Trials / Not Yet Recruiting
Not Yet RecruitingNCT07484893
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Shanghai Henlius Biotech · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-05-14
- Primary completion
- 2026-08-25
- Completion
- 2026-10-24
- First posted
- 2026-03-20
- Last updated
- 2026-03-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07484893. Inclusion in this directory is not an endorsement.