MyelofibrosisPhase 1NCT07480824
To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects
A Phase 1 study testing TQ05105 in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial summary
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the safety of the drug in these patients after a single dose. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- TQ05105
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the clinical trial and sign the informed consent form, with full understanding of the trial content, procedures, and potential adverse reactions.
- Patients (including partners) have no pregnancy plans or sperm/egg donation plans from screening until 6 months after the last dose of the investigational drug, and agree to use effective contraception.
- Aged 18-75 years (inclusive), regardless of gender.
- Male participants weigh ≥50.0 kg; female participants weigh ≥45.0 kg. Body mass index (BMI) = weight (kg)/height² (m²), with BMI ranging 18.0-32.0 kg/m² (inclusive).
- Patients can communicate effectively with investigators and comply with the trial protocol.
- Additional Criteria for Participants with Normal Liver Function:
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- Negative serum HBsAg and Hepatitis C Virus (HCV) antibody test results.
- Weight within ±10 kg of the average weight of groups A/B; age within ±10 years of the average age of groups A/B; gender distribution similar to groups A/B (±1 participant per gender).
- Additional Criteria for Participants with Impaired Liver Function:
- Chronic liver injury caused by primary liver diseases (e.g., hepatitis B/C, non-alcoholic fatty liver disease, alcoholic liver disease) or clinically diagnosed cirrhosis, classified as Child-Pugh Grade A or B.
- Stable condition within 2 weeks prior to dosing as judged by the investigator.
- No medication within 4 weeks before screening, or stable treatment regimen for underlying diseases (including liver-protective therapy).
Who cannot join
- History or current diagnosis of severe/chronic diseases (e.g., digestive, respiratory, neurological, cardiovascular, hematological, endocrine, oncological, immunological, or psychiatric disorders) deemed unsuitable by the investigator (except primary liver diseases and complications in participants with impaired liver function).
- Conditions affecting drug absorption, distribution, metabolism, or excretion (e.g., dysphagia) or prior gastrointestinal resection impacting these processes.
- Use of strong/moderate CYP3A4, CYP2C9, or CYP2C19 inducers/inhibitors within 4 weeks before screening.
- Known hypersensitivity to TQ05105 tablet components or allergic constitution (e.g., allergy to ≥2 substances, drug allergy history, or prone to rash/eczema/asthma).
- Average daily smoking >5 cigarettes within 3 months before screening.
- Drug abuse history or positive urine drug screen within 3 months.
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- For alcoholic liver disease participants: history of excessive drinking (>2 alcohol units/day) within 1 year; for others: such history within 3 months.
- Blood donation/loss ≥200 mL or plasmapheresis within 4 weeks before screening.
- Consumption of alcohol (or positive breath test), grapefruit juice, coffee, tea, cola, or chocolate within 48 hours before dosing.
- Creatinine clearance (CLcr) <60 mL/min.
- Pregnant/lactating women, positive pregnancy test, or unprotected sex within 2 weeks before screening.
- Positive HIV antibody or Treponema pallidum-specific antibody.
- Other factors deemed unsuitable by the investigator.
- Additional Exclusions for Normal Liver Function Participants:
- Use of prescription/non-prescription drugs, herbal medicines, or supplements (e.g., vitamins) within 2 weeks before screening.
- The results of physical examination during the screening period, vital signs, clinical laboratory tests (blood cell analysis (five categories), blood biochemistry, coagulation function, urine routine examination with sediment), electrocardiogram, frontal and lateral chest X-rays, abdominal ultrasound (liver, gallbladder, pancreas, spleen), and urinary system ultrasound, etc., which showed abnormal results and were determined by the research doctor to have clinical significance.
- Patients in other drug trials within 3 months or 5 half-lives (whichever longer) before screening.
- Additional Exclusions for Impaired Liver Function Participants:
- Had a history of liver transplantation;
- Patients with hepatic coma within 30 days before screening;
- Patients who had used drugs that might cause acute hepatotoxicity (such as halothane and methotrexate) within 3 months before screening;
- Patients with acute liver disease caused by drug or viral infection within 2 months before screening;
- With biliary cirrhosis, liver/bile duct obstruction, cholestatic liver disease and other diseases affecting biliary excretion;
- Patients with liver failure or liver cancer, or patients with a history of esophagogastric variceal bleeding, hepatic encephalopathy, severe portal hypertension, or a portasystemic shunt within 1 year before screening who were judged by the investigator to be ineligible for the trial;
- Patients with abnormal physical examination, vital signs, clinical laboratory tests (blood cell analysis (five classification), blood biochemistry, coagulation function, urine routine and sediment), AFP, electrocardiogram, chest X-ray, echocardiography, abdominal ultrasound (liver, gallbladder, pancreas and spleen), urinary ultrasound, and routine electroencephalogram (EEG) during the screening period and judged by the research doctors as not suitable for the study;
- Patients with massive ascites on ultrasound during the screening period who were assessed by the investigators as not suitable for the trial;
- Who participated in and used any investigational drug within 1 month before screening.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Jinan, Shandong, 250000
Wei Zhao, Doctor, 0531-85875449, zhao4wei2@hotmail.com
- Recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000
Caie Wang, Doctor, 13837915297, 245454618@qq.com
About this study
Official title: Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of TQ05105 in Participants With Mild Hepatic Impairment (Child-Pugh A), Moderate Hepatic Impairment (Child-Pugh B), and Healthy Subjects
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the safety of the drug in these patients after a single dose.
- Conditions
- Myelofibrosis
- Being tested
- TQ05105
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ05105Drug
Janus Kinase Inhibitors/Rho-associated Kinase (JAK/ROCK) inhibitors
| Study group | Role | What they receive |
|---|---|---|
| A: Mild hepatic impairment (Child-Pugh A) | Active comparator | A: 15 mg orally , single dose Receives: Drug: TQ05105 |
| B: Moderate hepatic impairment (Child-Pugh B) | Active comparator | B: 10 mg orally , single dose Receives: Drug: TQ05105 |
| C: Normal | Active comparator | C: 15 mg orally , single dose Receives: Drug: TQ05105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Maximum plasma drug concentration of TQ05105 and TQ12550
Measured: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Area under the concentration-time curve (AUC)
Area under the plasma concentration-time curve of TQ05105 and TQ12550
Measured: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Secondary outcomes (8)
Time-to-maximum concentration( Tmax) of TQ05105 and TQ12550
Time-to-maximum concentration
Measured: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Plasma half life (t1/2)
The time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half of TQ05105 and TQ12550
Measured: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48hours after administration
Apparent volume of distribution (Vz/F)
Apparent Volume of Distribution at the Terminal Phase divided by Bioavailability
Measured: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48hours after administration
Terminal elimination rate (λz)
First-order rate constant associated with the terminal (log-linear) elimination phase of TQ05105 and TQ12550
Measured: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Curve extrapolated to infinity (AUC_%Extrap)
Percentage of the Area Under the Curve extrapolated to infinity
Measured: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Apparent Clearance (CL/F)
The apparent volume of plasma from which the drug is completely removed per unit time, adjusted for bioavailability
Measured: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Fraction unbound(fu%)
The proportion of a drug or substance in the bloodstream that is not bound to plasma proteins and is therefore free to exert pharmacological activity, be metabolized, or undergo elimination.
Measured: 0.5, 2, 6 hours after administration
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
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
- NCT07480824
- Sponsor's protocol ID
- TQ05105-I-08
- Status last verified
- Feb 2026
- First submitted
- 14 Mar 2026
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of TQ05105 in Participants With Mild Hepatic Impairment (Child-Pugh A), Moderate Hepatic Impairment (Child-Pugh B), and Healthy Subjects
- ClinicalTrials.gov ID
- NCT07480824
- Acronym / sponsor ID
- TQ05105-I-08
- Conditions
- Myelofibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Mar 2026 (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 is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the safety of the drug in these patients after a single dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Mild hepatic impairment (Child-Pugh A) | Active comparator | Drug: TQ05105A: 15 mg orally , single dose |
| B: Moderate hepatic impairment (Child-Pugh B) | Active comparator | Drug: TQ05105B: 10 mg orally , single dose |
| C: Normal | Active comparator | Drug: TQ05105C: 15 mg orally , single dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily participate in the clinical trial and sign the informed consent form, with full understanding of the trial content, procedures, and potential adverse reactions.
- Patients (including partners) have no pregnancy plans or sperm/egg donation plans from screening until 6 months after the last dose of the investigational drug, and agree to use effective contraception.
- Aged 18-75 years (inclusive), regardless of gender.
- Male participants weigh ≥50.0 kg; female participants weigh ≥45.0 kg. Body mass index (BMI) = weight (kg)/height² (m²), with BMI ranging 18.0-32.0 kg/m² (inclusive).
- Patients can communicate effectively with investigators and comply with the trial protocol.
Key exclusion criteria (27 listed)
- History or current diagnosis of severe/chronic diseases (e.g., digestive, respiratory, neurological, cardiovascular, hematological, endocrine, oncological, immunological, or psychiatric disorders) deemed unsuitable by the investigator (except primary liver diseases and complications in participants with impaired liver function).
- Conditions affecting drug absorption, distribution, metabolism, or excretion (e.g., dysphagia) or prior gastrointestinal resection impacting these processes.
- Use of strong/moderate CYP3A4, CYP2C9, or CYP2C19 inducers/inhibitors within 4 weeks before screening.
- Known hypersensitivity to TQ05105 tablet components or allergic constitution (e.g., allergy to ≥2 substances, drug allergy history, or prone to rash/eczema/asthma).
- Average daily smoking >5 cigarettes within 3 months 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 |
|---|---|---|
| TQ05105Janus Kinase Inhibitors/Rho-associated Kinase (JAK/ROCK) inhibitors | Drug | A: Mild hepatic impairment (Child-Pugh A), B: Moderate hepatic impairment (Child-Pugh B), C: Normal |
Primary outcome
Peak concentration (Cmax)
Time frame: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Maximum plasma drug concentration of TQ05105 and TQ12550
Area under the concentration-time curve (AUC)
Time frame: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Area under the plasma concentration-time curve of TQ05105 and TQ12550
8 secondary outcomes
Time-to-maximum concentration( Tmax) of TQ05105 and TQ12550
Time frame: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration
Plasma half life (t1/2)
Time frame: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48hours after administration
Apparent volume of distribution (Vz/F)
Time frame: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48hours after administration
Terminal elimination rate (λz)
Time frame: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Curve extrapolated to infinity (AUC_%Extrap)
Time frame: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Apparent Clearance (CL/F)
Time frame: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24 hours after administration
Fraction unbound(fu%)
Time frame: 0.5, 2, 6 hours after administration
Adverse event rate
Time frame: Baseline up to day7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQ05105 in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites 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 12 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao, Doctor (0531-85875449, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration (Cmax) (time frame: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration). The study lists 2 primary outcomes in all. 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 6 Apr 2026.