Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-31 @ 4:11 AM
Study NCT ID:
NCT07030504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety, Tolerability and Pharmacokinetic of SAL0133 Tablets in Chinese Adult Healthy Subjects
Sponsor:
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Organization:
Study Overview
Official Title:
The Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of SAL0133 Tablets in Chinese Adult Healthy Subjects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
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:
To evaluate the safety and tolerance of single and multiple administrations of SAL0133 tablets in adult healthy subjects in China receptivity.
Detailed Description:
This study was divided into two parts: Part A and Part B. Part A was single-center, randomized, double-blind, and placebo control, single-dose escalation study (SAD) was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after a single dose. Furthermore, food effect would be preliminarily evaluated the influence of the pharmacokinetic characteristics of SAL0133 tablets in Part A. Part B was a single-center, randomized, double-blind, placebo controlled, multiple-dose escalation study was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after multiple doses.
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?: