A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers
- Summary
- Part I) multi-center, randomized, double-blind, placebo controlled Part II) multi-center, randomized, double-blind, placebo controlled
- Short title
- A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers
- Official title
- A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-06-27
- First posted
- 2024-12-03
- Registry last updated
- 2025-07-01
- Primary completion date
- 2025-06-27
- Start date
- 2024-12-02
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Huonslab Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06713317
- ClinicalTrials.gov ID
- NCT06713317
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Incidence rate of drug allergy following intradermal injection of the IP
Timeframe: 2 days
Subject developing allergic reaction are considered to have drug allergy.
Incidence rate of drug allergy following subcutaneous injection of the IP
Timeframe: 4 weeks
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 19 Years
- Healthy volunteers
- Yes
[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).
[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]
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.
- Seoul National University HospitalSeoul, South Korea