Non-alcoholic Fatty Liver DiseasePhase 1NCT05063968
A Clinical Trial of XZP-6019 Tablets in Healthy Subjects
A Phase 1 study testing XZP-6019 tablet in people with Non-alcoholic Fatty Liver Disease, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - Food Effect (FE) phase, and Part C - multiple ascending dose (MAD) phase. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- XZP-6019 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2021to 30 Sep 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects meeting all of the following criteria will be enrolled in this study.
- Healthy adult males or females aged 18 to 45 years (including 18 and 45 years old).
- Body weight ≥ 50 kg for males and ≥ 45 kg for female; body mass index (BMI) in the range of 19.0-26.0 kg/m2 for the non-obese cohort and in the range of 28.1 -35.0 kg/m2 for the obese cohort (including the boundary value, BMI=weight/height2).
- No plans for childbearing or donating sperm/egg within the latest 6 months, and willing to use effective contraception within 6 months after the end of dosing
- No clinically significant findings in vital signs, physical examination, laboratory tests, or ECG or Lung CT for Low-dose.
- Subjects understand and comply with the study procedures, voluntarily participate, and sign an Informed Consent Form.
Who cannot join
- Subjects meeting any of the following criteria will not be enrolled in this study:
- With history or presence of clinically significant abnormalities, e.g.: significant abnormality or disease of endocrine, gastrointestinal, cardiovascular, hematologic, hepatic, immunologic, renal, respiratory, genitourinary or major neurological (including stroke and chronic epilepsy) or patients with psychosomatic disorders
- History of clinically significant ECG abnormalities or family history of long QT syndrome (grandparents, parents and siblings), or
- Any of the following was regarded as a criterion for exclusion:
- Confirmation of QTcF ≥ 450 ms by repeated measurements;
- Confirmation of QRS duration > 120 ms by repeated measurements;
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- Confirmation of PR interval > 200 ms by repeated measurements;
- Findings that make QTc measurement difficult or QTc data difficult to interpret;
- History of other risk factors for Torsades de Pointes tachycardia (e.g., heart failure, hypokalemia, family history of long QT syndrome);
- Presence of uncorrected hypokalemia or hypomagnesemia.
- Subjects with a known or suspected history of allergy to the test drug or its excipient components, or a history of clinically significant severe allergy (e.g., food, drug, latex allergy), or a history of atopic allergic disease (asthma, urticaria, eczematous dermatitis)
- History of dysphagia or any gastrointestinal disorder affecting drug absorption at screening, including history of frequent nausea or vomiting of any etiology, history of irregular gastrointestinal motility such as habitual diarrhea, constipation or pre-irritable bowel syndrome, or history of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastric division, or gastric banding)
- History of pancreatic injury or pancreatitis at screening, or significantly elevated blood amylase (> 1.5 ULN)
- History of urinary tract obstruction or presence of urinary voiding difficulties at screening.
- History of cancer (malignancy) at the time of screening.
- Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or syphilis antibody
- History of significant drug abuse within 12 months prior to screening or positive urinary drug test at screening
- Regular alcohol consumption within 3 months prior to screening, consuming more than 3 alcoholic drinks per day (one drink is approximately equal to: beer 354 mL/12 oz, wine 118 mL/4 oz, or distilled spirits 29.5 mL/1 oz), or evidence of alcohol abuse and excessive consumption as evidenced by alcohol breath test at screening (subjects consuming 4 alcoholic drinks per day may be enrolled at the discretion of the investigator).
- History of smoking within 3 months prior to screening, or a positive urinary nicotine test at screening, or who cannot give up smoking throughout the study period
- Excessive daily intake of coffee, tea, cola, energy drinks, or other caffeinated beverages within 3 months prior to screening, with excess defined as more than 6 servings (one serving is approximately equal to 120 mg of caffeine).
- Major surgery, or donation or loss of blood over 400 mL within 3 months prior to administration.
- Participation in other clinical trials and treatment with investigational product within 3 months prior to administration.
- Take any prescription, over-the-counter, health product, herbal or proprietary Chinese medicine within 4 weeks prior to administration (or less than 5 half-lives of the drug administration from the start of the trial).
- Women who are pregnant or breastfeeding, or of childbearing potential who are not using effective non-hormonal contraception (intrauterine device (IUD), barrier method with spermicide, or surgical sterilization, etc.) or are unwilling to continue using these methods during the trial until 6 months after discontinuation; men of childbearing potential who are unwilling to use physical methods of contraception during the trial until 6 months after discontinuation.
- At the time of screening, Systolic blood pressure ≥ 140 mmHg or < 90 mmHg, and/or diastolic blood pressure ≥ 90 mmHg or < 50 mmHg.
- At the time of screening, Heart rate < 50 or > 100 beats/min.
- Glomerular filtration rate (eGFR) < 90 ml/min/1.73m2 was estimated at screening according to the Chronic Kidney Disease Epidemic (CKD-EPI) formula (see Annex 1 for calculation formula).
- At screening, the liver function tests showed any measure of aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) or total bilirubin is > upper limit of normal (ULN) in non-obesity cohorts; liver function tests of obese group showed AST, ALT or ALP is > 1.5 ULN, or total bilirubin is > ULN in obesity cohort.
- Fasting triglycerides > 2.3mmol/L at the time of screening.
- Fasting glucose > 5.6 mmol/L in the non-obese cohort and > 6.1 mmol/L or glycosylated hemoglobin (HbA1c) ≥ 6.5% in the obese group at screening.
- Those who could not tolerate blood sample collection.
- Subjects who are deemed by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 101125
Ruihua Dong, Doctor, +86-13810461342, Ruihua_Dong_RW@163.com
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetics (PK) of XZP-6019 Tablets Following Single- and Multiple-ascending Doses (SAD/MAD) and Food Effects in Healthy Subjects
This study will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - Food Effect (FE) phase, and Part C - multiple ascending dose (MAD) phase.
Read the detailed description
Part A and Part C studies were designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trials to assess the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single and multiple oral doses of XZP-6019 tablets in healthy adult subjects. Part B is a single-center, randomized, open label, 2×2 crossover design to assess the food effects on PK of a single oral dose of XZP-6019 tablets in healthy adult subjects.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- XZP-6019 tablet, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XZP-6019 tabletDrug
Tablet is administered orally once on Day 1 and Day 9, respectively
PlaceboDrug
Tablet is administered orally once on Day 1 and Day 9, respectively
XZP-6019 tabletDrug
Tablet is administered fasted orally once on Day 1
XZP-6019 tabletDrug
Tablet is administered after a high-fat meal orally once on Day 9
XZP-6019 tabletDrug
Tablet is administered orally once daily for 14 Days continuously
PlaceboDrug
Tablet is administered orally once daily for 14 Days continuously
| Study group | Role | What they receive |
|---|---|---|
| Part A - Single Ascending Dose (SAD) phase: Experimental | Experimental | Not described Receives: Drug: XZP-6019 tablet |
| Part A - Single Ascending Dose (SAD) phase:Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part B - Food Effect (FE) phase: Experimental 1 | Experimental | Not described Receives: Drug: XZP-6019 tablet |
| Part B - Food Effect (FE) phase: Experimental 2 | Experimental | Not described Receives: Drug: XZP-6019 tablet |
| Part C - multiple ascending dose (MAD) phase: Experimental | Experimental | Not described Receives: Drug: XZP-6019 tablet |
| Part C - multiple ascending dose (MAD) phase:Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
Tmax
Measured: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
AUC0-t
Measured: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
AUC0-inf
Measured: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
T1/2
Measured: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
CL/F
Measured: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
Vz/F
Measured: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
Subject incidence of adverse events for XZP-6019 versus placebo
Measured: Part A: From signing Informed consent form to Day 16; Part B: From signing Informed consent form to Day 16; Part C: From signing Informed consent form to Day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start30 Nov 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanzhu Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Dong, Doctor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063968
- Sponsor's protocol ID
- 6019-CPK-1001
- Status last verified
- Aug 2021
- First submitted
- 21 Sep 2021
- Last updated
- 1 Oct 2021
- 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 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetics (PK) of XZP-6019 Tablets Following Single- and Multiple-ascending Doses (SAD/MAD) and Food Effects in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05063968
- Acronym / sponsor ID
- 6019-CPK-1001
- Conditions
- Non-alcoholic Fatty Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 1 Oct 2021 (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 will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - Food Effect (FE) phase, and Part C - multiple ascending dose (MAD) phase.
Detailed description
Part A and Part C studies were designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trials to assess the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single and multiple oral doses of XZP-6019 tablets in healthy adult subjects. Part B is a single-center, randomized, open label, 2×2 crossover design to assess the food effects on PK of a single oral dose of XZP-6019 tablets in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A - Single Ascending Dose (SAD) phase: Experimental | Experimental | Drug: XZP-6019 tablet |
| Part A - Single Ascending Dose (SAD) phase:Placebo | Placebo comparator | Drug: Placebo |
| Part B - Food Effect (FE) phase: Experimental 1 | Experimental | Drug: XZP-6019 tablet |
| Part B - Food Effect (FE) phase: Experimental 2 | Experimental | Drug: XZP-6019 tablet |
| Part C - multiple ascending dose (MAD) phase: Experimental | Experimental | Drug: XZP-6019 tablet |
| Part C - multiple ascending dose (MAD) phase:Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects meeting all of the following criteria will be enrolled in this study.
Key exclusion criteria (32 listed)
- Subjects meeting any of the following criteria will not be enrolled in this study:
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 |
|---|---|---|
| XZP-6019 tabletTablet is administered orally once on Day 1 and Day 9, respectively | Drug | Part A - Single Ascending Dose (SAD) phase: Experimental |
| PlaceboTablet is administered orally once on Day 1 and Day 9, respectively | Drug | Part A - Single Ascending Dose (SAD) phase:Placebo |
| XZP-6019 tabletTablet is administered fasted orally once on Day 1 | Drug | Part B - Food Effect (FE) phase: Experimental 1 |
| XZP-6019 tabletTablet is administered after a high-fat meal orally once on Day 9 | Drug | Part B - Food Effect (FE) phase: Experimental 2 |
| XZP-6019 tabletTablet is administered orally once daily for 14 Days continuously | Drug | Part C - multiple ascending dose (MAD) phase: Experimental |
| PlaceboTablet is administered orally once daily for 14 Days continuously | Drug | Part C - multiple ascending dose (MAD) phase:Placebo |
Primary outcome
Cmax
Time frame: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
Tmax
Time frame: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
AUC0-t
Time frame: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
AUC0-inf
Time frame: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
T1/2
Time frame: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
CL/F
Time frame: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
Vz/F
Time frame: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.
Subject incidence of adverse events for XZP-6019 versus placebo
Time frame: Part A: From signing Informed consent form to Day 16; Part B: From signing Informed consent form to Day 16; Part C: From signing Informed consent form to Day 42.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- 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.
Ruihua Dong, Doctor principal investigator
Beijing Friendship 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 XZP-6019 tablet in people with Non-alcoholic Fatty Liver Disease, run by Xuanzhu Biopharmaceutical 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 6 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 1 Oct 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingjing Wu (+86-010-57654511, wujingjing@xuanzhupharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.). 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 1 Oct 2021.