Primary Biliary CholangitisPhase 1NCT05624294
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects
A Phase 1 study testing CS0159 in people with Primary Biliary Cholangitis, run by Cascade Pharmaceuticals, Inc at 1 site in China.
Trial summary
This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 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?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2022to 28 Mar 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
- Healthy adult subjects of 18 years to 55 years.
- Weight: Male≥50kg, female≥45kg BMI: 18~32kg/m².
- In good health, determined by having no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluation.
- Subject signs IFC and dates and subject must understand and follow test procedures and restrictions.
Who cannot join
- Subjects with special dietary requirements and cannot follow a uniform diet.
- Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.
- Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2.
- History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Does/ Mulelple Ascending Does Study of CS0159 to Evaluate the Safety, Tolerability, Pharmacokynetics, and Food Effect in Healthy Subjects
This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy subjects.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- CS0159, Placebo
- 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
Tablets administered orally
PlaceboDrug
Tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| 2mg CS0159 | Experimental | One tablet daily for seven days. Receives: Drug: CS0159; Drug: Placebo |
| 4mg CS0159 | Experimental | Two tablet daily for seven days. Receives: Drug: CS0159; Drug: Placebo |
| 6mg CS0159 | Experimental | Three tablet daily for seven days. Receives: Drug: CS0159; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation, and AE of special interest, from baseline up to 15 days.
Measured: Upto day 15
Dose PK Parameter(C-max)
Evaluate the Peak Plasma Concentration.
Measured: day 1, day 7
Dose PK Parameter(AUC)
Evaluate the Area under the plasma concentration versus time curve.
Measured: day 1, day 7
Secondary outcomes (3)
Food effect PK Parameter(C-max)
Evaluate the Peak Plasma Concentration.
Measured: day 10
Food effect PK Parameter(AUC)
Evaluate the Area under the plasma concentration versus time curve.
Measured: day 10
QTc analysis
analysize the plasma Concentration relevance to QTcF
Measured: day 1, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start19 Dec 2022
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cascade Pharmaceuticals, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Liu, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624294
- Sponsor's protocol ID
- CS0159-001A
- Status last verified
- Apr 2023
- First submitted
- 14 Nov 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Does/ Mulelple Ascending Does Study of CS0159 to Evaluate the Safety, Tolerability, Pharmacokynetics, and Food Effect in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05624294
- Acronym / sponsor ID
- CS0159-001A
- Conditions
- Primary Biliary Cholangitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cascade Pharmaceuticals, IncUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 22 Nov 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 is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2mg CS0159 | Experimental | Drug: CS0159, Drug: PlaceboOne tablet daily for seven days. |
| 4mg CS0159 | Experimental | Drug: CS0159, Drug: PlaceboTwo tablet daily for seven days. |
| 6mg CS0159 | Experimental | Drug: CS0159, Drug: PlaceboThree tablet daily for seven days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult subjects of 18 years to 55 years.
- Weight: Male≥50kg, female≥45kg BMI: 18~32kg/m².
- In good health, determined by having no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluation.
- Subject signs IFC and dates and subject must understand and follow test procedures and restrictions.
Key exclusion criteria (4 listed)
- Subjects with special dietary requirements and cannot follow a uniform diet.
- Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.
- Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2.
- History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.
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 |
|---|---|---|
| CS0159Tablets administered orally | Drug | 2mg CS0159, 4mg CS0159, 6mg CS0159 |
| PlaceboTablets administered orally | Drug | 2mg CS0159, 4mg CS0159, 6mg CS0159 |
Primary outcome
Incidence and severity of adverse events [Safety and Tolerability]
Time frame: Upto day 15
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation, and AE of special interest, from baseline up to 15 days.
Dose PK Parameter(C-max)
Time frame: day 1, day 7
Evaluate the Peak Plasma Concentration.
Dose PK Parameter(AUC)
Time frame: day 1, day 7
Evaluate the Area under the plasma concentration versus time curve.
3 secondary outcomes
Food effect PK Parameter(C-max)
Time frame: day 10
Food effect PK Parameter(AUC)
Time frame: day 10
QTc analysis
Time frame: day 1, 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 3 May 2023.
- Individual participant dataSharing planned: No
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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.
Yun Liu principal investigator
Xuhui Central Hospital, Shanghai
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 CS0159 in people with Primary Biliary Cholangitis, run by Cascade Pharmaceuticals, Inc 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 4 inclusion and 4 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 3 May 2023. 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. 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 and severity of adverse events [Safety and Tolerability] (time frame: Upto day 15). The study lists 3 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 3 May 2023.