Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
48
Countries
1
Sites
3
Graves Disease
Key facts
- Sponsor
- Lycia Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 2 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-06
- 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
Graves Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | PT | 10018706 | Graves´ disease | 10014698 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Lycia Therapeutics Inc.
- Sponsor organisation
- Lycia Therapeutics Inc.
- Address
- 400 East Jamie Court Suite 200
- City
- South San Francisco
- Postcode
- 94080-6229
- Country
- United States
Scientific contact point
- Organisation
- Lycia Therapeutics Inc.
- Contact name
- Nadia Tchao
Public contact point
- Organisation
- Lycia Therapeutics Inc.
- Contact name
- Lynne Georgopoulos
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 48 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
CTC Netherlands B.V.
CTC, Hanzeplein 1, 9713 GZ, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Endocrinology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Brain Research Center Den Bosch B.V.
Internal medicine/ endocrinology, Statenlaan 37, 5223 LA, 's-Hertogenbosch
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2026-04-02 | 2026-05-18 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-17 | Netherlands | Acceptable 2026-02-18
|
2026-03-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-17 | Netherlands | Acceptable 2026-02-18
|
2026-03-17 |