A Clinical Trial of TQ-A3334 Tablet After Multiple Administration in Adult Subjects

NCT06160895 | Completed Phase 1

• 1 other identifier: TQ-A3334-I-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo-controlled Phase I clinical study of TQ-A3334 tablets in adult healthy subjects, and the trial is planned to enroll 60 healthy subjects. The primary objective is to evaluate the safety and tolerability of multiple dosing of TQ-A3334 tablets in healthy subjects.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events (AE)

  Incidence of adverse events (AE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  From patient enrollment to withdrawal, estimated to be around 1 month.

• Severity of adverse events (AE)

  Severity of adverse events (AE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  From patient enrollment to withdrawal, estimated to be around 1 month.

• Incidence of serious adverse events (SAE)

  Incidence of serious adverse events (SAE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  From patient enrollment to withdrawal, estimated to be around 1 month.

• Severity of serious adverse events (SAE)

  Severity of serious adverse events (SAE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  From patient enrollment to withdrawal, estimated to be around 1 month.

• Tolerability after drug administration

  Tolerability is evaluated by the number of participants with abnormal laboratory examinations, vital signs, physical examination, electrocardiogram.

  From patient enrollment to withdrawal, estimated to be around 1 month.

Secondary Outcomes (24)

• Peak Time (Tmax)

  From 60 minutes before administration on Day 1 to 72 hours after the last administration.

• Peak concentration (Cmax)

  From 60 minutes before administration on Day 1 to 72 hours after the last administration.

• Plasma concentration-area under time curve (AUC0-24)

  From 60 minutes before administration on Day 1 to 24 hours after the last administration.

• Plasma concentration-area under time curve (AUC0-24)

  From 60 minutes before administration on Day 1 to 72 hours after the last administration.

• Plasma concentration-area under time curve (AUC0-∞)

  From 60 minutes before administration on Day 1 to 72 hours after the last administration.

Study Arms (6)

TQ-A3334 tablets (once a day)

EXPERIMENTAL

TQ-A3334 tablets, administered once a day.

Drug: TQ-A3334 tablets

TQ-A3334 placebo tablets (once a day)

PLACEBO COMPARATOR

TQ-A3334 placebo tablets, administered once a day.

Drug: TQ-A3334 placebo tablets

TQ-A3334 tablets (every other day)

EXPERIMENTAL

TQ-A3334 tablets, administered once every other day.

Drug: TQ-A3334 tablets

TQ-A3334 placebo tablets (every other day)

PLACEBO COMPARATOR

TQ-A3334 placebo tablets, administered once every other day.

Drug: TQ-A3334 placebo tablets

TQ-A3334 tablets (every three days)

EXPERIMENTAL

TQ-A3334 tablets, administered once every three days.

Drug: TQ-A3334 tablets

TQ-A3334 placebo tablets (every three days)

PLACEBO COMPARATOR

TQ-A3334 placebo tablets, administered once every three days.

Drug: TQ-A3334 placebo tablets

Interventions

TQ-A3334 tablets DRUG

TQ-A3334 tablet is a Toll like receptor 7 (TLR7) agonist.

TQ-A3334 tablets (every other day); TQ-A3334 tablets (every three days); TQ-A3334 tablets (once a day)

TQ-A3334 placebo tablets DRUG

TQ-A3334 placebo tablet is a placebo that has no effect on TLR7.

TQ-A3334 placebo tablets (every other day); TQ-A3334 placebo tablets (every three days); TQ-A3334 placebo tablets (once a day)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent form before the study, and fully understand the study content, process and possible adverse events;
• Be able to complete the study according to the requirements of the protocol;
• Male and female subjects aged 18 to 55 years (inclusive);
• Male subjects weigh not less than 50 kg, female subjects weigh not less than 45 kg, Body Mass Index (BMI) in the range of 18 \~ 28 kg/m2 (inclusive);
• No clinically significant medical history of cardiac, hepatic, renal, gastrointestinal, neurological, respiratory, psychiatric abnormalities and metabolic abnormalities;
• Subjects (including partners) are willing to voluntarily take effective contraception within 2 weeks before screening to 6 months after the last dose of study drug.

You may not qualify if:

• Female subjects who are breastfeeding or plan to conceive or have a positive serum pregnancy results during the screening or study period;
• A pre-existing or current neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hematologic-lymphatic, hepatic or renal insufficiency, endocrine, or musculoskeletal disease or other condition which, in the judgment of the Investigator, may have an effect on drug metabolism or safety;
• Eye diseases, including fundus lesions;
• History of clinically significant infections, including upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI), requiring antibiotic or antiviral medication within 14 days prior to screening or during screening;
• Acute illness or concomitant medication from the screening phase until study drug administration;
• History of dysphagia or any gastrointestinal disorder that interferes with drug absorption;
• Abnormal and clinically significant findings on vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, abdominal ultrasound, and chest radiographs during the screening period;
• Positive for HBsAg in Hepatitis B, Hepatitis C, Syphilis, and Human Immunodeficiency Virus (HIV) antigen/antibody;
• Have taken any medication that can alter liver drug enzyme activity within 28 days prior to screening;
• Received immunoglobulin or blood product therapy within 30 days prior to screening;
• Have taken an investigational drug or participated in a clinical trial of any drug within 3 months prior to screening;
• Have taken Any prescription, over-the-counter, vitamin product, or herbal medication within 2 weeks prior to screening;
• Use of any systemic cytotoxic or systemic immunosuppressive drug within 6 months prior to screening or during the study period, or use of any localized cytotoxic or localized immunosuppressive drug within 30 days or 5 half-lives, whichever is longer, prior to screening or during the study period;
• Have undergone surgery within 4 weeks prior to screening or who plan to undergo surgery during the study period;
• Have lost blood or donated more than 400 mL of blood within 2 months prior to screening;

Sponsors & Collaborators

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

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

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

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 7, 2023
• Study Start: December 26, 2023
• Primary Completion: June 24, 2024
• Study Completion: August 19, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

CN (1)