Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT05063968
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of XZP-6019 Tablets in Healthy Subjects
Sponsor:
Xuanzhu Biopharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: