Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-06-05 @ 8:09 AM
Study NCT ID:
NCT07484893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects
Sponsor:
Shanghai Henlius Biotech
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: