Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
119
Countries
2
Sites
2
Chronic Hepatitis B
Key facts
- Sponsor
- Zhejiang Yaoyuan Biotechnology Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2024-04-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic Hepatitis B
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zhejiang Yaoyuan Biotechnology Co. Ltd.
- Sponsor organisation
- Zhejiang Yaoyuan Biotechnology Co. Ltd.
- Address
- Building D7, 555 Chuangye Road, Pinghu 555 Chuangye Road Pinghu
- City
- Jiaxing
- Postcode
- 314203
- Country
- China
Scientific contact point
- Organisation
- Zhejiang Yaoyuan Biotechnology Co. Ltd.
- Contact name
- Eshwari Kovoor
Public contact point
- Organisation
- Zhejiang Yaoyuan Biotechnology Co. Ltd.
- Contact name
- Eshwari Kovoor
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 5 | 1 |
| Romania | Authorised, recruitment pending | 7 | 1 |
| Rest of world
Korea, Democratic People's Republic of, Ukraine, China, Taiwan, Moldova, Republic of
|
— | 107 | — |
Investigational sites
Multiprofile Hospital for Active Treatment Sveta Sofia
Internal Medicine, Bulevard Bilgariya 104, 1404, Sofiya
Spitalul Clinic Judetean De Urgenta Cluj
Ophthalmology Building, 1st floor, wards 33, 34, and 35, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-05 | Romania | Acceptable 2024-04-15
|
2024-04-16 |