Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
176
Countries
1
Sites
3
Moderate to Severe Rheumatoid Arthritis
Key facts
- Sponsor
- Lifordi Immunotherapeutics Inc.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-01-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Moderate to Severe Rheumatoid Arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Lifordi Immunotherapeutics Inc.
- Sponsor organisation
- Lifordi Immunotherapeutics Inc.
- Address
- 1 Van De Graaff Drive Suite 400
- City
- Burlington
- Postcode
- 01803-5176
- Country
- United States
Scientific contact point
- Organisation
- Lifordi Immunotherapeutics Inc.
- Contact name
- Chief Medical Officer
Public contact point
- Organisation
- Lifordi Immunotherapeutics Inc.
- Contact name
- Chief Medical Officer
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 40 | 3 |
| Rest of world
Georgia, Moldova, Republic of, Ukraine, Australia
|
— | 136 | — |
Investigational sites
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Toruń, Ul. Stefana Batorego 18-22, 87-100, Torun
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Centrum Wsparcia Badań Klinicznych, Ul. Spartanska 1, 02-637, Warsaw
Klinika Reuma Park Sp. z o.o. S.K.
Centrum Medyczne Reuma Park, Aleja Wilanowska 333, 02-665, Warsaw
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-23 | Poland | Acceptable 2026-01-26
|
2026-01-30 |