New myelofibrosis drug tested in patients with liver issues
NCT ID NCT07480824
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study is testing a drug called TQ05105 in people with mild or moderate liver impairment and healthy volunteers. The goal is to see how the liver affects the drug's levels in the body and check for safety. 24 participants will receive a single dose and be monitored closely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TQ05105 (a JAK/ROCK inhibitor drug)
- What this could lead to
- If successful, this study could help determine safe dosing of TQ05105 for people with liver problems who have myelofibrosis.
- What could go wrong
- This is a very early Phase 1 trial with only 24 participants, so results may not apply broadly. The drug may still cause side effects or not work as expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: * 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). Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Henan University of Science & Technology
RECRUITINGLuoyang, Henan, 471000, China
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The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
NOT_YET_RECRUITINGJinan, Shandong, 250000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Half-Matched stem cells tested as cure for myelofibrosis
- Can blood tests predict transplant complications?
- Can a new daily pill shrink the spleen and ease myelofibrosis symptoms?
- Can a new pill tame myelofibrosis?
- MRI as a window into bone marrow disease: a new biomarker test?
- Can a menin inhibitor tame myelofibrosis when standard drugs fall short?