A Clinical Trial of XZP-6019 Tablets in Healthy Subjects

NCT05063968 | Unknown Phase 1

• 1 other identifier: 6019-CPK-1001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (8)

• Cmax

  Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.

• Tmax

  Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.

• AUC0-t

  Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.

• AUC0-inf

  Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.

• T1/2

  Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.

• CL/F

  Prior to dosing, 0.25,0.5,1,2,3,4,6,8,12,24,36,48,72 hours post dose.

• Vz/F

  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

  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.

Study Arms (6)

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

Interventions

XZP-6019 tablet DRUG

Tablet is administered orally once on Day 1 and Day 9, respectively

Part A - Single Ascending Dose (SAD) phase: Experimental

Placebo DRUG

Tablet is administered orally once on Day 1 and Day 9, respectively

Part A - Single Ascending Dose (SAD) phase:Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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 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

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 101125, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Ruihua Dong, Doctor

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingjing Wu

CONTACT

+86-010-57654511; wujingjing@xuanzhupharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 1, 2021
• Study Start: November 30, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)