Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
84
Countries
1
Sites
1
Glomerular kidney diseases with proteinuria
Key facts
- Sponsor
- Walden Biosciences Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Decision date (initial)
- 2026-01-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Glomerular kidney diseases with proteinuria
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10021263 | IgA nephropathy | 100000004857 |
| 21.1 | LLT | 10027170 | Membranous nephropathy | 10038359 |
| 20.1 | PT | 10018364 | Glomerulonephritis | 100000004857 |
| 27.1 | PT | 10067757 | Focal segmental glomerulosclerosis | 100000004857 |
| 27.1 | PT | 10001843 | Alport´s syndrome | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Walden Biosciences Inc.
- Sponsor organisation
- Walden Biosciences Inc.
- Address
- 1 Kendall Square Suite 7102
- City
- Cambridge
- Postcode
- 02139-1562
- Country
- United States
Scientific contact point
- Organisation
- Walden Biosciences Inc.
- Contact name
- Tom Miller
Public contact point
- Organisation
- Walden Biosciences Inc.
- Contact name
- Blaine McKee
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 84 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-06 | Italy | Acceptable 2026-01-27
|
2026-01-27 |