A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Male
• Intervention / Treatment: Drug: recombinant human hyaluronidase

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qi Jin; Phone Number: +86 15955160489; Email: qi_jin@henlius.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The Second Affiliated Hospital of Anhui Medical University
      • Contact: Wei Hu; Phone Number: +86 13856086475; Email: hwgcp@ayefy.com
      • Contact: Qian Zhang; Phone Number: +86 13866147268; Email: 1309091629@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HLXTE-HAase02, in healthy Chinese adult male subjects; 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.

Drug: recombinant human hyaluronidase; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Safety Endpoint	From enrollment to 21 days after the second dose
Incidence of hypersensitivity reactions	Safety Endpoint	From enrollment to 21 days after the second dose
Incidence of injection site reactions (ISRs)	Safety Endpoint	From enrollment to 21 days after the second dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	From enrollment to 21 days after the second dose
Positive rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)	Immunogenicity	From enrollment to 21 days after the second dose
Subcutaneous injection rate (mL/min)	Injection-related indicators	From enrollment to 21 days after the second dose
Mean of triplicate abdominal circumference measurements	Injection-related indicators	From enrollment to 21 days after the second dose

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech
• Investigators: Principal Investigator: Wei Hu, The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 14, 2026
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): October 24, 2026

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HLXTE-HAase02-FIH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No