A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B

NCT06452693 | Not Yet Recruiting Phase 1

• 1 other identifier: TQA3038-Ib/IIa-01
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 22

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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (3)

• Adverse events (AEs)

  The incidence of adverse events (AEs) during treatment.

  Baseline up to 16 weeks

• Serious adverse events (SAEs)

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

  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.

  Baseline up to 48 weeks

Secondary Outcomes (10)

• 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

• 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

• 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

• 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

Study Arms (2)

TQA3038 injection/placebo

EXPERIMENTAL

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.

Drug: TQA3038 injection/placebo

Nucleotide drugs Control group

ACTIVE COMPARATOR

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

Drug: Nucleotide drugs Control group

Interventions

TQA3038 injection/placebo DRUG

TQA3038 is a Anti-Hepatitis B virus (HBV) drugs.

TQA3038 injection/placebo

Nucleotide drugs Control group DRUG

Nucleotide drugs are nucleoside reverse transcriptase inhibitors.

Nucleotide drugs Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients with significant liver fibrosis or cirrhosis before or during screening;
• History of chronic liver diseases other than chronic HBV infection;
• Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;
• Used immunosuppressive or immunomodulatory drugs and cytotoxic drugs within 6 months prior to the study medication;
• During screening, subjects showed significant laboratory results abnormalities；

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (22)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233000, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350025, China

Location

Gansu province people hospital

Lanzhou, Gansu, 730030, China

Location

The Third Affiliated Hospital of Sun Yat sen University

Guangzhou, Guangdong, 510630, China

Location

The First Affiliated Hospital of GUANGXI Medical University

Nanning, Guangxi, 530021, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

Shiyan City Taihe Hospital

Shiyan, Hubei, 442000, China

Location

Tongji Hospital of Tongji medical college of HUST

Wuhan, Hubei, 430030, China

Location

Xiangya Third Hospital of Central of Central Suoth University

Changsha, Hunan, 410000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

The first hospital of Jilin University

Changchun, Jilin, 130061, China

Location

Hepatobiliary Hospital of Jilin

Changchun, Jilin, 130062, China

Location

The sixth people's hospital at of Shenyang

Shenyang, Liaoning, 110006, China

Location

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, 110136, China

Location

Shandong Public Health Clinical Center

Jinan, Shandong, 250102, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

The Southwest Hospital of AMU

Chongqing, 400038, China

Location

The Second Affilated Hospital of Chongqing medical university

Chongqing, 400080, China

Location

Shanghai Tongren Hospital

Shanghai, 200000, China

Location

People's Hospital of Tianjin (City)

Tianjin, 300000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qin Ning, Doctor

CONTACT

13971521450; qning@vip.sina.com

Junqi Niu, Doctor

CONTACT

13756661205; junqiniu@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 11, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-03

Locations

CN (22)