Hepatic Insufficiency (MeSH ID: D048550)Phase 1NCT07625618
A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function
A Phase 1 study testing MY008211A tablets in people with Hepatic Insufficiency (MeSH ID: D048550), run by Wuhan Createrna Science and Technology Co., Ltd at 1 site in China.
Trial summary
This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Insufficiency (MeSH ID: D048550)
- What is being tested?
- MY008211A tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 28 Dec 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the clinical study and sign the written ICF, be able to understand the procedures and methods of this study, and be able to complete the entire study process according to the study requirements;
- Age 18 to 70 years (inclusive) on the day of signing the ICF, male or female;
- Body weight: ≥ 50 kg for males, ≥ 45 kg for females; body mass index (BMI): 18.0-32.0 kg/m2 (both inclusive);
- Subjects (including their partners) have no birth plan from screening until 3 months after the administration of the investigational product and voluntarily take contraceptive measures, and have no plans to donate sperm or eggs;
- Glomerular filtration rate (calculated using the CKD-EPI formula) ≥ 60 mL/min;
Who cannot join
- Known or suspected history of immunodeficiency (e.g., history of frequent recurrent infections), hereditary or acquired complement deficiency;
- Clear history of capsular microbial infection within 6 months before screening, including but not limited to Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae and Legionella pneumophila.
- Subjects who have a previous history of tuberculosis infection or are currently suffering from tuberculosis infection;
- Active systemic bacterial, viral or fungal infections within 14 days before administration;
- Fever (≥ 38°C) within 7 days before administration;
- Subjects suspected of having a history of allergy to any component of the investigational product, or with allergic constitution (allergic to multiple drugs and foods, and judged by the investigator to be clinically significant);
- Those who have previously undergone surgery that, as judged by the investigator, will affect drug absorption, distribution, metabolism and excretion; or those who have undergone surgery within 4 weeks prior to screening; or those who plan to undergo surgery during the study;
- Those who cannot tolerate venipuncture or with a history of blood phobia and acupuncture syncope;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Jilin University
Jilin City, Changchun, 130000
About this study
This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.
Read the detailed description
This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.
It is planned to enroll 24 subjects, male or female. A total of 3 treatment groups will be set up: normal hepatic function group, mild hepatic impairment (Child-Pugh A) group, moderate hepatic impairment (Child-Pugh B) group, with 8 subjects in each group. Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
This study will first enroll subjects in Group A (mild hepatic impairment) and Group B (moderate hepatic impairment). Age, gender and body weight will not be matched between subjects in Groups A and B; after enrollment for Groups A and B is completed, subjects will be enrolled in Group C (normal hepatic function) as control subjects matched with the hepatic impairment subjects (Group A + Group B):
Subjects who sign the informed consent form (ICF) will be screened according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Clinical Research Unit (CRU) on Day -1 (D-1). On D1, they will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions and will be discharged after completing the observations and drop-out examinations on D4. They will receive a telephone follow-up on D11.
During the study, sample collection, recording of adverse events (AEs), concomitant medication/non-drug therapy, physical examination, vital signs, ECG, and clinical laboratory tests will be performed according to the protocol requirements.
- Conditions
- Hepatic Insufficiency (MeSH ID: D048550)
- Being tested
- MY008211A tablets
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY008211A tabletsDrug
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| normal hepatic function group | Experimental | Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions. Receives: Drug: MY008211A tablets |
| mild hepatic impairment (Child-Pugh A) group | Experimental | Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions. Receives: Drug: MY008211A tablets |
| moderate hepatic impairment (Child-Pugh B) group | Experimental | Not described Receives: Drug: MY008211A tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum concentration
Measured: up to 12 weeks
AUC0-last
area under the plasma concentration-time curve from 0 to the last quantifiable time point
Measured: up to 12 weeks
AUC0-inf
area under the plasma concentration-time curve from 0 to infinity
Measured: up to 12 weeks
Secondary outcomes (10)
Tmax
time to reach maximum concentration
Measured: up to 12 weeks
CL/F
apparent clearance
Measured: up to 12 weeks
Vz/F
apparent volume of distribution
Measured: up to 12 weeks
t1/2
terminal half-life
Measured: up to 12 weeks
body temperature
Measure the body temperature of the subjects, using degrees Celsius as the unit.
Measured: up to 12 weeks
IU/L or mIU/mL of HCG in the blood of reproductive-aged women
The blood human chorionic gonadotropin (HCG) pregnancy test will measure the concentration of HCG in the blood of reproductive-aged women to determine if they are pregnant. The units in the report will be presented in IU/L (international units per liter) and/or mIU/mL.
Measured: up to 12 weeks
12-lead ECG
Evaluate QT interval, PR interval, etc.
Measured: up to 12 weeks
adverse events and serious adverse events
Measured: up to 12 weeks
Pulse
Measure the pulse of the subjects, expressing it in units of beats per minute.
Measured: up to 12 weeks
Blood pressure
Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start20 Sep 2024
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Insufficiency (MeSH ID: D048550)Studies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Createrna Science and Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YaNan Wang, PHD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625618
- Sponsor's protocol ID
- MY008211-1-09
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The company's business decision
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic and Safety Study of MY008211A Tablets in Subjects With Impaired or Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT07625618
- Acronym / sponsor ID
- MY008211-1-09
- Conditions
- Hepatic Insufficiency (MeSH ID: D048550)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wuhan Createrna Science and Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 4 Jun 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 study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.
Detailed description
This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.
It is planned to enroll 24 subjects, male or female. A total of 3 treatment groups will be set up: normal hepatic function group, mild hepatic impairment (Child-Pugh A) group, moderate hepatic impairment (Child-Pugh B) group, with 8 subjects in each group. Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
This study will first enroll subjects in Group A (mild hepatic impairment) and Group B (moderate hepatic impairment). Age, gender and body weight will not be matched between subjects in Groups A and B; after enrollment for Groups A and B is completed, subjects will be enrolled in Group C (normal hepatic function) as control subjects matched with the hepatic impairment subjects (Group A + Group B):
Subjects who sign the informed consent form (ICF) will be screened according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Clinical Research Unit (CRU) on Day -1 (D-1). On D1, they will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions and will be discharged after completing the observations and drop-out examinations on D4. They will receive a telephone follow-up on D11.
During the study, sample collection, recording of adverse events (AEs), concomitant medication/non-drug therapy, physical examination, vital signs, ECG, and clinical laboratory tests will be performed according to the protocol requirements.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal hepatic function group | Experimental | Drug: MY008211A tabletsEach subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions. |
| mild hepatic impairment (Child-Pugh A) group | Experimental | Drug: MY008211A tabletsEach subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions. |
| moderate hepatic impairment (Child-Pugh B) group | Experimental | Drug: MY008211A tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily participate in the clinical study and sign the written ICF, be able to understand the procedures and methods of this study, and be able to complete the entire study process according to the study requirements;
- Age 18 to 70 years (inclusive) on the day of signing the ICF, male or female;
- Body weight: ≥ 50 kg for males, ≥ 45 kg for females; body mass index (BMI): 18.0-32.0 kg/m2 (both inclusive);
- Subjects (including their partners) have no birth plan from screening until 3 months after the administration of the investigational product and voluntarily take contraceptive measures, and have no plans to donate sperm or eggs;
- Glomerular filtration rate (calculated using the CKD-EPI formula) ≥ 60 mL/min;
Key exclusion criteria (8 listed)
- Known or suspected history of immunodeficiency (e.g., history of frequent recurrent infections), hereditary or acquired complement deficiency;
- Clear history of capsular microbial infection within 6 months before screening, including but not limited to Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae and Legionella pneumophila.
- Subjects who have a previous history of tuberculosis infection or are currently suffering from tuberculosis infection;
- Active systemic bacterial, viral or fungal infections within 14 days before administration;
- Fever (≥ 38°C) within 7 days before administration;
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 |
|---|---|---|
| MY008211A tabletsEach subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions. | Drug | mild hepatic impairment (Child-Pugh A) group, moderate hepatic impairment (Child-Pugh B) group, normal hepatic function group |
Primary outcome
Cmax
Time frame: up to 12 weeks
maximum concentration
AUC0-last
Time frame: up to 12 weeks
area under the plasma concentration-time curve from 0 to the last quantifiable time point
AUC0-inf
Time frame: up to 12 weeks
area under the plasma concentration-time curve from 0 to infinity
10 secondary outcomes
Tmax
Time frame: up to 12 weeks
CL/F
Time frame: up to 12 weeks
Vz/F
Time frame: up to 12 weeks
t1/2
Time frame: up to 12 weeks
body temperature
Time frame: up to 12 weeks
IU/L or mIU/mL of HCG in the blood of reproductive-aged women
Time frame: up to 12 weeks
12-lead ECG
Time frame: up to 12 weeks
adverse events and serious adverse events
Time frame: up to 12 weeks
Pulse
Time frame: up to 12 weeks
Blood pressure
Time frame: up to 12 weeks
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 4 Jun 2026.
- Individual participant dataSharing planned: No. The company's business decision
Related trials for Hepatic Insufficiency (MeSH ID: D048550)
Not yet recruitingPhase 1
Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment
Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B), Hepatic Insufficiency (MeSH ID: D048550)
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.
YaNan Wang, PHD principal investigator
The First Hospital of Jilin University
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 MY008211A tablets in people with Hepatic Insufficiency (MeSH ID: D048550), run by Wuhan Createrna Science and Technology 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 5 inclusion and 8 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 4 Jun 2026. 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?
Cmax (time frame: up to 12 weeks). 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 4 Jun 2026.