Healthy Adult MalePhase 1NCT07484893
A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects
A Phase 1 study testing recombinant human hyaluronidase in people with Healthy Adult Male, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- recombinant human hyaluronidase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2026to 24 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects, aged ≥ 18 and ≤ 45 years.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 28.0 kg/m².
- Intact skin at the injection site, with no damage, tattoos, or other markings.
- No significant medical history, or a history of abnormalities that, in the investigator's judgment, will not impact the study.
- Physical examination, vital signs, electrocardiogram (ECG), chest X-ray, and clinical laboratory tests are normal or abnormal without clinical significance (NCS).
- Subjects must agree to use highly effective contraception with their spouse or partner from the time of signing the Informed Consent Form (ICF) until 3 months after the last dose, or the subject is not capable of reproduction. Subjects must also refrain from sperm donation during the study and for 3 months following the last dose of the investigational product.
- Voluntarily signed the Informed Consent Form (ICF) prior to any study procedures, with a full understanding of the study content, procedures, and potential adverse events (AEs); and the ability to comply with the protocol requirements to complete the study.
Who cannot join
- History of drug abuse or or substance use, or a positive drug screen; history of long-term heavy alcohol consumption (defined as consuming more than 14 units of alcohol per week within 3 months prior to screening [1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine]) or a positive blood alcohol test; history of long-term heavy alcohol use or positive blood alcohol test; history of long-term heavy smoking (defined as an average of more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from smoking during the ).
- Cardiac disorders, including but not limited to clinically significant ECG abnormalities during the screening period, QTcF > 450ms, or a history of clinically significant ECG abnormalities.
- History of any clinically severe hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or oncological diseases, or allergic diseases.
- History of upper respiratory tract infection or other acute infections within 7 days prior to the first dose, or systemic use of antibiotics within 7 days.
- Known allergy to recombinant human hyaluronidase for injection or its formulation components; history of severe allergic reactions to any medication (e.g., angioedema); special dietary requirements or inability to comply with the standardized diet provided by the clinical site.
- Use of any prescription drugs, over-the-counter (OTC) medications, or herbal medicines within 4 weeks prior to screening (especially salicylates, cortisone, adrenocorticotropic hormone, estrogens, or antihistamines, except for routine vitamin supplements), or within 5 half-lives of the medication (whichever is longer).
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- Vaccination within 1 month prior to administration.
- History of blood donation or blood loss ≥ 400 mL within 3 months prior to the use of the investigational product.
- Participation in any other clinical study and use of investigational/control products within 3 months prior to the investigational product administration.
- Positive for HBsAg, anti-HCV, anti-HIV, or the syphilis spirochete test.
- Sensory-motor disorders or autonomic movement disorders.
- Any condition which, in the investigator's judgment, would make the subject unable to comply with the protocol requirements, instructions, or study restrictions, such as an uncooperative attitude, inability to return for follow-up visits, or inability to complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Wei Hu, +86 13856086475, hwgcp@ayefy.com
Qian Zhang, +86 13866147268, 1309091629@qq.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Chinese Adult Male Subjects
The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
- Conditions
- Healthy Adult Male
- Being tested
- recombinant human hyaluronidase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human hyaluronidaseDrug
HLXTE-HAase02 is a proprietary recombinant human hyaluronidase, with a molecular weight of approximately 49 kDa, is expressed in Chinese Hamster Ovary (CHO) cells and is intended for formulation development.
| Study group | Role | What they receive |
|---|---|---|
| HLXTE-HAase02, in healthy Chinese adult male subjects | Experimental | The study consists of three sequential dose-escalation cohorts, with a planned total of approximately 24 subjects (8 subjects per cohort). HLXTE-HAase02 will be administered via subcutaneous (SC) injection at a diluted concentration of 2000 U/mL. The three dose levels are 5 mL, 15 mL, and 25 mL. Each subject will receive the administration on D1 and D8. No intra-patient dose escalation is allowed. The safety of injection site reactions (ISRs) will be evaluated by the Safety Review Committee (SRC) based on their severity, incidence, and other factors to discuss the safety and determine the eligibility for escalation to the next dose level. Receives: Drug: recombinant human hyaluronidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety Endpoint
Measured: From enrollment to 21 days after the second dose
Incidence of hypersensitivity reactions
Safety Endpoint
Measured: From enrollment to 21 days after the second dose
Incidence of injection site reactions (ISRs)
Safety Endpoint
Measured: From enrollment to 21 days after the second dose
Secondary outcomes (10)
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
Pharmacokinetic (PK) parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Measured: From enrollment to 21 days after the second dose
Area under the concentration-time curve from time zero to to the last measurable concentration (AUC0-t)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Measured: From enrollment to 21 days after the second dose
Maximum serum concentration (Cmax)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Measured: From enrollment to 21 days after the second dose
Time to maximum serum concentration (Tmax)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Measured: From enrollment to 21 days after the second dose
Terminal elimination half-life (T1/2)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Measured: From enrollment to 21 days after the second dose
Terminal elimination rate constant (λz)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Measured: From enrollment to 21 days after the second dose
Extrapolation percentage of AUC (%AUCex)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Measured: From enrollment to 21 days after the second dose
Positive rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Immunogenicity
Measured: From enrollment to 21 days after the second dose
Subcutaneous injection rate (mL/min)
Injection-related indicators
Measured: From enrollment to 21 days after the second dose
Mean of triplicate abdominal circumference measurements
Injection-related indicators
Measured: From enrollment to 21 days after the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start14 May 2026 (estimated)
- Primary completion25 Aug 2026 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Hu, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484893
- Sponsor's protocol ID
- HLXTE-HAase02-FIH001
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Chinese Adult Male Subjects
- ClinicalTrials.gov ID
- NCT07484893
- Acronym / sponsor ID
- HLXTE-HAase02-FIH001
- Conditions
- Healthy Adult Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 14 May 2026 (estimated)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 20 Mar 2026 (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.
The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLXTE-HAase02, in healthy Chinese adult male subjects | Experimental | Drug: recombinant human hyaluronidaseThe study consists of three sequential dose-escalation cohorts, with a planned total of approximately 24 subjects (8 subjects per cohort). HLXTE-HAase02 will be administered via subcutaneous (SC) injection at a diluted concentration of 2000 U/mL. The three dose levels are 5 mL, 15 mL, and 25 mL. Each subject will receive the administration on D1 and D8. No intra-patient dose escalation is allowed. The safety of injection site reactions (ISRs) will be evaluated by the Safety Review Committee (SRC) based on their severity, incidence, and other factors to discuss the safety and determine the eligibility for escalation to the next dose level. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male subjects, aged ≥ 18 and ≤ 45 years.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 28.0 kg/m².
- Intact skin at the injection site, with no damage, tattoos, or other markings.
- No significant medical history, or a history of abnormalities that, in the investigator's judgment, will not impact the study.
- Physical examination, vital signs, electrocardiogram (ECG), chest X-ray, and clinical laboratory tests are normal or abnormal without clinical significance (NCS).
Key exclusion criteria (12 listed)
- History of drug abuse or or substance use, or a positive drug screen; history of long-term heavy alcohol consumption (defined as consuming more than 14 units of alcohol per week within 3 months prior to screening [1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine]) or a positive blood alcohol test; history of long-term heavy alcohol use or positive blood alcohol test; history of long-term heavy smoking (defined as an average of more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from smoking during the ).
- Cardiac disorders, including but not limited to clinically significant ECG abnormalities during the screening period, QTcF > 450ms, or a history of clinically significant ECG abnormalities.
- History of any clinically severe hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or oncological diseases, or allergic diseases.
- History of upper respiratory tract infection or other acute infections within 7 days prior to the first dose, or systemic use of antibiotics within 7 days.
- Known allergy to recombinant human hyaluronidase for injection or its formulation components; history of severe allergic reactions to any medication (e.g., angioedema); special dietary requirements or inability to comply with the standardized diet provided by the clinical site.
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 |
|---|---|---|
| recombinant human hyaluronidaseHLXTE-HAase02 is a proprietary recombinant human hyaluronidase, with a molecular weight of approximately 49 kDa, is expressed in Chinese Hamster Ovary (CHO) cells and is intended for formulation development. | Drug | HLXTE-HAase02, in healthy Chinese adult male subjects |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From enrollment to 21 days after the second dose
Safety Endpoint
Incidence of hypersensitivity reactions
Time frame: From enrollment to 21 days after the second dose
Safety Endpoint
Incidence of injection site reactions (ISRs)
Time frame: From enrollment to 21 days after the second dose
Safety Endpoint
10 secondary outcomes
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
Time frame: From enrollment to 21 days after the second dose
Area under the concentration-time curve from time zero to to the last measurable concentration (AUC0-t)
Time frame: From enrollment to 21 days after the second dose
Maximum serum concentration (Cmax)
Time frame: From enrollment to 21 days after the second dose
Time to maximum serum concentration (Tmax)
Time frame: From enrollment to 21 days after the second dose
Terminal elimination half-life (T1/2)
Time frame: From enrollment to 21 days after the second dose
Terminal elimination rate constant (λz)
Time frame: From enrollment to 21 days after the second dose
Extrapolation percentage of AUC (%AUCex)
Time frame: From enrollment to 21 days after the second dose
Positive rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Time frame: From enrollment to 21 days after the second dose
Subcutaneous injection rate (mL/min)
Time frame: From enrollment to 21 days after the second dose
Mean of triplicate abdominal circumference measurements
Time frame: From enrollment to 21 days after the second dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- 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.
Wei Hu principal investigator
The Second Hospital of Anhui Medical University
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 recombinant human hyaluronidase in people with Healthy Adult Male, run by Shanghai Henlius Biotech at 1 site in China.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 20 Mar 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Jin (+86 15955160489, qi_jin@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From enrollment to 21 days after the second dose). The study lists 3 primary outcomes in all. 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 20 Mar 2026.