HealthyPhase 1NCT06713317
A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers
A Phase 1 study testing HLB3-002 and 0.9% NaCl in people with Healthy, run by Huonslab Co., Ltd. at 1 site in South Korea.
Trial summary
Part I) multi-center, randomized, double-blind, placebo controlled Part II) multi-center, randomized, double-blind, placebo controlled Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HLB3-002 and 0.9% NaCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Dec 2024to 27 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- [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).
Who cannot join
- [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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Part I) multi-center, randomized, double-blind, placebo controlled
Part II) multi-center, randomized, double-blind, placebo controlled
- Conditions
- Healthy
- Being tested
- HLB3-002, 0.9% NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLB3-002Drug
Recombinant Hyaluronidase
0.9% NaClDrug
0.9% Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Part I 'HLB3-002' | Experimental | Recombinant Hyaluronidase Receives: Drug: HLB3-002 |
| Part I '0.9%NaCl' | Experimental | 0.9% Normal Saline Receives: Drug: 0.9% NaCl |
| Part II 'HLB3-002' | Experimental | Recombinant Hyaluronidase Receives: Drug: HLB3-002 |
| Part II '0.9%NaCl' | Experimental | 0.9% Normal Saline Receives: Drug: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of drug allergy following intradermal injection of the IP
Subject developing allergic reaction are considered to have drug allergy.
Measured: 2 days
Secondary outcomes (1)
Incidence rate of drug allergy following subcutaneous injection of the IP
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start2 Dec 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huonslab Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donghoon Lee, MD, Ph.D, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713317
- Sponsor's protocol ID
- HLB3-002_P1
- Status last verified
- Jun 2025
- First submitted
- 26 Nov 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Drug Allergy of HLB3-002 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06713317
- Acronym / sponsor ID
- HLB3-002_P1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Huonslab Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part I) multi-center, randomized, double-blind, placebo controlled
Part II) multi-center, randomized, double-blind, placebo controlled
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part I 'HLB3-002' | Experimental | Drug: HLB3-002Recombinant Hyaluronidase |
| Part I '0.9%NaCl' | Experimental | Drug: 0.9% NaCl0.9% Normal Saline |
| Part II 'HLB3-002' | Experimental | Drug: HLB3-002Recombinant Hyaluronidase |
| Part II '0.9%NaCl' | Experimental | Drug: 0.9% NaCl0.9% Normal Saline |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- [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.
Key exclusion criteria (21 listed)
- [Part I]
- Subjects with the following comorbidities or conditions:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLB3-002Recombinant Hyaluronidase | Drug | Part I 'HLB3-002', Part II 'HLB3-002' |
| 0.9% NaCl0.9% Normal saline | Drug | Part I '0.9%NaCl', Part II '0.9%NaCl' |
Primary outcome
Incidence rate of drug allergy following intradermal injection of the IP
Time frame: 2 days
Subject developing allergic reaction are considered to have drug allergy.
1 secondary outcome
Incidence rate of drug allergy following subcutaneous injection of the IP
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donghoon Lee, MD, Ph.D study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLB3-002 and 0.9% NaCl in people with Healthy, run by Huonslab Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of drug allergy following intradermal injection of the IP (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.