Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) in Chronic Hepatitis B Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 8, 2018

Primary Completion Date

October 14, 2019

Study Completion Date

October 14, 2019

Conditions
Hepatitis B Virus (HBV)
Interventions
BIOLOGICAL

T101 Group

"Single Dose (SD) Cohort:~In each group, 3 of chronic hepatitis B patients will be subcutaneously injected with different dose level of T101 at 1.0E+9VP (Group1)/1.0E+10VP (Group2)/1.0E+11VP (Group 3) on D1.~Multiple Dose (MD) Cohort:~In each group, 9 of chronic hepatitis B patients will be subcutaneously injected with different dose level of T101 at 1.0E+10VP (Group1)/1.0E+11VP (Group2) on D1, D8, D15."

BIOLOGICAL

Placebo Group

"Single Dose (SD) Cohort:~3 of chronic hepatitis B patients will be subcutaneously injected with placebo on D1.~Multiple Dose (MD) Cohort:~6 of chronic hepatitis B patients will be subcutaneously injected with placebo on D1, D8, D15."

Trial Locations (1)

Unknown

The First Hospital of Jilin University, Changchun

All Listed Sponsors
lead

Tasly Tianjin Biopharmaceutical Co., Ltd.

INDUSTRY

NCT04168333 - Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) in Chronic Hepatitis B Patients | Biotech Hunter | Biotech Hunter