Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-04-05 @ 3:25 PM
Study NCT ID:
NCT06710561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-03
First Post:
2024-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Injectable SPN01 in Phase I.
Sponsor:
Beijing SonoPhotoNano Medical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
The Phase I Single-center, Single-blind, Randomized Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Injectable SPN01
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
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:
None
Brief Summary:
The primary objective of this study is: to evaluate the safety and tolerability of injectable SPN01 in subjects. The secondary objective of this study is: to evaluate the pharmacokinetic characteristics of injectable SPN01 in subjects.The exploratory objectives of this study are: (1)to evaluate the preliminary efficacy of injectable SPN01 in subjects with colorectal cancer. (2) to evaluate the effect of the blood concentration of injectable SPN01 on the QTc interval. (3) to evaluate the metabolic characteristics of injectable SPN01 in humans.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: