Clinical trial NCT06160895: A Clinical Trial of TQ-A3334 Tablet After Multiple Administration in Adult Subjects
Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TQ-A3334 Tablet After Multiple Doses in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* Potential blood collection difficulties, history of needle and blood sickness;
* Having any clear history of drug or food allergy, especially to ingredients similar to those of the study drug;
* Those who smoked more than 5 cigarettes/day or used an equivalent amount of nicotine or nicotine-containing products within 3 months prior to screening, or who were unable to discontinue the use of any tobacco-based products during the trial;
* Those who have a history of chronic alcohol abuse or who have consumed more than 14 units of alcohol per week within 3 months prior to screening or who are unable to abstain from alcohol for the duration of the test or who have a positive breathalyzer test for alcohol;
* Those with a history of drug abuse or a positive urine drug screen;
* Those who can not avoid xanthine-rich beverages or foods or other factors that may affect drug absorption, distribution, metabolism, excretion, etc., from at least 1 day prior to study dosing until the end of the study;
* Subjects who, in the opinion of the investigator, have other factors that were unsuitable for participation in this trial.

Primary outcomes:
measure: Incidence of adverse events (AE)
timeFrame: From patient enrollment to withdrawal, estimated to be around 1 month.
measure: Severity of adverse events (AE)
timeFrame: From patient enrollment to withdrawal, estimated to be around 1 month.
measure: Incidence of serious adverse events (SAE)
timeFrame: From patient enrollment to withdrawal, estimated to be around 1 month.
measure: Severity of serious adverse events (SAE)
timeFrame: From patient enrollment to withdrawal, estimated to be around 1 month.
measure: Tolerability after drug administration
timeFrame: From patient enrollment to withdrawal, estimated to be around 1 month.
Secondary outcomes:
measure: Peak Time (Tmax)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Peak concentration (Cmax)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Plasma concentration-area under time curve (AUC0-24)
timeFrame: From 60 minutes before administration on Day 1 to 24 hours after the last administration.
measure: Plasma concentration-area under time curve (AUC0-24)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Plasma concentration-area under time curve (AUC0-∞)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Apparent volume of distribution (Vd/F)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Clearance (CL/F)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Elimination half-life time (t1/2)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Time of maximum concentration under steady state (Tmax,ss)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Maximum concentration under steady state (Cmax, ss)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Minimum concentration under steady state (Cmin, ss)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Plasma concentration at steady state (Cav, SS)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Plasma concentration area under steady-state time curve (AUCss)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Accumulation Index (Rac)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Degree of fluctuation (DF)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Interferon-α concentration (IFN-α)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Interferon-stimulated gene concentration (ISG)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Interferon-gamma concentration (IFN-γ)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Tumor Necrosis Factor-α concentration (TNF-α)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Interleukin-6 concentration (IL-6)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Interleukin-2 concentration (IL-2)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Monocyte Chemotactic Protein 1 concentration (MCP-1)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: Interferon-inducible protein-10 concentration (IP-10)
timeFrame: From 60 minutes before administration on Day 1 to 72 hours after the last administration.
measure: QT/QT interval
timeFrame: From 30 minutes before administration on Day 1 to 48 hours after the last administration.
Other outcomes:
Locations:
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
Study officials:
References: