Rheumatoid ArthritisPhase 1NCT05380934
A Clinical Trial of Safety and Tolerance of TQH3821 Tablets in Adult Healthy Subjects
A Phase 1 study testing TQH3821 tablets and Methotrexate tablets in people with Rheumatoid Arthritis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TQH3821 tablets and Methotrexate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2022to 20 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1 Sign an informed consent form before the test, and fully understand the content, process and possible adverse reactions of the test;
- 2 Be able to complete the research according to the requirements of the plan;
- 3 Subjects (including partners) are willing to voluntarily take effective contraception within 6 months from screening to the last study drug administration;
- 4 Male and female subjects aged 18 to 55 years (including critical value);
- 5 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);
- 6 Physical examination, normal or abnormal vital signs are of no clinical significance
Who cannot join
- 1 Those who smoke more than 5 cigarettes per day in the 12 weeks before screening;
- 2 Allergic constitution (a variety of drug and food allergies);
- 3 Have a history of substance abuse, drug and/or alcohol abuse;
- 4 Donate blood or lose a lot of blood (> 450 mL) within 12 weeks prior to screening;
- 5 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 );
- 6 Took any prescription drugs, over-the-counter drugs, any vitamin products or herbs within 14 days prior to screening;
Show all 21Show fewer
- 7 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;
- 8 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;
- 9 Have taken research drugs within 12 weeks before taking our research drugs, or participated in clinical trials of drugs;
- 10 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;
- 11 Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
- 12 Subjects who could not tolerate a standard meal; (only applies to subjects participating in the postprandial test);
- 13 Electrocardiogram (ECG) abnormalities have clinical significance;
- 14 Female subjects are breastfeeding during the screening period or during the test or have a positive serum pregnancy result;
- 15 Diseases with abnormal clinical significance in clinical laboratory examination or other clinical findings within 24 weeks before screening;
- 16 Positive screening for viral hepatitis (including hepatitis B and C), Acquired Immune Deficiency Syndrome (AIDS) antibodies, treponemal antibodies;
- 17 Acute illness or concomitant medication from the screening stage to the study of medication;
- 18 Chocolate, any caffeinated or xanthine-rich foods or beverages taken 24 hours before taking the study drug;
- 19 Have taken any products containing alcohol within 24 hours before taking the research medication;
- 20 Positive for urine drug screening;
- 21 Participants who were considered by the investigators to have other factors that were not suitable for this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of TQH3821 in Adult Healthy Subjects
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
- Being tested
- TQH3821 tablets, TQH3821 tablets (Placebo), Methotrexate tablets
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQH3821 tabletsDrug
TQH3821 tablets is an Interleukin-1 receptor-associated kinase 4 inhibitor that exhibits a high degree of inhibitory activity against IRAK4 kinase.
TQH3821 tablets (Placebo)Drug
TQH3821 tablets (Placebo) is a placebo produced with reference to TQH3821 tablets, which has no effect on IRAK4 kinase.
Methotrexate tabletsDrug
Methotrexate tablets is a folic acid antagonist, which belongs to an anti-rheumatic drug to improve the condition
| Study group | Role | What they receive |
|---|---|---|
| TQH3821 Tablets (Single Administration Dose) | Experimental | TQH3821 tablets, Single administration Receives: Drug: TQH3821 tablets |
| TQH3821 Placebo Tablets (Single Administration Dose) | Placebo comparator | TQH3821 placebo tablets, Single administration Receives: Drug: TQH3821 tablets (Placebo) |
| TQH3821 Tablets (Food Effect) | Experimental | TQH3821 tablets, 2 sequential periods (fasting and fed) Receives: Drug: TQH3821 tablets |
| TQH3821 Placebo Tablets (Food Effect) | Placebo comparator | TQH3821 placebo tablets, 2 sequential periods (fasting and fed) Receives: Drug: TQH3821 tablets (Placebo) |
| TQH3821 Tablets (Multiple Administration Dose) | Experimental | TQH3821 tablets once every 12 hours for 7 times during the continuous administration phase. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: TQH3821 tablets (Placebo); Drug: Methotrexate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The first day of the first administration until 8 days after the last administration
Secondary outcomes (4)
Peak concentration (Cmax)
Peak concentration (Cmax) refers to the highest blood drug concentration achieved after administration called blood drug peak concentration (referred to as peak concentration), which is related to the dose administered, the route of administration, the number of times of administration and the time of arrival
Measured: 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)
The area under the plasma concentration-time curve from the beginning of the first administration to the last measurable concentration point
Measured: 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-∞)
Extrapolated from the first administration to the area under the plasma concentration-time curve to infinity
Measured: 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)
Hypersensitive C-reactive protein is a kind of C-reactive protein in plasma. It is a non-specific marker of acute systemic inflammatory response synthesized by the liver
Measured: Multiple Administration Dose: Blood samples were collected from 60 minutes before administration on Day 1 to 192 hours after the consecutive administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start29 May 2022
- Primary completion20 May 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380934
- Sponsor's protocol ID
- TQH3821-I-01
- Status last verified
- Jan 2024
- First submitted
- 16 May 2022
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of TQH3821 in Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT05380934
- Acronym / sponsor ID
- TQH3821-I-01
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| TQH3821 Tablets (Single Administration Dose) | Experimental | Drug: TQH3821 tabletsTQH3821 tablets, Single administration |
| TQH3821 Placebo Tablets (Single Administration Dose) | Placebo comparator | Drug: TQH3821 tablets (Placebo)TQH3821 placebo tablets, Single administration |
| TQH3821 Tablets (Food Effect) | Experimental | Drug: TQH3821 tabletsTQH3821 tablets, 2 sequential periods (fasting and fed) |
| TQH3821 Placebo Tablets (Food Effect) | Placebo comparator | Drug: TQH3821 tablets (Placebo)TQH3821 placebo tablets, 2 sequential periods (fasting and fed) |
| TQH3821 Tablets (Multiple Administration Dose) | Experimental | Drug: TQH3821 tabletsTQH3821 tablets once every 12 hours for 7 times during the continuous administration phase. |
| TQH3821 Placebo Tablets (Multiple Administration Dose) | Placebo comparator | Drug: TQH3821 tablets (Placebo)TQH3821 placebo tablets once every 12 hours for 7 times during the continuous administration phase. |
| TQH3821 Tablets + Methotrexate Tablets | Experimental | Drug: TQH3821 tablets, Drug: Methotrexate tabletsTake 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. |
| TQH3821 Placebo Tablets + Methotrexate Tablets | Placebo comparator | Drug: TQH3821 tablets (Placebo), Drug: Methotrexate tabletsTake 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1 Sign an informed consent form before the test, and fully understand the content, process and possible adverse reactions of the test;
- 2 Be able to complete the research according to the requirements of the plan;
- 3 Subjects (including partners) are willing to voluntarily take effective contraception within 6 months from screening to the last study drug administration;
- 4 Male and female subjects aged 18 to 55 years (including critical value);
- 5 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);
Key exclusion criteria (21 listed)
- 1 Those who smoke more than 5 cigarettes per day in the 12 weeks before screening;
- 2 Allergic constitution (a variety of drug and food allergies);
- 3 Have a history of substance abuse, drug and/or alcohol abuse;
- 4 Donate blood or lose a lot of blood (> 450 mL) within 12 weeks prior to screening;
- 5 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 );
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQH3821 tabletsTQH3821 tablets is an Interleukin-1 receptor-associated kinase 4 inhibitor that exhibits a high degree of inhibitory activity against IRAK4 kinase. | Drug | TQH3821 Tablets (Food Effect), TQH3821 Tablets (Multiple Administration Dose), TQH3821 Tablets (Single Administration Dose), TQH3821 Tablets + Methotrexate Tablets |
| TQH3821 tablets (Placebo)TQH3821 tablets (Placebo) is a placebo produced with reference to TQH3821 tablets, which has no effect on IRAK4 kinase. | Drug | TQH3821 Placebo Tablets (Food Effect), TQH3821 Placebo Tablets (Multiple Administration Dose), TQH3821 Placebo Tablets (Single Administration Dose), TQH3821 Placebo Tablets + Methotrexate Tablets |
| Methotrexate tabletsMethotrexate tablets is a folic acid antagonist, which belongs to an anti-rheumatic drug to improve the condition | Drug | TQH3821 Placebo Tablets + Methotrexate Tablets, TQH3821 Tablets + Methotrexate Tablets |
Primary outcome
Adverse events (AEs)
Time frame: The first day of the first administration until 8 days after the last administration
Safety and tolerability are assessed by the incidence of adverse events and its severity caused by the study drug during or after dose.
4 secondary outcomes
Peak concentration (Cmax)
Time frame: 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)
Time frame: 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-∞)
Time frame: 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)
Time frame: Multiple Administration Dose: Blood samples were collected from 60 minutes before administration on Day 1 to 192 hours after the consecutive administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQH3821 tablets and Methotrexate tablets in people with Rheumatoid Arthritis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: The first day of the first administration until 8 days after the last administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.