Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets

NCT06431438 | Completed Phase 1

• 1 other identifier: TQA3810-I-01
• Study Type: interventional
• Target: 759
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a single-center study, including randomized, double-blind, placebo-controlled, single-dose escalation study, multiple-dose study, food effect on pharmacokinetics and drug metabolism transformation study, drug interaction study. To evaluate the tolerability, pharmacokinetics and metabolic transformation of TQA3810 in healthy subjects after single or multiple doses of TQA3810, the drug-drug interactions between TQA3810 tablets and entecavir dispersible tablets, and the pharmacokinetic properties of TQA3810 tablets in combination.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  Occurrence of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded.

  From the subject signed the informed consent form to 30 days after the last dose

Secondary Outcomes (5)

• Cmax

  Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose

• Tmax

  Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose

• Half-life (t1/2)

  Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose

• AUC0-t

  Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose

• AUC0-∞

  Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose

Study Arms (10)

0.5mg single-dose

PLACEBO COMPARATOR

Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

Drug: TQA3810

1.0mg single-dose

PLACEBO COMPARATOR

Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

Drug: TQA3810

Food impact group

OTHER

Sixteen subjects were enrolled and all received the trial drug.

Drug: TQA3810

0.1mg single-dose

PLACEBO COMPARATOR

Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

Drug: TQA3810

0.3mg single-dose

PLACEBO COMPARATOR

Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

Drug: TQA3810

Drug interaction group

ACTIVE COMPARATOR

Sixteen subjects were enrolled and all received the trial drug.

Drug: TQA3810

0.1mg multiple dosing

PLACEBO COMPARATOR

Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

Drug: TQA3810

0.3mg multiple dosing

PLACEBO COMPARATOR

Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

Drug: TQA3810

0.5mg multiple dosing

PLACEBO COMPARATOR

Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

Drug: TQA3810

0.2mg multiple dosing

PLACEBO COMPARATOR

Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo.

Drug: TQA3810

Interventions

TQA3810 DRUG

TQA3810 is a small-molecule Toll-like receptor (TLR8) agonist

0.1mg multiple dosing; 0.1mg single-dose; 0.2mg multiple dosing; 0.3mg multiple dosing; 0.3mg single-dose; 0.5mg multiple dosing; 0.5mg single-dose; 1.0mg single-dose; Drug interaction group; Food impact group

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 before the trial, and fully understand the trial content, process and possible adverse reactions;
• Able to complete the study according to the requirements of the trial protocol;
• The participants (including their partners) are willing to voluntarily use effective contraceptive methods within 6 months from screening until the last dose of study drug, as detailed in the Appendix;
• Male and female subjects aged 18-55 years old (including 18 and 55 years old);
• The body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 18-28 kg/m2 (including the cut-off value);
• The physical examination and vital signs were normal or abnormal without clinical significance.

You may not qualify if:

• Smoking more than 5 cigarettes per day in the 3 months before the study;
• Allergic constitution (multi-drug and food allergy);
• A history of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 ml wine);
• Donation or massive blood loss (\> 400 mL) within 3 months before screening;
• Taking any drugs that alter liver enzyme activity 28 days before screening;
• Have taken any prescription medication, over-the-counter medication, any vitamin product or herbal medicine within 14 days before screening;
• Those who had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 2 weeks before screening, or had other factors affecting drug absorption, distribution, metabolism, and excretion;
• Combined with the following inhibitors or inducers of CYP3A4, P-gp, or Bcrp, such as itraconazole, ketoconazole, or dronedarone, within three months before taking the study drug;
• A recent major change in diet or exercise habits;
• Have taken a study drug or participated in a clinical trial of the drug within three months before taking the study drug;
• A history of dysphagia or any gastrointestinal disorder affecting drug absorption or a history of cholecystectomy or biliary tract disease;
• Have any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers;
• With severe systemic diseases and related medical history (including subjects with active or occult tuberculosis, a history of tuberculosis, or clinical manifestations suspected of tuberculosis), as well as immune system diseases and medical history;
• Had systemic or local infection within 2 months prior to screening, and were hospitalized for severe infection and/or required intravenous antibiotics;
• Subjects who were unable to tolerate a standard meal;

Sponsors & Collaborators

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

Study Sites (1)

Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

Nanjing, Jiangsu, 210008, 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

Study Design

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

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: October 1, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CN (1)