NCT04913090

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

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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nonalcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-31
• Primary completion: 2022-03-04
• Completion: 2022-03-04
• First posted: 2021-06-04
• Last updated: 2021-06-04

Locations

1 site across 1 country: China