Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
42
Countries
1
Sites
5
Atopic Dermatitis
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2026-06-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-524150-34-00
- ClinicalTrials.gov
- NCT06564389
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Atopic Dermatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003639 | Atopic dermatitis | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 19 | 5 |
| Rest of world
United States
|
— | 23 | — |
Investigational sites
Zdybski Med Sp. z o.o.
Dermatology, Ul. Klonowa 107/lu7, 25-553, Kielce
LASER CLINIC s.c. dr T. Kochanowski dr A. Królicki
Dermatology, Al. Piastów 65/U5, 70-322, Szczecin
M2M Med. Badania Sp. z o.o.
Dermatology, Ul. Lwowska 34, 41-500, Chorzow
Centrum Medyczne Angelius Provita
Dermatology, ul. Fabryczna 15b, 40-611, Katowice
Dermoklinika-Centrum Medyczne Spółka Cywilna M.kierstan J.narbutt A.lesiak
Dermatology, Aleja T. Kosciuszki 93, 90-436, Lodz
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-03 | Poland | Acceptable with conditions 2026-06-15
|
2026-06-18 |