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A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects

Primary Purpose

Nonalcoholic Steatohepatitis (NASH)

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
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")
XZP-5610 Tablet for "Part C2"
Sponsored by
Xuanzhu Biopharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy adult males or females aged 18 to 60 years (inclusive).
  2. 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).
  3. 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
  4. No clinically significant vital signs, physical examination, laboratory tests, or ECG or chest radiograph findings.
  5. Subjects understand and comply with the study procedures, voluntarily participate, and sign an Informed Consent Form.

Exclusion Criteria:

  1. 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.
  2. 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:

    1. Confirmation of QTcF ≥ 450 ms by repeated measurements;
    2. Confirmation of QRS duration > 120 ms by repeated measurements;
    3. Confirmation of PR interval > 200 ms by repeated measurements;
    4. Findings that lead to difficulties in QTc measurement or difficult interpretation of QTc data;
    5. History of other risk factors for Torsades de Pointes tachycardia (e.g., heart failure, hypokalemia, family history of long QT syndrome);
    6. Presence of uncorrected hypokalemia or hypomagnesemia.

    Parts B and C:

    Any of the following was regarded as a criterion for exclusion:

    1. Family history of long QT syndrome (grandparents, parents and siblings);
    2. Resting QTcF ≥ 450 ms (males) or ≥ 460 ms (females) during the screening or baseline period.
  3. 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)
  4. 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)
  5. History of pancreatic injury or pancreatitis at screening, or significantly elevated blood amylase (> 1.5 x ULN)
  6. History of urinary tract obstruction or presence of urinary voiding difficulties at screening.
  7. History of cancer (malignancy) at the time of screening.
  8. Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or syphilis antibody
  9. History of significant drug abuse within 12 months prior to screening or positive urine drug screening
  10. 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).
  11. 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
  12. 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).
  13. Major surgery, or donation or loss of blood over 400 mL within 3 months prior to administration.
  14. Participation in other clinical trials and treatment with investigational productinvestigational product within 3 months prior to administration.
  15. 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).
  16. 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.
  17. Systolic blood pressure ≥ 140 mmHg or < 90 mmHg, and/or diastolic blood pressure ≥ 90 mmHg or < 50 mmHg at screening or prior to dosing
  18. Heart rate < 50 or > 100 beats/min at screening or prior to dosing.
  19. 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).
  20. 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.
  21. Fasting triglycerides > 200 mg/dL (2.27 mmol/L) at screening.
  22. 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.
  23. Those who could not tolerate blood sample collection.
  24. Subjects who are deemed by the investigator to be unsuitable for participation in the study.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Part A-experimental

Part A-placebo

Part B-experimental

Part B-placebo

Part C1-experimental

Part C2-experimental

Arm Description

Single Ascending Dose (SAD) phase

Single Ascending Dose (SAD) phase

multiple ascending dose (MAD) phase

multiple ascending dose (MAD) phase

Food Effect (FE) phase

Food Effect (FE) phase

Outcomes

Primary Outcome Measures

Cmax
Tmax
AUClast
AUCinf
T1/2
CL/F
Vz/F
Subject incidence of adverse events for XZP-5610 versus placebo

Secondary Outcome Measures

Full Information

First Posted
May 24, 2021
Last Updated
June 2, 2021
Sponsor
Xuanzhu Biopharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04913090
Brief Title
A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
March 4, 2022 (Anticipated)
Study Completion Date
March 4, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanzhu Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis (NASH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A-experimental
Arm Type
Experimental
Arm Description
Single Ascending Dose (SAD) phase
Arm Title
Part A-placebo
Arm Type
Placebo Comparator
Arm Description
Single Ascending Dose (SAD) phase
Arm Title
Part B-experimental
Arm Type
Experimental
Arm Description
multiple ascending dose (MAD) phase
Arm Title
Part B-placebo
Arm Type
Placebo Comparator
Arm Description
multiple ascending dose (MAD) phase
Arm Title
Part C1-experimental
Arm Type
Experimental
Arm Description
Food Effect (FE) phase
Arm Title
Part C2-experimental
Arm Type
Experimental
Arm Description
Food Effect (FE) phase
Intervention Type
Drug
Intervention Name(s)
XZP-5610 Tablet (for Part A)
Other Intervention Name(s)
5610
Intervention Description
Tablet(s) administered orally once daily for 1 Day
Intervention Type
Drug
Intervention Name(s)
Placebo to match XZP-5610 Tablet (for Part A)
Other Intervention Name(s)
5610 Placebo
Intervention Description
Tablet(s) administered orally once daily for 1 Day
Intervention Type
Drug
Intervention Name(s)
XZP-5610 Tablet (for Part B)
Other Intervention Name(s)
5610
Intervention Description
Tablet(s) administered orally once daily for 14 Days
Intervention Type
Drug
Intervention Name(s)
Placebo to match XZP-5610 Tablet (for Part B)
Other Intervention Name(s)
5610 Placebo
Intervention Description
Tablet(s) administered orally once daily for 14 Days
Intervention Type
Drug
Intervention Name(s)
XZP-5610 Tablet (for "Part C1")
Other Intervention Name(s)
5610
Intervention Description
Tablet(s) administered fasted orally once daily for 1 Day
Intervention Type
Drug
Intervention Name(s)
XZP-5610 Tablet for "Part C2"
Other Intervention Name(s)
5610
Intervention Description
Tablet(s) administered after a high-fat meal orally once daily for 1 Day
Primary Outcome Measure Information:
Title
Cmax
Time Frame
Single dose:Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17,Food Effect:Day1-Day4,Day8-Day11
Title
Tmax
Time Frame
Single dose:Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17,Food Effect:Day1-Day4,Day8-Day11
Title
AUClast
Time Frame
Single dose:Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17,Food Effect:Day1-Day4,Day8-Day11
Title
AUCinf
Time Frame
Single dose:Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17,Food Effect:Day1-Day4,Day8-Day11
Title
T1/2
Time Frame
Single dose:Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17,Food Effect:Day1-Day4,Day8-Day11
Title
CL/F
Time Frame
Single dose:Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17,Food Effect:Day1-Day4,Day8-Day11
Title
Vz/F
Time Frame
Single dose:Day1-Day4 , Multi dose: Day1,Day2,Day7,Day10,Day14-Day17,Food Effect:Day1-Day4,Day8-Day11
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Chen
Phone
+86-13910591245
Email
chenying@xuanzhubio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongyang Liu, Doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongyang Liu

12. IPD Sharing Statement

Plan to Share IPD
No

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A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects

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