Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
2
Adult polyglucosan body disease (APBD).
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, GHF-Golden Heart Flower Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 27 Jun 2025 → 19 Jan 2026
- Decision date (initial)
- 2025-04-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adult polyglucosan body disease (APBD).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10077946 | Adult polyglucosan body disease | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CCDRD Cooperative Clinical Drug Research and Development AG
- Sponsor organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Address
- Dahlwitz, Lindenallee 70, Dahlwitz-Hoppegarten Lindenallee 70 Dahlwitz-Hoppegarten
- City
- Hoppegarten
- Postcode
- 15366
- Country
- Germany
Scientific contact point
- Organisation
- GHF-Golden Heart Flower Ltd.
- Contact name
- Head of Product Development: Yossi Gilgun-Sherki
Public contact point
- Organisation
- GHF-Golden Heart Flower Ltd.
- Contact name
- Head of Product Development: Yossi Gilgun-Sherki
GHF-Golden Heart Flower Ltd.
- Sponsor organisation
- GHF-Golden Heart Flower Ltd.
- Address
- 4, Ha-Amal
- City
- Afula
- Postcode
- 1857109
- Country
- Israel
Scientific contact point
- Organisation
- GHF-Golden Heart Flower Ltd.
- Contact name
- Head of Product Development: Yossi Gilgun-Sherki, PhD, MBA
Public contact point
- Organisation
- GHF-Golden Heart Flower Ltd.
- Contact name
- Head of Product Development: Yossi Gilgun-Sherki, PhD, MBA
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 32 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2025-06-27 | 2026-01-19 | 2025-06-27 | 2025-12-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Bulgaria | Acceptable 2025-04-15
|
2025-04-17 |