This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of TQA3038 injection in patients with chronic hepatitis B. It is expected to include 72 subjects. Phase IIa adopted an open-label, randomized, parallel-controlled design, with a total of 90 subjects included, mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
162
TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.
Nucleotide drugs are nucleoside reverse transcriptase inhibitors.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Gansu province people hospital
Lanzhou, Gansu, China
The Third Affiliated Hospital of Sun Yat sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of GUANGXI Medical University
Nanning, Guangxi, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Shiyan City Taihe Hospital
Shiyan, Hubei, China
Tongji Hospital of Tongji medical college of HUST
Wuhan, Hubei, China
Xiangya Third Hospital of Central of Central Suoth University
Changsha, Hunan, China
...and 12 more locations
Adverse events (AEs)
The incidence of adverse events (AEs) during treatment.
Time frame: Baseline up to 16 weeks
Serious adverse events (SAEs)
The incidence of serious adverse events (SAEs) during treatment.
Time frame: Baseline up to 16 weeks
Hepatitis B virus surface antigen (HbsAg)
Changes of serum HbsAg compared with baseline at the 48th week of treatment in each group.
Time frame: Baseline up to 48 weeks
Time to Reach Maximum Plasma Concentration (Tmax)
Time to reach Cmax of TQA3038 and its metabolite in plasma.
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Maximum Plasma Concentration (Cmax)
Maximum concentration of TQA3038 and its metabolite in plasma.
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Area Under the Plasma Concentration Versus Time Curve (AUC)
Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time.
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Volume of distribution (Vd/F)
Volume of distribution (Vd/F) of TQA3038 in Plasma.
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Apparent Plasma Clearance (CL/F)
Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma.
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
Apparent Terminal Elimination Half-life (t1/2)
Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma
Time frame: Predose on the 1st dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose and Predose on the 2nd dose administration and 30 minutes, 1, 2, 4, 8, 24hours postdose
The incidence and titer of anti drug antibodies (ADA)
The incidence and titer of anti drug antibodies (ADA) in serum.
Time frame: Day1 before administration, Week 8, Week 16, and during withdrawal
Incidence of Neutralization antibody (Nab)
Incidence of Neutralization antibody (Nab) in serum.
Time frame: Day1 before administration, Week 8, Week 16, and during withdrawal
Hepatitis B surface antigen (HBsAg)
Changes in Hepatitis B surface antigen (HbsAg) levels from baseline during the study period.
Time frame: Baseline up to 48 weeks
Hepatitis B E antigen (HBeAg)
Changes in HbeAg levels from baseline during the study period.
Time frame: Baseline up to 48 weeks
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