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Clinical Trial Report

Gene Therapy Trial Report

Summary

Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction


NCTID NCT06061549 (View at clinicaltrials.gov)
Description
Indication Heart Failure with Preserved Ejection Fraction
Compound Name AAV1-CMV-SERCA2a (SRD-001)
Sponsor Sardocor Corp.
Funder Type Industry
Status
Recruiting
Enrollment Count 10

Therapy Information


Target Gene/Variant SERCA2a
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intraarterial
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV1
Editor Type
Dose 1 3 x 10^13 vg
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1
Submit Date 2023-07-30
Completion Date 2029-08
Last Update 2023-09-29

Participation Criteria


Eligible Age >=50 Years
Standard Ages Adult, Older adult
Eligible Sex ALL

Locations


No.of Trial Sites 2
Locations United States

Regulatory Information


Has US IND True
Recent Updates First patients dosed Q1 2024, product/indication combo granted Fast Track designation

Resources/Links