Primary Biliary CholangitisPhase 1NCT06888115
A Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
A Phase 1 study testing CS0159 in people with Primary Biliary Cholangitis, run by Cascade Pharmaceuticals, Inc at 3 sites in China.
Trial summary
Phase I Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- CS0159
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesChina
- Study dates
- 13 Mar 2025to 3 Jun 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and are able to complete the entire trial process according to the trial requirements.
- Subjects aged 18 to 75 years (inclusive) at the time of signing the informed consent form; male or female.
- At screening, the weight of male subjects is ≥50 kg, the weight of female subjects is ≥45 kg, and both are ≤100 kg; body mass index [BMI = weight (kg)/height2 (m2)] is within 18.0-32.0 kg/m2 (inclusive).
- Subjects and their partners agree to have no plans for conception or sperm/egg donation from the signing of the informed consent until 6 months after the last dosing of the study drug and voluntarily take effective contraception measures.
- For subjects with hepatic impairment, the following inclusion criteria must also be met:
- Group 1: subjects with mild hepatic impairment (Child-Pugh Class A, score 5-6), see Appendix 1 for specific scoring.
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- Group 2: subjects with moderate hepatic impairment (Child-Pugh Class B, score 7-9), see Appendix 1 for specific scoring.
- Subjects with hepatic impairment caused by prior primary liver disorders, who have not used albumin within 14 days prior to screening, and have been diagnosed with stable (≥1 month) hepatic impairment through past medical history, physical examination, laboratory tests, or imaging examinations.
- Subjects who have not taken any medications within 4 weeks prior to screening, or, for those requiring long-term treatment for hepatic impairment and/or other comorbid diseases, have been on stable medication for at least 4 weeks (stable medication is determined by the investigator, excluding medications prohibited by the protocol).
Who cannot join
- Subjects known to have a history of allergy to components or excipients of the investigational product, those with an allergic constitution (multiple drug and food allergies), or those with a history of allergic diseases (such as asthma, urticaria, eczema dermatitis, etc.).
- Subjects who have a malignant tumor, or a history of malignant tumor regardless of time from diagnosis.
- Subjects with severe infection, trauma, intestinal operation, or other major surgery within 4 weeks prior to screening.
- Subjects with a history of organic heart disease, cardiac failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, or long QT syndrome, or who have symptoms and family history of long QT syndrome (indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes).
- Subjects who have or previously had arrhythmia that requires clinical intervention and may affect survival during the trial; or those with clinically significant electrocardiogram abnormalities at screening [such as tachycardia/bradycardia requiring drug therapy, second- to third-degree atrioventricular block, or prolonged QTcF interval (male QTcF > 450 ms, female QTcF > 470 ms) (corrected using Fridericia's formula), or other clinically significant abnormalities determined by the clinician].
- Serum creatinine > upper limit of normal (ULN), or estimated glomerular filtration rate (eGFR) calculated using the modification of diet in renal disease (MDRD) formula ˂60 mL/min/1.73 m2.
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- Subjects who are scheduled for surgery or are likely to require hospitalization during the study period.
- Subjects with blood pressure ≥140/90 mmHg (allow retesting 2 times).
- Subjects with resting heart rate >100 bpm (allow retesting 2 times).
- Subjects positive for HIV antibody (HIV-Ab) testing.
- Within 4 weeks prior to drug dosing, subjects who have used herbal medicines or any drugs that may affect CYP3A enzyme activity (such as CYP3A inducers, i.e., barbiturates, carbamazepine, glucocorticoids, etc.; inhibitors, i.e., SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, etc.).
- Subjects who have taken any medications (including herbal medicines, vitamins, and health supplements) within 14 days before dosing (or 5 half-lives, whichever is longer), except for stable medications in subjects with hepatic impairment.
- Subjects who have participated in other clinical trials and received investigational products or medical devices within 1 month prior to screening, using the date of the last dosing in the clinical study as the time reference (if the clinical study drug has a long half-life, at least 5 half-lives must have elapsed between dosing in that study and dosing in this study).
- Subjects who have experienced blood loss or blood donation of ≥400 mL within 3 months prior to dosing, or plan to donate blood within 1 month after the end of this trial.
- Subjects who are addicted to smoking, or smoked more than 5 cigarettes per day within 3 months prior to screening, or unable to stop any tobacco product use during the study period.
- At present or within 1 month prior to screening, subjects with regular alcohol use, that is, women who consume more than 7 units of alcohol per week, men who consume more than 14 units of alcohol per week (1 unit = 14 g of pure alcohol); or subjects who test positive for alcohol breath at baseline; or who are unable to abstain from alcohol during the study.
- Subjects with drug abuse or use of soft drugs (e.g., marijuana) within 3 months prior to dosing, or use of hard drugs (e.g., cocaine, amphetamines, phencyclidine, etc.) within 1 year prior to dosing, or positive baseline urine drug abuse screening.
- Subjects who have consumed foods or beverages containing grapefruit juice/pomelo juice, or containing methylxanthine purines (tea, coffee, cola, chocolate, and energy drinks) within 48 h before dosing, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.
- Subjects who cannot tolerate venipuncture or have a fear of needles or blood.
- Subjects who have received a vaccine injection within 1 month prior to screening.
- Pregnant or breastfeeding women, or those with a positive blood pregnancy test.
- Subjects who, in the investigator's opinion, have poor compliance or other factors making them unsuitable for participation in this trial.
- Supplementary exclusion criteria for subjects with hepatic impairment (subjects meeting any one of the following criteria will be excluded):
- Subjects with positive syphilis tests.
- Subjects with a history of liver transplant.
- Subjects with drug-induced liver injury.
- Subjects with acute liver injury due to various causes.
- Subjects with cholestatic liver disease.
- Imaging indicates the presence of hepatocellular carcinoma (HCC) lesions and/or alpha-fetoprotein >20 ng/mL.
- At screening, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5× ULN.
- Subjects with hepatic failure and/or advanced hepatic decompensation as evidenced by:
- hepatic encephalopathy grade ≥3,
- ascites grade ≥2, and/or
- portal hypertension ≥10 mmHg.
- Apart from the primary liver disease itself, subjects with any history of serious diseases, or with a medical history or clinically significant abnormal laboratory test that the investigator believes may affect the study results, including but not limited to a history of diseases of the circulatory system, endocrine system, nervous system, digestive system, urinary system, or blood, immune, psychiatric, and metabolic diseases.
- Supplementary exclusion criteria for healthy subjects with normal hepatic function (subjects meeting any one of the following criteria will be excluded):
- Subjects positive for treponema pallidum (TP) antibody test.
- Subjects with previous primary diseases of major organs, including but not limited to neurological/psychiatric, cardiovascular, gastrointestinal, respiratory, urinary, endocrine, hematological, immune, and other diseases, whom the investigator determines are unsuitable to participate in this trial.
- Subjects with a history of hepatic dysfunction, or those whose results from various examinations during screening (including physical examination, vital signs, hematology, urinalysis, blood chemistry, coagulation function, thyroid function, 12-lead electrocardiogram, chest PA X-ray, abdominal ultrasound, etc.) are judged by the investigator to be abnormal and of clinical significance.
- Subjects with an age not within ±10 years of the mean age of subjects with moderate and mild hepatic impairment, and/or weight not within ±10% of the mean weight of subjects with moderate and mild hepatic impairment.
- Subjects with past or current hepatitis B and/or hepatitis C.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of CS0159 Tablets in Subjects With Mild (Child-Pugh: Class A), Moderate (Child-Pugh: Class B) Hepatic Impairment, and Normal Hepatic Function
Phase I Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
Read the detailed description
To evaluate the PK characteristics of CS0159 in subjects with mild hepatic impairment (Child-Pugh Class A), moderate hepatic impairment (Child-Pugh Class B), and sex, age, and body weight-matched healthy subjects with normal hepatic function, so as to provide a scientific basis for the appropriate dose and/or dosing interval adjustment in subjects with hepatic impairment.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- CS0159
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS0159Drug
Single oral dose of CS0159 4mg
| Study group | Role | What they receive |
|---|---|---|
| Guoup 1 | Experimental | Single oral dose of CS0159 in subjects with Child-Pugh Grade A Receives: Drug: CS0159 |
| Guoup 2 | Experimental | Single oral dose of CS0159 in subjects with Child-Pugh Grade B Receives: Drug: CS0159 |
| Guoup 3 | Experimental | Single oral dose of CS0159 in healthy subjects with normal liver function Receives: Drug: CS0159 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of CS0159 (Cmax)
Peak concentration
Measured: Day1 to day3
Pharmacokinetic parameters of CS0159 (AUC0-t)
Area under the concentration-time curve from time zero to the last measurable concentration
Measured: Day1 to day3
Pharmacokinetic parameters of CS0159 (AUC0-∞)
Area under the curve from time 0 extrapolated to infinite time
Measured: Day1 to day3
Pharmacokinetic parameters of CS0159 (Tmax)
Time to peak concentration
Measured: Day1 to day3
Pharmacokinetic parameters of CS0159 (t1/2)
Eliminate terminal half-life
Measured: Day1 to day3
Pharmacokinetic parameters of CS0159 (CL/F)
Apparent clearance
Measured: Day1 to day3
Pharmacokinetic parameters of CS0159 (MRT)
Mean Residence Time
Measured: Day1 to day3
Pharmacokinetic parameters of CS0159 (Vz/F)
(Vz/F)
Measured: Day1 to day3
Secondary outcomes (1)
Safety evaluation endpoints
Including the incidence and severity of AEs and SAEs.
Measured: Baseline to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start13 Mar 2025
- Primary completion29 May 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Cascade Pharmaceuticals, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhao wei feng, Master, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888115
- Sponsor's protocol ID
- CS0159-HI-CN-I-05
- Status last verified
- Jul 2025
- First submitted
- 5 Mar 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. 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 CS0159 Tablets in Subjects With Mild (Child-Pugh: Class A), Moderate (Child-Pugh: Class B) Hepatic Impairment, and Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT06888115
- Acronym / sponsor ID
- CS0159-HI-CN-I-05
- Conditions
- Primary Biliary Cholangitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cascade Pharmaceuticals, IncUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 21 Mar 2025 (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.
Phase I Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
Detailed description
To evaluate the PK characteristics of CS0159 in subjects with mild hepatic impairment (Child-Pugh Class A), moderate hepatic impairment (Child-Pugh Class B), and sex, age, and body weight-matched healthy subjects with normal hepatic function, so as to provide a scientific basis for the appropriate dose and/or dosing interval adjustment in subjects with hepatic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guoup 1 | Experimental | Drug: CS0159Single oral dose of CS0159 in subjects with Child-Pugh Grade A |
| Guoup 2 | Experimental | Drug: CS0159Single oral dose of CS0159 in subjects with Child-Pugh Grade B |
| Guoup 3 | Experimental | Drug: CS0159Single oral dose of CS0159 in healthy subjects with normal liver function |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and are able to complete the entire trial process according to the trial requirements.
- Subjects aged 18 to 75 years (inclusive) at the time of signing the informed consent form; male or female.
- At screening, the weight of male subjects is ≥50 kg, the weight of female subjects is ≥45 kg, and both are ≤100 kg; body mass index [BMI = weight (kg)/height2 (m2)] is within 18.0-32.0 kg/m2 (inclusive).
- Subjects and their partners agree to have no plans for conception or sperm/egg donation from the signing of the informed consent until 6 months after the last dosing of the study drug and voluntarily take effective contraception measures.
- Group 1: subjects with mild hepatic impairment (Child-Pugh Class A, score 5-6), see Appendix 1 for specific scoring.
Key exclusion criteria (41 listed)
- Subjects known to have a history of allergy to components or excipients of the investigational product, those with an allergic constitution (multiple drug and food allergies), or those with a history of allergic diseases (such as asthma, urticaria, eczema dermatitis, etc.).
- Subjects who have a malignant tumor, or a history of malignant tumor regardless of time from diagnosis.
- Subjects with severe infection, trauma, intestinal operation, or other major surgery within 4 weeks prior to screening.
- Subjects with a history of organic heart disease, cardiac failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, or long QT syndrome, or who have symptoms and family history of long QT syndrome (indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes).
- Subjects who have or previously had arrhythmia that requires clinical intervention and may affect survival during the trial; or those with clinically significant electrocardiogram abnormalities at screening [such as tachycardia/bradycardia requiring drug therapy, second- to third-degree atrioventricular block, or prolonged QTcF interval (male QTcF > 450 ms, female QTcF > 470 ms) (corrected using Fridericia's formula), or other clinically significant abnormalities determined by the clinician].
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 |
|---|---|---|
| CS0159Single oral dose of CS0159 4mg | Drug | Guoup 1, Guoup 2, Guoup 3 |
Primary outcome
Pharmacokinetic parameters of CS0159 (Cmax)
Time frame: Day1 to day3
Peak concentration
Pharmacokinetic parameters of CS0159 (AUC0-t)
Time frame: Day1 to day3
Area under the concentration-time curve from time zero to the last measurable concentration
Pharmacokinetic parameters of CS0159 (AUC0-∞)
Time frame: Day1 to day3
Area under the curve from time 0 extrapolated to infinite time
Pharmacokinetic parameters of CS0159 (Tmax)
Time frame: Day1 to day3
Time to peak concentration
Pharmacokinetic parameters of CS0159 (t1/2)
Time frame: Day1 to day3
Eliminate terminal half-life
Pharmacokinetic parameters of CS0159 (CL/F)
Time frame: Day1 to day3
Apparent clearance
Pharmacokinetic parameters of CS0159 (MRT)
Time frame: Day1 to day3
Mean Residence Time
Pharmacokinetic parameters of CS0159 (Vz/F)
Time frame: Day1 to day3
(Vz/F)
1 secondary outcome
Safety evaluation endpoints
Time frame: Baseline to Day 7
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 11 Jul 2025.
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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.
Zhao wei feng, Master principal investigator
The First Affiliated Hospital of Soochow University
3 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 CS0159 in people with Primary Biliary Cholangitis, run by Cascade Pharmaceuticals, Inc at 3 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 9 inclusion and 41 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Pharmacokinetic parameters of CS0159 (Cmax) (time frame: Day1 to day3). The study lists 8 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 11 Jul 2025.