Clinical trial • Phase I • Infectious Disease

DF-006 for Chronic Hepatitis B

Phase I trial of DF-006 for Chronic Hepatitis B. Randomised, placebo (dose/schedule not specified)-controlled. 107 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Chronic Hepatitis B
Trial Stage
Phase I
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
05-12-2023
First CTIS Authorization Date
16-04-2024

Trial design

Randomised, placebo (dose/schedule not specified)-controlled Phase I trial across 2 sites in Romania, Bulgaria.

Randomised
Yes
Comparator
Placebo (dose/schedule not specified)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
107

Recruitment

Planned Sample Size
107
Recruitment Window Months
7

Geography

Total Number Of Sites
2
Total Number Of Participants
12

Romania

Earliest CTIS Part Ii Submission Date
14-03-2024
Latest Decision Or Authorization Date
16-04-2024
Processing Time Days
33
Number Of Sites
1
Number Of Participants
7

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Ophthalmology Building, 1st floor, wards 33, 34, and 35
Contact Person Name
Adriana Bintintan
Contact Person Email
abintintan@yahoo.com
Number Of Participants
7

Bulgaria

Earliest CTIS Part Ii Submission Date
03-04-2024
Latest Decision Or Authorization Date
17-04-2024
Processing Time Days
14
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Multiprofile Hospital for Active Treatment Sveta Sofia
Department Name
Internal Medicine
Contact Person Name
Vesselin Koltchakov
Number Of Participants
5

Sponsor

Primary sponsor

Full Name
Zhejiang Yaoyuan Biotechnology Co. Ltd.
Organisation Type
Pharmaceutical company
Country Of Registered Address
China

Investigational products

Investigational Product Name
DF-006
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
First In Human
Yes

Related trials

Other published trials that may interest you.