Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
45
Countries
1
Sites
2
B-cell–mediated autoimmune diseases
Key facts
- Sponsor
- Oblenio Bio Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12]
- Decision date (initial)
- 2026-06-25
- 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
B-cell–mediated autoimmune diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061664 | Autoimmune disorder | 100000004870 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oblenio Bio Inc.
- Sponsor organisation
- Oblenio Bio Inc.
- Address
- 1111 Broadway Suite 1300
- City
- Oakland
- Postcode
- 94607-4091
- Country
- United States
Scientific contact point
- Organisation
- Oblenio Bio Inc.
- Contact name
- Tapan Maniar, MD
Public contact point
- Organisation
- Oblenio Bio Inc.
- Contact name
- Christine Cornwell
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 45 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-31 | Germany | Acceptable 2026-06-24
|
2026-06-25 |