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A Clinical Trial of XZP-6019 Tablets in Healthy Subjects

NCT05063968 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-10-01

No results posted yet for this study

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

Interventions

DRUG

XZP-6019 tablet

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

DRUG

Placebo

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

DRUG

XZP-6019 tablet

Tablet is administered fasted orally once on Day 1

DRUG

XZP-6019 tablet

Tablet is administered after a high-fat meal orally once on Day 9

DRUG

XZP-6019 tablet

Tablet is administered orally once daily for 14 Days continuously

DRUG

Placebo

Tablet is administered orally once daily for 14 Days continuously

Sponsors & Collaborators

  • Xuanzhu Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ruihua Dong, Doctor · Beijing Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063968 on ClinicalTrials.gov