Clinical trial NCT06713317: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Huonslab Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-03
Enrollment: 243
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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


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.

Primary outcomes:
measure: Incidence rate of drug allergy following intradermal injection of the IP
timeFrame: 2 days
Secondary outcomes:
measure: Incidence rate of drug allergy following subcutaneous injection of the IP
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Donghoon Lee, MD, Ph.D
role: STUDY_CHAIR
References: