NCT05063968

A Clinical Trial of XZP-6019 Tablets in Healthy Subjects

A Phase I Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetics (PK) of XZP-6019 Tablets Following Single- and Multiple-ascending Doses (SAD/MAD) and Food Effects in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Part A and Part C 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-6019 tablets in healthy adult subjects. Part B is a single-center, randomized, open label, 2×2 crossover design to assess the food effects on PK of a single oral dose of XZP-6019 tablets in healthy adult subjects.

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2021-10-01
• Last updated: 2021-10-01

Locations

1 site across 1 country: China