This is a randomized, double-blinded, placebo-controlled, phase IIa study to evaluate safety and efficacy of TQ-A3334 combined with entecavir in the untreated or HBV DNA negative subjects with Chronic Hepatitis B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
12
TQ-A3334 is a kind of TLR7 receptor agonist.
Placebo is a treatment which is designed to have no therapeutic value.
Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.
The second affiliated hospital of chongqing medical university
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe first hospital of Jilin University
Changchun, Jinlin, China
RECRUITINGCmax
Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s).
Time frame: Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.
Tmax
To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration.
Time frame: Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.
AUC0-t
To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity.
Time frame: Hour 0, 5, 10, 20, 30 minutes, 1, 2 , 3 , 6 , 12, 24, 72 , 168 hours post-dose at week 1 and week 12; Hour 0 of week 4, week 7, week 9, week 11.
Cytokine
Including IFN-α, IFN-γ, TNF-α, IL-6, IL-2, MCP-1 and so on.
Time frame: Hour 0, 1.5 , 12 , 24 , 72 hours post-dose at week 1 and week 12; Hour 0 at week 7.
HBV biomarker
Including HBsAg, HBsAb, HBeAb, anti-HBc, HBV-DNA, HBV RNA and HBcrAg.
Time frame: Day 1 pre-dose, day 84, day 168, day 336 post-dose.
Lymphocyte function
Analysis of immune cell response to hepatitis B antigen after treatment.
Time frame: Hour 0 pre-dose, day 56, day 84, day 168 at post-dose.
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