Clinical trial • Phase I • Nephrology

WAL0623 for Glomerular kidney disease with proteinuria|IgA nephropathy|Membranous nephropathy|Glomerulonephritis|Focal segmental glomerulosclerosis|Alport syndrome

Phase I trial of WAL0623 for Glomerular kidney disease with proteinuria|IgA nephropathy|Membranous nephropathy|Glomerulonephritis|Focal segmental glomerul…

Overview

Trial Therapeutic Area
Nephrology
Trial Disease
Glomerular kidney disease with proteinuria|IgA nephropathy|Membranous nephropathy|Glomerulonephritis|Focal segmental glomerulosclerosis|Alport syndrome
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
06-10-2025
First CTIS Authorization Date
27-01-2026

Trial design

Phase I trial across 1 site in Italy.

Target Sample Size
84

Eligibility

Recruits 84 Vulnerable population not selected; trial population listed as Healthy volunteers; no consent or assent handling for vulnerable populations specified..

Vulnerable Population
Vulnerable population not selected; trial population listed as Healthy volunteers; no consent or assent handling for vulnerable populations specified.

Recruitment

Planned Sample Size
84
Recruitment Window Months
12

Geography

Total Number Of Sites
1
Total Number Of Participants
84

Italy

Earliest CTIS Part Ii Submission Date
23-12-2025
Latest Decision Or Authorization Date
27-01-2026
Processing Time Days
35
Number Of Sites
1
Number Of Participants
84

Sites

Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Contact Person Name
Luigi Ziviani
Contact Person Email
luigi.ziviani@crc.vr.it

Sponsor

Primary sponsor

Full Name
Walden Biosciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
WAL0623

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