Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
92
Countries
1
Sites
4
Atopic Dermatitis
Key facts
- Sponsor
- Bambusa Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2025-11-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522918-23-00
- ClinicalTrials.gov
- NCT06808477
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
Bambusa Therapeutics Inc.
2
Total trials
Commercial
- Sponsor organisation
- Bambusa Therapeutics Inc.
- Address
- 22 Boston Wharf Road Floor 7
- City
- Boston
- Postcode
- 02210-3032
- Country
- United States
Scientific contact point
- Organisation
- Bambusa Therapeutics Inc.
- Contact name
- Thang Ho
Public contact point
- Organisation
- Bambusa Therapeutics Inc.
- Contact name
- Lisa Li
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 10 | 4 |
| Rest of world
China, New Zealand, Australia, United States
|
— | 82 | — |
Investigational sites
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Oddzial Dermatologii, Dermatologii Dzieciecej i Onkologicznej, Ul. Gen. Karola Kniaziewicza 1/5, 91-347, Lodz
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Klinika Dermatologii i Dermatologii Onkologicznej,, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska, Ul. Ul. Sliczna 13, 50-566, Wroclaw
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Dermatologii, Ul. Woloska 137, 02-507, Warsaw
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-31 | Poland | Acceptable 2025-11-17
|
2025-11-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-19 | Poland | Acceptable 2026-03-02
|
2026-03-07 |