 10 cigarettes per day within 4 weeks prior to the screening (Visit 1).
• Subjects who have participated in another clinical trial and received investigational drugs or medical devices within 6 months prior to the baseline (Visit 2).
• Other subjects deemed inappropriate for participation in this clinical trial by the investigator.
• \[Part II\]
• \) Subjects with the following comorbidities or conditions:

Sponsors & Collaborators

• Huonslab Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Donghoon Lee, MD, Ph.D

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 3, 2024
• Study Start: December 2, 2024
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)