Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
100
Countries
1
Sites
7
Graves’ disease
Key facts
- Sponsor
- Merida Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-05-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-523823-23-00
- ClinicalTrials.gov
- NCT07305818
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Graves’ disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10065624 | Graves-Basedow disease | 10014698 |
| 26.0 | PT | 10018706 | Graves´ disease | 10014698 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merida Biosciences Inc.
- Sponsor organisation
- Merida Biosciences Inc.
- Address
- 500 Technology Square Floor 8
- City
- Cambridge
- Postcode
- 02139-3521
- Country
- United States
Scientific contact point
- Organisation
- Merida Biosciences Inc.
- Contact name
- Merida Clinical Trials
Public contact point
- Organisation
- Merida Biosciences Inc.
- Contact name
- Merida Clinical Trials
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 28 | 7 |
| Rest of world
United Kingdom, United States
|
— | 72 | — |
Investigational sites
Area Sanitaria Da Coruna E Cee
Endocrinology, Lugar Jubias De Arriba Num 84, 15006, A Coruna
Hospital Quironsalud Barcelona
Endocrinology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Micancer Center S.L.P.
Endocrinology, Calle Del Doctor Roux 76 Planta 5, 08017, Barcelona
Hospital Universitario Virgen De La Victoria
Endocrinology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitario Marques De Valdecilla
Endocrinology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Virgen De La Macarena
Ohptalmology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
University Hospital Virgen Del Rocio S.L.
Endocrinology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-20 | Spain | Acceptable 2026-05-21
|
2026-05-22 |