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NOT YET RECRUITING
NCT07484893
PHASE1

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

Sponsor: Shanghai Henlius Biotech

View on ClinicalTrials.gov

Summary

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

Official title: A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Chinese Adult Male Subjects

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-05-14

Completion Date

2026-10-24

Last Updated

2026-03-20

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China