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

NCT04913090 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2021-06-04

No results posted yet for this study

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.

Conditions

  • Nonalcoholic Steatohepatitis (NASH)

Interventions

DRUG

XZP-5610 Tablet (for Part A)

Tablet(s) administered orally once daily for 1 Day

DRUG

Placebo to match XZP-5610 Tablet (for Part A)

Tablet(s) administered orally once daily for 1 Day

DRUG

XZP-5610 Tablet (for Part B)

Tablet(s) administered orally once daily for 14 Days

DRUG

Placebo to match XZP-5610 Tablet (for Part B)

Tablet(s) administered orally once daily for 14 Days

DRUG

XZP-5610 Tablet （for "Part C1"）

Tablet(s) administered fasted orally once daily for 1 Day

DRUG

XZP-5610 Tablet for "Part C2"

Tablet(s) administered after a high-fat meal orally once daily for 1 Day

Sponsors & Collaborators

  • Xuanzhu Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dongyang Liu, Doctor · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2022-03-04
Completion
2022-03-04

Countries

  • China

Study Locations

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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 NCT04913090 on ClinicalTrials.gov