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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
A Study to Evaluate the Safety and Efficacy of ZS801 in Adult Hemophilia B Patients
NCTID
NCT05641610
(View at clinicaltrials.gov)
Description
A non-randomized, open-label, dose-escalation, phase I/II study to evaluate the safety, tolerability, kinetics and efficacy of a single intravenous infusion of ZS801 in hemophilia B subjects with endogenous FIX ≤2%.
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Indication
Hemophilia B
Compound Name
ZS801
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Funder Type
Other
Status
Not yet recruiting
Enrollment Count
21
Therapy Information
Target Gene/Variant
F9
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Functional gene replacement
Route of Administration
Intravenous
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV
Editor Type
Dose 1
2.0 x 10^12 vg/kg
Dose 2
5.0 x 10^12 vg/kg
Dose 3
1.0 x 10^13 vg/kg
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1, Phase2
Submit Date
2022-11-25
Completion Date
2028-12
Last Update
2023-02-09
Participation Criteria
Eligible Age
>=18 Years
Standard Ages
Adult, Older adult
Eligible Sex
MALE
Locations
No.of Trial Sites
1
Locations
China
Regulatory Information
Has US IND
False
Recent Updates
Resources/Links
Resources/Links
No External Links Available.