Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT06280534
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability Phase Ia Study of XT1061 in Single and Multiple Doses in Healthy Subjects
Sponsor:
Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Organization:
Study Overview
Official Title:
Randomized, Double-blind, Single Center Phase Ia Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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:
XT1061
Brief Summary:
A Randomized, Double-Blind, Single-Center Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects.
Detailed Description:
This trial is a randomized, double-blind, dose-escalation, placebo-controlled, single-center clinical study designed to evaluate the safety, tolerability, pharmacokinetic profile and metabolic conversion of XT1061 in healthy subjects with single and multiple administrations, as well as a study of the effect of food on pharmacokinetics.
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?: