Chronic Hepatitis BPhase 1NCT06431438
Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets
A Phase 1 study testing TQA3810 in people with Chronic Hepatitis B, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- TQA3810
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 759 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 20 Nov 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
- 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.
Who cannot join
- 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;
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- 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;
- An electrocardiogram (ECG) abnormalities have clinical significance;
- The female subjects were lactating or seropositive for pregnancy during the screening or test period;
- Clinically significant abnormalities on clinical examination or other clinical findings within 6 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, oncologic, pulmonary, immune, psychiatric, or cardio-cerebrovascular diseases);
- Clinically significant fundus lesions (symptomatic cotton-like fundus changes) and retinopathy;
- Viral hepatitis (including hepatitis B and C), AIDS antibody, treponema pallidum antibody positive;
- From the screening stage to the onset of acute illness or concomitant medication before study medication;
- Consumption of chocolate, any caffeinated or xanthine-rich food or beverage 24 hours before taking the study drug;
- Have taken any alcohol-based product within 24 hours before taking the study medication;
- Having a positive urine drug screen or having a history of drug abuse or drug use in the past 5 years;
- Subjects with other factors considered by the investigator to be ineligible for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing, Jiangsu, 210008
About this study
Official title: A Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets
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
- Being tested
- TQA3810
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQA3810Drug
TQA3810 is a small-molecule Toll-like receptor (TLR8) agonist
| Study group | Role | What they receive |
|---|---|---|
| 0.5mg single-dose | Placebo comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. Receives: Drug: TQA3810 |
| 1.0mg single-dose | Placebo comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. Receives: Drug: TQA3810 |
| Food impact group | Other | Sixteen subjects were enrolled and all received the trial drug. Receives: Drug: TQA3810 |
| 0.1mg single-dose | Placebo comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. Receives: Drug: TQA3810 |
| 0.3mg single-dose | Placebo comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. Receives: Drug: TQA3810 |
| Drug interaction group | Active comparator | Sixteen subjects were enrolled and all received the trial drug. Receives: Drug: TQA3810 |
| 0.1mg multiple dosing | Placebo comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. Receives: Drug: TQA3810 |
| 0.3mg multiple dosing | Placebo comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. Receives: Drug: TQA3810 |
| 0.5mg multiple dosing | Placebo comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. Receives: Drug: TQA3810 |
| 0.2mg multiple dosing | Placebo comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. Receives: Drug: TQA3810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Occurrence of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded.
Measured: From the subject signed the informed consent form to 30 days after the last dose
Secondary outcomes (5)
Cmax
Maximum plasma drug concentration
Measured: 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
To maximum plasma drug concentration time.
Measured: 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)
Drug half-life in plasma.
Measured: 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
Plasma drug concentration from time 0 to the last measurable area under the drug concentration time curve.
Measured: 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-∞
Area under the plasma drug concentration time curve from time 0 to infinity.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Oct 2021
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 759 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
- NCT06431438
- Sponsor's protocol ID
- TQA3810-I-01
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 28 May 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 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of TQA3810 Tablets
- ClinicalTrials.gov ID
- NCT06431438
- Acronym / sponsor ID
- TQA3810-I-01
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 759 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 28 May 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 0.5mg single-dose | Placebo comparator | Drug: TQA3810Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
| 1.0mg single-dose | Placebo comparator | Drug: TQA3810Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
| Food impact group | Other | Drug: TQA3810Sixteen subjects were enrolled and all received the trial drug. |
| 0.1mg single-dose | Placebo comparator | Drug: TQA3810Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
| 0.3mg single-dose | Placebo comparator | Drug: TQA3810Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
| Drug interaction group | Active comparator | Drug: TQA3810Sixteen subjects were enrolled and all received the trial drug. |
| 0.1mg multiple dosing | Placebo comparator | Drug: TQA3810Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
| 0.3mg multiple dosing | Placebo comparator | Drug: TQA3810Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
| 0.5mg multiple dosing | Placebo comparator | Drug: TQA3810Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
| 0.2mg multiple dosing | Placebo comparator | Drug: TQA3810Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (25 listed)
- 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;
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 |
|---|---|---|
| TQA3810TQA3810 is a small-molecule Toll-like receptor (TLR8) agonist | Drug | 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 |
Primary outcome
Incidence of Adverse Events
Time frame: From the subject signed the informed consent form to 30 days after the last dose
Occurrence of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded.
5 secondary outcomes
Cmax
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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-∞
Time frame: 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
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 28 May 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 TQA3810 in people with Chronic Hepatitis B, 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 25 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 28 May 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?
Incidence of Adverse Events (time frame: From the subject signed the informed consent form to 30 days after the last dose). 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 28 May 2024.