Nonalcoholic Steatohepatitis (NASH)Phase 1NCT04913090
A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects
A Phase 1 study testing XZP-5610 Tablet (for Part A), XZP-5610 Tablet (for Part B) and XZP-5610 Tablet （for "Part C1"） in people with Nonalcoholic Steatohepatitis (NASH), 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 - multiple ascending dose (MAD) phase, and Part C - Food Effect (FE) phase. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH)
- What is being tested?
- XZP-5610 Tablet (for Part A), XZP-5610 Tablet (for Part B) and XZP-5610 Tablet （for "Part C1"）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2021to 4 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males or females aged 18 to 60 years (inclusive).
- Body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) in the range 19.0-28.0 kg/m2 for the non-obese group and in the range of 28.1 -35.0 kg/ 2 for the obese group (inclusive, BMI=weight/height2).
- No plans to have children within the last 6 months, no plans to donate sperm/egg, and willing to use effective contraception within 6 months after the end of dosing
- No clinically significant vital signs, physical examination, laboratory tests, or ECG or chest radiograph findings.
- Subjects understand and comply with the study procedures, voluntarily participate, and sign an Informed Consent Form.
Who cannot join
- History or presence of severe systemic diseases such as endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic epilepsy) abnormalities.
- History of clinically significant ECG abnormalities or family history of long QT syndrome (grandparents, parents and siblings)
- Part A:
- 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 lead to difficulties in QTc measurement or difficult interpretation of QTc data;
- 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.
- Parts B and C:
- Any of the following was regarded as a criterion for exclusion:
- Family history of long QT syndrome (grandparents, parents and siblings);
- Resting QTcF ≥ 450 ms (males) or ≥ 460 ms (females) during the screening or baseline period.
- Subjects with a known or suspected history of allergy to the test drug or its adjuvant 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 bowel pre-excitation 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 x 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 urine drug 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 ounces, wine 118 mL/4 ounces, or distilled spirits 29.5 mL/1 ounce), or evidence of alcohol abuse and excessive consumption as evidenced by alcohol breath test at screening (subjects who consume 4 alcoholic beverages per day may be enrolled at the investigator's (enrollment is at the discretion of the investigator).
- History of smoking within 3 months prior to screening, or a positive urine 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 servingis 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 productinvestigational product within 3 months prior to administration.
- Taken any prescription, over-the-counter, nutraceutical, herbal or proprietary Chinese medicine within 4 weeks prior to administration (or less than 5 half-lives of the drug 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.
- Systolic blood pressure ≥ 140 mmHg or < 90 mmHg, and/or diastolic blood pressure ≥ 90 mmHg or < 50 mmHg at screening or prior to dosing
- Heart rate < 50 or > 100 beats/min at screening or prior to dosing.
- The estimated glomerular filtration rate (eGFR) < 90 ml/min/ 1.73m2 at screening based on the Modification of Diet in Renal Disease Study (MDRD) formula (see Appendix 1 for calculation formula).
- At screening, the liver function tests of non-obese group showed any measure of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or total bilirubin> upper limit of normal (ULN); the liver function tests of obese group showed AST, ALT, or ALP> 1.5 × ULN, or total bilirubin> ULN.
- Fasting triglycerides > 200 mg/dL (2.27 mmol/L) at screening.
- Fasting glucose > 5.6 mmol/L in the non-obese group 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, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Dongyang Liu
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) of XZP-5610 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 - multiple ascending dose (MAD) phase, and Part C - Food Effect (FE) phase.
Read the detailed description
Part A and Part B 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-5610 tablets in healthy adult subjects, and exploring preliminary food effects (non-high-fat meals) in the Part B study. Part C is a single-center, randomized, open, 2×2 crossover design designed to assess the foodeffects on PK of a single oral dose of XZP-5610 tablets in healthy adult subjects.
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- XZP-5610 Tablet (for Part A), Placebo to match XZP-5610 Tablet (for Part A), XZP-5610 Tablet (for Part B), Placebo to match XZP-5610 Tablet (for Part B), XZP-5610 Tablet （for "Part C1"）
- 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-5610 Tablet (for Part A)Drug
Also called 5610
Tablet(s) administered orally once daily for 1 Day
Placebo to match XZP-5610 Tablet (for Part A)Drug
Also called 5610 Placebo
Tablet(s) administered orally once daily for 1 Day
XZP-5610 Tablet (for Part B)Drug
Also called 5610
Tablet(s) administered orally once daily for 14 Days
Placebo to match XZP-5610 Tablet (for Part B)Drug
Also called 5610 Placebo
Tablet(s) administered orally once daily for 14 Days
XZP-5610 Tablet （for "Part C1"）Drug
Also called 5610
Tablet(s) administered fasted orally once daily for 1 Day
XZP-5610 Tablet for "Part C2"Drug
Also called 5610
Tablet(s) administered after a high-fat meal orally once daily for 1 Day
| Study group | Role | What they receive |
|---|---|---|
| Part A-experimental | Experimental | Single Ascending Dose (SAD) phase Receives: Drug: XZP-5610 Tablet (for Part A) |
| Part A-placebo | Placebo comparator | Single Ascending Dose (SAD) phase Receives: Drug: Placebo to match XZP-5610 Tablet (for Part A) |
| Part B-experimental | Experimental | multiple ascending dose (MAD) phase Receives: Drug: XZP-5610 Tablet (for Part B) |
| Part B-placebo | Placebo comparator | multiple ascending dose (MAD) phase Receives: Drug: Placebo to match XZP-5610 Tablet (for Part B) |
| Part C1-experimental | Experimental | Food Effect (FE) phase Receives: Drug: XZP-5610 Tablet （for "Part C1"）; Drug: XZP-5610 Tablet for "Part C2" |
| Part C2-experimental | Experimental | Food Effect (FE) phase Receives: Drug: XZP-5610 Tablet （for "Part C1"）; Drug: XZP-5610 Tablet for "Part C2" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
Tmax
Measured: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
AUClast
Measured: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
AUCinf
Measured: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
T1/2
Measured: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
CL/F
Measured: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
Vz/F
Measured: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
Subject incidence of adverse events for XZP-5610 versus placebo
Measured: From drug administration to study completion. Single dose：15 days , Multi dose: 42 days，Food Effect: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start31 May 2021
- Primary completion4 Mar 2022 (estimated)
- Study completion4 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongyang Liu, Doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913090
- Sponsor's protocol ID
- 5610-1-001
- Status last verified
- Jun 2021
- First submitted
- 24 May 2021
- Last updated
- 4 Jun 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 4 Jun 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-5610 Tablets Following Single- and Multiple-ascending Doses (SAD/MAD) and Food Effects in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT04913090
- Acronym / sponsor ID
- 5610-1-001
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 4 Mar 2022 (estimated)
- Study completion
- 4 Mar 2022 (estimated)
- First posted
- 4 Jun 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 - multiple ascending dose (MAD) phase, and Part C - Food Effect (FE) phase.
Detailed description
Part A and Part B 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-5610 tablets in healthy adult subjects, and exploring preliminary food effects (non-high-fat meals) in the Part B study. Part C is a single-center, randomized, open, 2×2 crossover design designed to assess the foodeffects on PK of a single oral dose of XZP-5610 tablets in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A-experimental | Experimental | Drug: XZP-5610 Tablet (for Part A)Single Ascending Dose (SAD) phase |
| Part A-placebo | Placebo comparator | Drug: Placebo to match XZP-5610 Tablet (for Part A)Single Ascending Dose (SAD) phase |
| Part B-experimental | Experimental | Drug: XZP-5610 Tablet (for Part B)multiple ascending dose (MAD) phase |
| Part B-placebo | Placebo comparator | Drug: Placebo to match XZP-5610 Tablet (for Part B)multiple ascending dose (MAD) phase |
| Part C1-experimental | Experimental | Drug: XZP-5610 Tablet （for "Part C1"）, Drug: XZP-5610 Tablet for "Part C2"Food Effect (FE) phase |
| Part C2-experimental | Experimental | Drug: XZP-5610 Tablet （for "Part C1"）, Drug: XZP-5610 Tablet for "Part C2"Food Effect (FE) phase |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult males or females aged 18 to 60 years (inclusive).
- Body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) in the range 19.0-28.0 kg/m2 for the non-obese group and in the range of 28.1 -35.0 kg/ 2 for the obese group (inclusive, BMI=weight/height2).
- No plans to have children within the last 6 months, no plans to donate sperm/egg, and willing to use effective contraception within 6 months after the end of dosing
- No clinically significant vital signs, physical examination, laboratory tests, or ECG or chest radiograph findings.
- Subjects understand and comply with the study procedures, voluntarily participate, and sign an Informed Consent Form.
Key exclusion criteria (36 listed)
- History or presence of severe systemic diseases such as endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic epilepsy) abnormalities.
- History of clinically significant ECG abnormalities or family history of long QT syndrome (grandparents, parents and siblings)
- Subjects with a known or suspected history of allergy to the test drug or its adjuvant 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 bowel pre-excitation 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 x ULN)
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-5610 Tablet (for Part A)Also: 5610Tablet(s) administered orally once daily for 1 Day | Drug | Part A-experimental |
| Placebo to match XZP-5610 Tablet (for Part A)Also: 5610 PlaceboTablet(s) administered orally once daily for 1 Day | Drug | Part A-placebo |
| XZP-5610 Tablet (for Part B)Also: 5610Tablet(s) administered orally once daily for 14 Days | Drug | Part B-experimental |
| Placebo to match XZP-5610 Tablet (for Part B)Also: 5610 PlaceboTablet(s) administered orally once daily for 14 Days | Drug | Part B-placebo |
| XZP-5610 Tablet （for "Part C1"）Also: 5610Tablet(s) administered fasted orally once daily for 1 Day | Drug | Part C1-experimental, Part C2-experimental |
| XZP-5610 Tablet for "Part C2"Also: 5610Tablet(s) administered after a high-fat meal orally once daily for 1 Day | Drug | Part C1-experimental, Part C2-experimental |
Primary outcome
Cmax
Time frame: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
Tmax
Time frame: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
AUClast
Time frame: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
AUCinf
Time frame: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
T1/2
Time frame: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
CL/F
Time frame: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
Vz/F
Time frame: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11
Subject incidence of adverse events for XZP-5610 versus placebo
Time frame: From drug administration to study completion. Single dose：15 days , Multi dose: 42 days，Food Effect: 11 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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.
Dongyang Liu, Doctor principal investigator
Peking University Third 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-5610 Tablet (for Part A), XZP-5610 Tablet (for Part B) and XZP-5610 Tablet （for "Part C1"） in people with Nonalcoholic Steatohepatitis (NASH), 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 5 inclusion and 36 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 4 Jun 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 Ying Chen (+86-13910591245, chenying@xuanzhubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Single dose：Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17，Food Effect:Day1-Day4,Day8-Day11). 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 4 Jun 2021.