A Clinical Trial of Safety and Tolerance of TQH3821 Tablets in Adult Healthy Subjects

NCT05380934 | Completed Phase 1

• 1 other identifier: TQH3821-I-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a randomized, double-blind, placebo-controlled phase I clinical trial of TQH3821 in adult healthy subjects, which plans to recruit 72 healthy subjects. The main purpose was to evaluate the safety and tolerance of different doses of TQH3821 or in combination with methotrexate tablets after single and multiple administration in healthy subjects.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  Safety and tolerability are assessed by the incidence of adverse events and its severity caused by the study drug during or after dose.

  The first day of the first administration until 8 days after the last administration

Secondary Outcomes (4)

• Peak concentration (Cmax)

  Pharmacokinetics blood samples were collected from 60 minutes before administration on Day 1 to 168 hours after the last administration.

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

  Pharmacokinetics blood samples were collected from 60 minutes before administration on Day 1 to 168 hours after the last administration.

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

  Pharmacokinetics blood samples were collected from 60 minutes before administration on Day 1 to 168 hours after the last administration.

• High sensitivity C-reactive protein (hs-CRP)

  Multiple Administration Dose: Blood samples were collected from 60 minutes before administration on Day 1 to 192 hours after the consecutive administration.

Study Arms (8)

TQH3821 Tablets (Single Administration Dose)

EXPERIMENTAL

TQH3821 tablets, Single administration

Drug: TQH3821 tablets

TQH3821 Placebo Tablets (Single Administration Dose)

PLACEBO COMPARATOR

TQH3821 placebo tablets, Single administration

Drug: TQH3821 tablets (Placebo)

TQH3821 Tablets (Food Effect)

EXPERIMENTAL

TQH3821 tablets, 2 sequential periods (fasting and fed)

Drug: TQH3821 tablets

TQH3821 Placebo Tablets (Food Effect)

PLACEBO COMPARATOR

TQH3821 placebo tablets, 2 sequential periods (fasting and fed)

Drug: TQH3821 tablets (Placebo)

TQH3821 Tablets (Multiple Administration Dose)

EXPERIMENTAL

TQH3821 tablets once every 12 hours for 7 times during the continuous administration phase.

Drug: TQH3821 tablets

TQH3821 Placebo Tablets (Multiple Administration Dose)

PLACEBO COMPARATOR

TQH3821 placebo tablets once every 12 hours for 7 times during the continuous administration phase.

Drug: TQH3821 tablets (Placebo)

TQH3821 Tablets + Methotrexate Tablets

EXPERIMENTAL

Take Methotrexate Tablets once in the first cycle, take TQH3821 Tablets once every 12 hours in the second cycle for 6 times, and then TQH3821 Tablets + Methotrexate Tablets once in the third cycle.

Drug: TQH3821 tablets; Drug: Methotrexate tablets

TQH3821 Placebo Tablets + Methotrexate Tablets

PLACEBO COMPARATOR

Take Methotrexate Tablets once in the first cycle, take TQH3821 placebo tablets once every 12 hours in the second cycle for 6 times, and then TQH3821 placebo tablets + Methotrexate Tablets once in the third cycle.

Drug: TQH3821 tablets (Placebo); Drug: Methotrexate tablets

Interventions

TQH3821 tablets DRUG

TQH3821 tablets is an Interleukin-1 receptor-associated kinase 4 inhibitor that exhibits a high degree of inhibitory activity against IRAK4 kinase.

TQH3821 Tablets (Food Effect); TQH3821 Tablets (Multiple Administration Dose); TQH3821 Tablets (Single Administration Dose); TQH3821 Tablets + Methotrexate Tablets

TQH3821 tablets (Placebo) DRUG

TQH3821 tablets (Placebo) is a placebo produced with reference to TQH3821 tablets, which has no effect on IRAK4 kinase.

TQH3821 Placebo Tablets (Food Effect); TQH3821 Placebo Tablets (Multiple Administration Dose); TQH3821 Placebo Tablets (Single Administration Dose); TQH3821 Placebo Tablets + Methotrexate Tablets

Methotrexate tablets DRUG

Methotrexate tablets is a folic acid antagonist, which belongs to an anti-rheumatic drug to improve the condition

TQH3821 Placebo Tablets + Methotrexate Tablets; TQH3821 Tablets + Methotrexate Tablets

Eligibility Criteria

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

You may qualify if:

• Sign an informed consent form before the test, and fully understand the content, process and possible adverse reactions of the test;
• Be able to complete the research according to the requirements of the plan;
• Subjects (including partners) are willing to voluntarily take effective contraception within 6 months from screening to the last study drug administration;
• Male and female subjects aged 18 to 55 years (including critical value);
• Male subjects weigh not less than 50 kg, female subjects weigh not less than 45 kg, BMI in the range of 18 \~ 28 kg / m2 (including critical value);
• Physical examination, normal or abnormal vital signs are of no clinical significance

You may not qualify if:

• Those who smoke more than 5 cigarettes per day in the 12 weeks before screening;
• Allergic constitution (a variety of drug and food allergies);
• Have a history of substance abuse, drug and/or alcohol abuse;
• Donate blood or lose a lot of blood (\> 450 mL) within 12 weeks prior to screening;
• Take any drug that alters the activity of liver enzymes 28 days before screening, or combined with inhibitors or inducers of Cytochrome P4503A4 enzyme (CYP3A4 );
• Took any prescription drugs, over-the-counter drugs, any vitamin products or herbs within 14 days prior to screening;
• Those who have taken a special diet or have strenuous exercise within 2 weeks before screening, or other factors that affect drug absorption, distribution, metabolism, excretion and other factors;
• Those who are vaccinated with live attenuated vaccines within 28 days before the start of research treatment, inactivated vaccines within 7 days, or vaccinated during the study period;
• Have taken research drugs within 12 weeks before taking our research drugs, or participated in clinical trials of drugs;
• Have a history of dysphagia or any gastrointestinal diseases that affect the absorption of the drug or a history of gallbladder resection or biliary tract diseases;
• Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
• Subjects who could not tolerate a standard meal; (only applies to subjects participating in the postprandial test);
• Electrocardiogram (ECG) abnormalities have clinical significance;
• Female subjects are breastfeeding during the screening period or during the test or have a positive serum pregnancy result;
• Diseases with abnormal clinical significance in clinical laboratory examination or other clinical findings within 24 weeks before screening;

Sponsors & Collaborators

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

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: May 16, 2022
• First Posted: May 19, 2022
• Study Start: May 29, 2022
• Primary Completion: May 20, 2023
• Study Completion: May 20, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

CN (1)