Health, SubjectivePhase 1NCT05232175
Clinical Study of ALT-BB4 to Determine Tolerance, Safety and Pharmacokinetics in Healthy Volunteer
A Phase 1 study testing ALT-BB4 and 0.9%NaCl in people with Health, Subjective, run by Alteogen, Inc. at 1 site in South Korea.
Trial summary
A Phase I Study to Evaluate the Tolerance, Safety and Pharmacokinetics of ALT-BB4 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- ALT-BB4 and 0.9%NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jan 2022to 24 Aug 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Common
- Healthy volunteers aged ≥19 years at the time of Screening (Visit 1)
- Female subjects or male subjects' female partner must be menopausal or should have received a sterilization procedure or have agreed to use contraceptive methods during the study period, as defined below:
- Post-menopausal female subjects or male subjects' female partners (non-drug induced amenorrhea for at least 12 months or confirmed diagnosis with menopause)
- Female subjects or male subjects' female partners who have received a sterilization procedure (removal of ovary and/or uterus)
- Subjects who have agreed to practice total abstinence during the study period [For female subjects, periodic abstinence (e.g., ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.]
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- When female subjects or male subjects' female partners are women of childbearing potential (WOCBP) who have not received a sterilization procedure, they must agree to use of following contraceptive methods:
- Hormones (implantable, patch, and oral)
- Intrauterine device (IUD)
- Double barrier methods (concomitant use of two of following contraceptive methods: male condom, female condom, cervical cap, diaphragm, sponge, spermicide) (However, concomitant use of male condom and female condom is excluded from double barrier methods.)
- WOCBP or females who have the last menstrual period within 12 months must have a negative serum or urine pregnancy test at Screening (Visit 1).
- Subjects who have voluntarily decided to take part in the study and able to comply with the study protocol
- Subjects who have no tattoo, acne, dermatitis, pigmentation or lesion on the administration site and who have no damage in the skin, so that they can receive the IP and allergy test
- Subjects determined eligible for the study through Screening tests (vital signs, physical examination, medical history and surgery history, ECG, and laboratory tests)
- Part II-A
- Subjects with BMI no less than 18.5 kg/m2, no greater than 24.9 kg/m2
Who cannot join
- Common
- Subjects who have received or treated with following medications within the specified timeframe prior to Screening (Visit 1) or who are expected to receive them during the study period:
- Within 1 month: Hyaluronidase, Chemotherapeutic agent, non-steroidal anti-inflammatory drugs (NSAIDs; e.g.: Aspirin, Aceclofenac, etc.), penicillins antibiotics (e.g.: Amoxicillin, Ampicillin, etc.), cephalosporins antibiotics (e.g.: Cefaclor, Cefadroxil, Cefixime, etc.), sulfonamides antibiotics (e.g.: Sulfadiazine, Sulfamethoxazole, etc.), quinolones antibiotics (e.g.: Ciprofloxacin, Levofloxacin, etc.), Glucocorticosteroid, Immunosuppressive agent
- Within 14 days: Antihistamine (e.g.: Chlorpheniramine, Hydroxyzine, Ketotifen, etc.)
- Subjects who have prior history of clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, hematology/neoplasm, cardiovascular system, mental (mood disorder, obsessive-compulsive disorder), gastrointestinal disorders or surgical history
- Subjects with acute fever > 37.5℃ within 7 days from the expected IP administration or showing symptoms suspecting acute diseases within 14 days from the expected IP administration
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- Subjects who do not have normal blood pressure*
- Range of normal blood pressure is defined as systolic and diastolic blood <120/80 mmHg in accordance with 2018 Korean Society of Hypertension Guidelines for the Management of Hypertension24) (however, Pre-hypertension (≥ 130/80) is excluded that may occur in normotension).
- Subjects who persistently drink more than the weekly recommended alcohol units* 14 g of alcohol content per unit is applied, which corresponds to 1 can (small bottle) of beer (5%), 350 mL of draft beer (5%), 1 cup (300 mL) of makgeoli, 1 glass (150 mL) of wine (12%), 1/4 bottle (90 mL) of soju (20%), and 1 shot (45 mL) of liquor (40%). Moderate amount of alcohol by age and gender is provided below:23) Age Recommended unit per week Adults (≥ 19 and < 65 years) Male: 8 units/week Female: 4 units/week Elderly (≥ 65 years) Male: 4 units/week Female: 2 units/week
- Subjects of usual smoker (exceeding 10 cigarettes per day)
- Subjects who have a past history of autoimmune diseases (e.g.: rheumatoid arthritis, etc.) or active immune diseases that may affect the immune system [e.g.: flu, cancer, Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV) etc.], diabetes mellitus, heart diseases, asthma, sinusitis, chronic urticaria, dermographism, or any skin conditions that may affect post-IP administration assessments (e.g.: Dermatitis, dermatomycosis and other skin diseases or tattoo)
- Subjects with known allergic reactions or hypersensitivity to bee sting or other common allergens or known contraindications to hyaluronidase, thimerosal (disinfectants) and EDTA
- Subjects with hypersensitivity to the IP or its ingredients or a history of anaphylaxis
- Past history of drug abuse
- Subjects who have participated in other clinical trials within 6 months prior to the expected IP administration
- Others determined ineligible for the study participation in the opinion of investigator
- Part II-A
- Subjects who have been treated with a drug-metabolizing enzyme inducers and inhibitors*25), 26) within 30 days prior to the IP administration
- Example: Phenytoin, Carbamazepine, Barbiturates, Rifampicin, Griseofulvin, Cimetidine, Disulfiram, Erythromycin, Ketoconazole, Fluconazole, Itraconazole, Valproic acid, Isoniazid, Ciprofloxacin, Omeprazole, Clarithromycin, Quinidine, Sulfonamides, etc.
- Subjects who have significant bleeding or blood loss within 60 days prior to Screening (Visit 1)
- Subjects who have donated whole blood within 60 days or donated blood by apheresis within 14 days or received transfusion within 14 days prior to Screening (Visit 1)
- Subjects who have consumed grapefruit juice28) within 7 days prior to Screening (Visit 1)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Tolerance, Safety and Pharmacokinetics of ALT-BB4 in Healthy Volunteer
A Phase I Study to Evaluate the Tolerance, Safety and Pharmacokinetics of ALT-BB4 in Healthy Volunteers
- Conditions
- Health, Subjective
- Being tested
- ALT-BB4, 0.9%NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALT-BB4Drug
Recombinant Hyaluronidase
0.9%NaClDrug
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Part I (Allergy assessment) - ALT-BB4 | Experimental | Not described Receives: Drug: ALT-BB4 |
| Part I (Allergy assessment) - 0.9%NaCl | Placebo comparator | Not described Receives: Drug: 0.9%NaCl |
| Part II-A (PK assessment) | Experimental | Not described Receives: Drug: ALT-BB4 |
| Part II-B (Safety assessment) - ALT-BB4 | Experimental | Not described Receives: Drug: ALT-BB4 |
| Part II-B (Safety assessment) - 0.9% NaCl | Placebo comparator | Not described 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 ID Injection of the IP
Subject developing either immediate or delayed allergic reaction are considered to have drug allergy.
Measured: 2 days
Injection-site TEAEs (Treatment Emergent Adverse Events)
Incident rate of administration site-related adverse events in Part Ⅱ-B
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 posted9 Feb 2022
- Study start18 Jan 2022
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health, SubjectiveStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alteogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232175
- Sponsor's protocol ID
- ALT-BB4-01
- Status last verified
- Dec 2025
- First submitted
- 14 Jan 2022
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Publications
Lee JS, Kim W, Won CH, Lee YW, Lee S, Won H, Park SJ, Lee S, Kim SH, Yang J, Bahn G, Lee DH. The Safety, Tolerability, and Pharmacokinetics of ALT-BB4 (A Novel Recombinant Hyaluronidase): A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study in Healthy Volunteers. Dermatol Ther (Heidelb). 2025 Nov;15(11):3301-3311. doi: 10.1007/s13555-025-01507-x. Epub 2025 Sep 2.
PubMed 40892310
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Tolerance, Safety and Pharmacokinetics of ALT-BB4 in Healthy Volunteer
- ClinicalTrials.gov ID
- NCT05232175
- Acronym / sponsor ID
- ALT-BB4-01
- Conditions
- Health, Subjective
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Alteogen, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I Study to Evaluate the Tolerance, Safety and Pharmacokinetics of ALT-BB4 in Healthy Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part I (Allergy assessment) - ALT-BB4 | Experimental | Drug: ALT-BB4 |
| Part I (Allergy assessment) - 0.9%NaCl | Placebo comparator | Drug: 0.9%NaCl |
| Part II-A (PK assessment) | Experimental | Drug: ALT-BB4 |
| Part II-B (Safety assessment) - ALT-BB4 | Experimental | Drug: ALT-BB4 |
| Part II-B (Safety assessment) - 0.9% NaCl | Placebo comparator | Drug: 0.9%NaCl |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Common
- Healthy volunteers aged ≥19 years at the time of Screening (Visit 1)
- Female subjects or male subjects' female partner must be menopausal or should have received a sterilization procedure or have agreed to use contraceptive methods during the study period, as defined below:
- WOCBP or females who have the last menstrual period within 12 months must have a negative serum or urine pregnancy test at Screening (Visit 1).
- Subjects who have voluntarily decided to take part in the study and able to comply with the study protocol
Key exclusion criteria (22 listed)
- Common
- Subjects who have received or treated with following medications within the specified timeframe prior to Screening (Visit 1) or who are expected to receive them during the study period:
- Subjects who have prior history of clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, hematology/neoplasm, cardiovascular system, mental (mood disorder, obsessive-compulsive disorder), gastrointestinal disorders or surgical history
- Subjects with acute fever > 37.5℃ within 7 days from the expected IP administration or showing symptoms suspecting acute diseases within 14 days from the expected IP administration
- Subjects who do not have normal blood pressure*
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 |
|---|---|---|
| ALT-BB4Recombinant Hyaluronidase | Drug | Part I (Allergy assessment) - ALT-BB4, Part II-A (PK assessment), Part II-B (Safety assessment) - ALT-BB4 |
| 0.9%NaClNormal Saline | Drug | Part I (Allergy assessment) - 0.9%NaCl, Part II-B (Safety assessment) - 0.9% NaCl |
Primary outcome
Incidence Rate of Drug Allergy Following ID Injection of the IP
Time frame: 2 days
Subject developing either immediate or delayed allergic reaction are considered to have drug allergy.
Injection-site TEAEs (Treatment Emergent Adverse Events)
Time frame: 4 weeks
Incident rate of administration site-related adverse events in Part Ⅱ-B
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40892310Lee JS, Kim W, Won CH, Lee YW, Lee S, Won H, Park SJ, Lee S, Kim SH, Yang J, Bahn G, Lee DH. The Safety, Tolerability, and Pharmacokinetics of ALT-BB4 (A Novel Recombinant Hyaluronidase): A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study in Healthy Volunteers. Dermatol Ther (Heidelb). 2025 Nov;15(11):3301-3311. doi: 10.1007/s13555-025-01507-x. Epub 2025 Sep 2.
- Individual participant dataSharing planned: No. Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ALT-BB4 and 0.9%NaCl in people with Health, Subjective, run by Alteogen, Inc. 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 16 inclusion and 22 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 29 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 ID Injection of the IP (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05232175, which also lists 1 linked publication.
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 29 Jan 2026.