Evaluating the safety and allergy response to HLB3-002 in healthy volunteers
A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers
This study is testing the safety and allergy responses to a new drug called HLB3-002 in healthy volunteers to see how it affects them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 243 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Huonslab Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06713317 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and potential allergic reactions to the investigational drug HLB3-002 in healthy volunteers. It is designed as a multi-center, randomized, double-blind, placebo-controlled trial, which will be conducted in two parts. In Part I, healthy participants will receive either the drug or a placebo, followed by allergy testing. Part II will involve subjects who tested negative for drug allergies in Part I, ensuring a thorough evaluation of the drug's safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy volunteers aged 19 years or older with intact skin at the administration site.
Not a fit: Patients with acute illnesses, immune disorders, or significant comorbidities may not benefit from participation in this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of HLB3-002, potentially leading to its approval for use in broader populations.
How similar studies have performed: While this study follows a common design for safety evaluations, the specific drug HLB3-002 is novel and has not been tested in this manner before.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Dahye Jung
- Email: dhjung@huons.com
- Phone: +82-70-7492-5768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.