Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
50
Countries
2
Sites
3
chronic hepatitis B virus infection (cHBV)
Key facts
- Sponsor
- Assembly Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- completed 14 May 2025
- Decision date (initial)
- 2024-07-30
- 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 virus infection (cHBV)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assembly Biosciences Inc.
- Sponsor organisation
- Assembly Biosciences Inc.
- Address
- 2 Tower Place
- City
- South San Francisco
- Postcode
- 94080-1826
- Country
- United States
Scientific contact point
- Organisation
- Assembly Biosciences Inc.
- Contact name
- Chief Medical Officer
Public contact point
- Organisation
- Assembly Biosciences Inc.
- Contact name
- Chief Medical Officer
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 7 | 1 |
| Romania | Ended | 15 | 2 |
| Rest of world
Moldova, Republic of, New Zealand
|
— | 28 | — |
Investigational sites
Multiprofile Hospital for Active Treatment Sveta Sofia
Gastroenterology, Bulevard Bilgariya 104, 1404, Sofiya
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
Pavilion 1, wards: 2, 3, 4, 5, Strada Dr. Calistrat Grozovici Nr. 1, 021105, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Ophthalmology Building, 1st floor, wards: 33, 34, 35, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-23 | Romania | Acceptable with conditions 2024-07-29
|
2024-07-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-16 | Romania | Acceptable 2024-09-23
|
2024-09-25 |