A Randomized, Double-blinded, Placebo-controlled, Phase IIa Study of TQ-A3334 Combined With Entecavir in the Treatment of Untreated or HBV DNA Negative Subjects With Chronic Hepatitis B
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Cmax
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 and 65 years old ;
- •HBsAg positive at least for 6 months ;
- •HBeAg positive chronic hepatitis B, HBV DNA > 10^5 copies/ml;
- •Fibroscan ≤ 12.4 Kpa，2×ULN ≤ ALT ≤ ULN;
- •New diagnosed chronic hepatitis B subjects;
Exclusion Criteria
- •1.Combined with other virus infection ; 2.Has cirrhosis or hepatocellular carcinoma; 3.Has autoimmune diseases; 4.Has thyroid disease; 5.Has eye diseases; 6.Has clinically significant abnormalities/diseases ≥ grade 2; 7.Has history of chronic kidney disease, renal insufficiency, renal anemia; 8.Peripheral blood index is low; 9.Has a history of allergy to experimental drugs or their excipients; 10.Has participated in other clinical trials within 3 months; 11.Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study; 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.; 13.Has history of drug abuse in the past five years;
Arms & Interventions
TQ-A3334 combined with entecavir
Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks
Intervention: TQ-A3334 (Drug)
TQ-A3334 combined with entecavir
Subjects receive TQ-A3334 (1.2 mg QW) and entecavir (0.5 mg qd) in 24 weeks
Intervention: Entecavir Tablet (Drug)
Placebo combined with entecavir
Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks
Intervention: Placebo (Drug)
Placebo combined with entecavir
Subjects receive placebo (0 mg QW) and entecavir (0.5 mg qd) in 24 weeks
Intervention: Entecavir Tablet (Drug)
Outcomes
Primary Outcomes
Cmax
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.
Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s).
Tmax
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.
To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration.
AUC0-t
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.
To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity.
Cytokine
Time Frame: Hour 0, 1.5 , 12 , 24 , 72 hours post-dose at week 1 and week 12; Hour 0 at week 7.
Including IFN-α, IFN-γ, TNF-α, IL-6, IL-2, MCP-1 and so on.
Secondary Outcomes
- HBV biomarker(Day 1 pre-dose, day 84, day 168, day 336 post-dose.)
- Lymphocyte function(Hour 0 pre-dose, day 56, day 84, day 168 at post-dose.)