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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorShanghai Henlius Biotech

About this trial

The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • recombinant human hyaluronidase

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators