Influenza, HumanPhase 1ZX-7101A-203NCT05711797
Pharmacokinetic Characteristics of Subjects with Hepatic Insufficiency and Healthy Subjects
A Phase 1 study testing ZX-7101A 80mg in people with Influenza, Human, run by Nanjing Zenshine Pharmaceuticals at 1 site in China.
Trial summary
The objective of this multicenter, open, single-dose, parallel controlled, Phase I clinical study is to Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver insufficiency compared with healthy subjects matched by age, weight, and sex. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- ZX-7101A 80mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2023to 9 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The presence of cirrhosis was confirmed by CT, magnetic resonance imaging (MRI), liver biopsy or noninvasive hepatic fibrosis test.
- The subject was determined to have liver insufficiency based on A Grade A or B on the Child-Pugh scale.
- If the subject has hepatic encephalopathy, the investigator determines that the current condition will not interfere with the subject's ability to provide appropriate informed consent.
Who cannot join
- Previous or present history of respiratory, blood, cardiovascular, digestive, urinary, endocrine and metabolic, neurological or psychiatric disorders with clinical manifestations.
- People with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- A history of gastrointestinal surgery or excision may interfere with oral drug absorption and/or excretion
- Patients with abnormal vital signs at screening visit and baseline visit: ear temperature > 37.5℃, pulse rate > 100 beats/min or < 50 beats/min, systolic blood pressure ≥140 mmHg or < 90 mmHg, diastolic blood pressure ≥90 mmHg or < 50mmHg.
- Participated in clinical studies of any drug or medical device within 3 months prior to screening, and participated in clinical studies of drug for 3 or more times within the last year.
- Severe infection, trauma, or major surgery within 4 weeks prior to screening, or clinically significant (as determined by the investigator) acute illness such as gastrointestinal disease, infection (e.g. respiratory or central nervous system infection, and idiopathic peritonitis) within 2 weeks prior to screening.
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- Had used any prescription drugs, Chinese herbs, or over-the-counter drugs (except birth control pills, acetaminophen, and topical over-the-counter preparations) in the 2 weeks prior to enrollment; Unless the principal investigator (PI) and the sponsor agree that the drug used has no impact on the safety and PK results of the study; If the combined drug has a longer half-life (more than 3 days), the required time interval will be longer and should be at least 5 half-lives of the drug.
- Smoking averaged more than 5 cigarettes per day in the 3 months prior to screening, or could not stop using any tobacco products during the study period.
- Persons who consumed more than 14 units of alcohol per week (1 unit = 360mL beer, 150 mL wine or 45 mL 40% spirits) in the 3 months prior to the screening period, or who had a positive alcohol breath test (screening period or baseline period), or who could not abstain during the study period.
- Test positive for hepatitis B (HBV) surface antigen, hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody or treponema pallidum antibody.
- Subjects with a history of substance abuse (e.g., morphine, dimethyldioxyamphetamine, methylamphetamine, tetrahydrocannabinol, ketamine, cocaine) or who screened positive for substance abuse.
- Those who received the vaccine within 30 days prior to administration or who planned to receive the vaccine during the study period.
- Donors who donated > 400 mL within 3 months prior to the screening period or > 200 mL within 4 weeks or planned to donate blood during the study period.
- Patients with difficulty in venous blood collection.
- Vigorous exercise should not be prohibited within 48 hours before and during the study period.
- It is expected that patients may be scheduled for surgery or hospitalization during the study.
- Any other circumstances which, in the opinion of the investigator, may affect the subject's ability to provide informed consent or to follow the protocol of the study, to complete the study in accordance with the study procedure, or the subject's participation in the study may affect the results of the study or his or her own safety.
Trial locations and contacts
1 site in 1 country.
China1 site
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai
About this study
Official title: An Open, Parallel Study Evaluating the Pharmacokinetic Profile, Safety, and Tolerability of a Single Oral Dose of ZX-7101A Tablets in Subjects with Mild or Moderate Liver Insufficiency and Healthy Subjects
The objective of this multicenter, open, single-dose, parallel controlled, Phase I clinical study is to Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver insufficiency compared with healthy subjects matched by age, weight, and sex. And to evaluate the the safety and tolerability of ZX-7101A by a single oral dose in subjects.
The main questions it aims to answer are:
- Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver dysfunction and healthy subjects with normal liver function matched for age, weight, and sex.
- To evaluate the safety and tolerability of ZX-7101A by a single oral dose in subjects.
- Conditions
- Influenza, Human
- Being tested
- ZX-7101A 80mg
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZX-7101A 80mgDrug
ZX-7101A a drug to treatment influenza in Chinese adults
| Study group | Role | What they receive |
|---|---|---|
| ZX-7101A 80mg Mild or moderate liver insufficiency | Experimental | Not described Receives: Drug: ZX-7101A 80mg |
| ZX-7101A 80mg Normal liver function | Experimental | Not described Receives: Drug: ZX-7101A 80mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
To evaluate the peak concentration of ZX-7101A after a single oral administration in subjects with mild and moderate hepatic insufficiency
Measured: From dosing to 15 days after medication
AUC
To evaluate the area under curve of ZX-7101A after a single oral administration in subjects with mild and moderate hepatic insufficiency
Measured: From dosing to 15 days after medication
Secondary outcomes (1)
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 after a single oral administration ZX-7101A
The Number of Participants with Treatment-Related Adverse Events will be evaluated as the change of vital signs, electrocardiogram (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline.
Measured: From dosing to 29 days after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start12 Apr 2023
- Primary completion6 Feb 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- Model description
- 80mg ZX-7101A
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Zenshine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xian yu huang, doctor, Study director, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711797
- Sponsor's protocol ID
- ZX-7101A-203
- Acronym
- ZX-7101A-203
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2023
- Last updated
- 5 Nov 2024
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Parallel Study Evaluating the Pharmacokinetic Profile, Safety, and Tolerability of a Single Oral Dose of ZX-7101A Tablets in Subjects with Mild or Moderate Liver Insufficiency and Healthy Subjects
- ClinicalTrials.gov ID
- NCT05711797
- Acronym / sponsor ID
- ZX-7101A-203 / ZX-7101A-203
- Conditions
- Influenza, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nanjing Zenshine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 3 Feb 2023 (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.
The objective of this multicenter, open, single-dose, parallel controlled, Phase I clinical study is to Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver insufficiency compared with healthy subjects matched by age, weight, and sex. And to evaluate the the safety and tolerability of ZX-7101A by a single oral dose in subjects.
The main questions it aims to answer are:
- Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver dysfunction and healthy subjects with normal liver function matched for age, weight, and sex.
- To evaluate the safety and tolerability of ZX-7101A by a single oral dose in subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 80mg ZX-7101A
| Arm | Type | Receives |
|---|---|---|
| ZX-7101A 80mg Mild or moderate liver insufficiency | Experimental | Drug: ZX-7101A 80mg |
| ZX-7101A 80mg Normal liver function | Experimental | Drug: ZX-7101A 80mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The presence of cirrhosis was confirmed by CT, magnetic resonance imaging (MRI), liver biopsy or noninvasive hepatic fibrosis test.
- The subject was determined to have liver insufficiency based on A Grade A or B on the Child-Pugh scale.
- If the subject has hepatic encephalopathy, the investigator determines that the current condition will not interfere with the subject's ability to provide appropriate informed consent.
Key exclusion criteria (17 listed)
- Previous or present history of respiratory, blood, cardiovascular, digestive, urinary, endocrine and metabolic, neurological or psychiatric disorders with clinical manifestations.
- People with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- A history of gastrointestinal surgery or excision may interfere with oral drug absorption and/or excretion
- Patients with abnormal vital signs at screening visit and baseline visit: ear temperature > 37.5℃, pulse rate > 100 beats/min or < 50 beats/min, systolic blood pressure ≥140 mmHg or < 90 mmHg, diastolic blood pressure ≥90 mmHg or < 50mmHg.
- Participated in clinical studies of any drug or medical device within 3 months prior to screening, and participated in clinical studies of drug for 3 or more times within the last year.
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 |
|---|---|---|
| ZX-7101A 80mgZX-7101A a drug to treatment influenza in Chinese adults | Drug | ZX-7101A 80mg Mild or moderate liver insufficiency, ZX-7101A 80mg Normal liver function |
Primary outcome
Cmax
Time frame: From dosing to 15 days after medication
To evaluate the peak concentration of ZX-7101A after a single oral administration in subjects with mild and moderate hepatic insufficiency
AUC
Time frame: From dosing to 15 days after medication
To evaluate the area under curve of ZX-7101A after a single oral administration in subjects with mild and moderate hepatic insufficiency
1 secondary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 after a single oral administration ZX-7101A
Time frame: From dosing to 29 days after medication
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 5 Nov 2024.
- 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.
Xian yu huang, doctor study director
Huashan Hospital
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 ZX-7101A 80mg in people with Influenza, Human, run by Nanjing Zenshine Pharmaceuticals 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 3 inclusion and 17 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 5 Nov 2024. 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: From dosing to 15 days after medication). 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 5 Nov 2024.