> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-i-study-to-evaluate-the-safety-and-drug-allergy-of-8cd10ee9-0bda-48c9-9a1a-80afe73a9e51 > Record changed: 2026-11-04 # A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers NCT06713317 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) Participants 243 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) Lead sponsor Huonslab Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) Start date 2024-12-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Title and summary **Summary** Part I) multi-center, randomized, double-blind, placebo controlled Part II) multi-center, randomized, double-blind, placebo controlled Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Short title** A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Official title** A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Dates **Completion date** 2025-06-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **First posted** 2024-12-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Registry last updated** 2025-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Primary completion date** 2025-06-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Start date** 2024-12-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Size and sites **Actual participants** 243 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Participants** 243 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Lead sponsor** Huonslab Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Identifiers **Registry ID** NCT06713317 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **ClinicalTrials.gov ID** NCT06713317 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Outcomes ### Primary outcomes 1. Incidence rate of drug allergy following intradermal injection of the IP Timeframe: 2 days Subject developing allergic reaction are considered to have drug allergy. ### Secondary outcomes 1. Incidence rate of drug allergy following subcutaneous injection of the IP Timeframe: 4 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 19 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Sites - Seoul National University HospitalSeoul, South Korea Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06713317) ## Related records ### Drugs (1) - [Sodium chloride](https://trialight.com/data/asset/sodium-chloride-a67c33bc-45ef-42e4-8022-d121f0a86585.md) ### Lead sponsors (1) - [Huonslab Co., Ltd.](https://trialight.com/data/company/huonslab-co-ltd-d6bde977-7d77-47e3-8926-a09aeeddf4f3.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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