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.

Xuanzhu Biopharmaceutical Co., Ltd.1 site in 1 country112 target enrollmentMay 31, 2021

ConditionsNonalcoholic Steatohepatitis (NASH)

InterventionsXZP-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"

DrugsXZP-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"

Overview

Phase: Phase 1
Intervention: XZP-5610 Tablet (for Part A)
Conditions: Nonalcoholic Steatohepatitis (NASH)
Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.
Enrollment: 112
Locations: 1
Primary Endpoint: AUClast
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 31, 2021

End Date

March 4, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xuanzhu Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

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)
•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: