Clinical Trials/NCT06452693

NCT06452693

Not yet recruiting

Phase 1

A Phase Ib/IIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.22 sites in 1 country162 target enrollmentJune 2024

ConditionsHepatitis B, Chronic

InterventionsTQA3038 injection/placebo Nucleotide drugs Control group

DrugsTQA3038 injection/placebo Nucleotide drugs Control group

Overview

Phase: Phase 1
Intervention: TQA3038 injection/placebo
Conditions: Hepatitis B, Chronic
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 162
Locations: 22
Primary Endpoint: Serious adverse events (SAEs)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2024

End Date

September 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects voluntarily participate in this study and sign informed consent;
•Male and female ≥18 years old and ≤65 years old;
•Male subjects with a weight of ≥ 50 kilograms and female subjects with a weight of ≥ 45 kilograms, BMI 18\~28 kg/m2;
•Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive ; During the screening period, 100 IU/ml ≤ HBsAg quantification ≤ 5000 IU/ml;
•The subjects are able to communicate well with the researchers, voluntarily and can understand and follow the experimental protocol process to complete the study;
•The subjects (including partners) are willing to voluntarily adopt effective contraceptive measures during the clinical trial period and long-term follow-up period, and specific contraceptive measures are shown in the appendix;
•The treated patients need to meet the condition:The subject must have received oral nucleoside (acid) drug treatment and a stable treatment regimen;
•Newly treated patients must meet the condition:During screening, the subjects had never received antiviral treatment for chronic hepatitis B B (oral nucleoside (acid) drugs and interferon), or had irregular antiviral treatment in the past, but had not received any antiviral treatment for chronic hepatitis B 3 months before enrollment.

Exclusion Criteria

•Pregnant and lactating women;
•Chronic diseases other than chronic HBV infection with significant clinical significance that have a history of mental illness or are deemed unsuitable by researchers for participation in this study;
•Acute diseases with significant clinical significance occurring within 7 days prior to receiving the investigational drug;
•Individuals with a history of active pathological bleeding or a tendency towards bleeding;
•Prescription medication has been used within 14 days prior to receiving the study drug;
•Receive any preventive or attenuated vaccines within 14 days prior to receiving the study drug;
•Blood donors or those who have lost a significant amount of blood within the first 3 months of screening, or those who have donated blood during the planned study period;
•Subjects with a history of excessive alcohol consumption;
•A history of alcohol or drug abuse within the 12 months prior to screening, or a positive drug screening result during screening;
•Complicated with other infected disease;

Arms & Interventions

TQA3038 injection/placebo

100/0mg\~400/0mg, subcutaneous injection, 2 weeks\~8 weeks as a cycle, a total of 2 doses. Nucleotide drugs: Oral, once a day, orally administered with food, for 16 weeks.

Intervention: TQA3038 injection/placebo

Nucleotide drugs Control group

Nucleotide drugs: Oral, once a day, orally administered with food, for 48weeks.

Intervention: Nucleotide drugs Control group

Outcomes

Primary Outcomes

Serious adverse events (SAEs)

Time Frame: Baseline up to 16 weeks

The incidence of serious adverse events (SAEs) during treatment.

Hepatitis B virus surface antigen (HbsAg)

Time Frame: Baseline up to 48 weeks

Changes of serum HbsAg compared with baseline at the 48th week of treatment in each group.

Adverse events (AEs)

Time Frame: Baseline up to 16 weeks

The incidence of adverse events (AEs) during treatment.

Secondary Outcomes

Maximum Plasma Concentration (Cmax)(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)
Time to Reach Maximum Plasma Concentration (Tmax)(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)(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)(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)
Hepatitis B surface antigen (HBsAg)(Baseline up to 48 weeks)
Hepatitis B E antigen (HBeAg)(Baseline up to 48 weeks)
Area Under the Plasma Concentration Versus Time Curve (AUC)(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)(Day1 before administration, Week 8, Week 16, and during withdrawal)
Incidence of Neutralization antibody (Nab)(Day1 before administration, Week 8, Week 16, and during withdrawal)
Apparent Terminal Elimination Half-life (t1/2)(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)