A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Heal… (NCT07484893) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects
China24 participantsStarted 2026-05-14
Plain-language summary
The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
Who can participate
Age range18 Years – 45 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 lo…
What they're measuring
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From enrollment to 21 days after the second dose
2
Incidence of hypersensitivity reactions
Timeframe: From enrollment to 21 days after the second dose
3
Incidence of injection site reactions (ISRs)
Timeframe: From enrollment to 21 days after the second dose