Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548854
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase II Dose Exploration Clinical Trial Evaluating the Efficacy Safety and Pharmacokinetic Characteristics of STC314 Injection Administered Intravenously in Sepsis Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase II Dose Exploration Clinical Trial Evaluating the Efficacy Safety and Pharmacokinetic Characteristics of STC314 Injection Administered Intravenously in Sepsis Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Sepsis
Brief Summary:
One study evaluated the efficacy and safety of intravenous STC314 injection in patients with sepsis Sex and pharmacokinetic profiles of a multicenter randomized double-blind placebo-controlled II Phase I dose exploration clinical trial
Detailed Description:
This is a randomized double-blind placebo-controlled phase II dose exploration study The aim of this trial is to evaluate the efficacy safety and pharmacokinetic characteristics of STC314 injection in sepsis patients receiving loading dose and continuous intravenous infusion determine the optimal therapeutic dose and provide supporting evidence for phase III clinical trials The overall design of the experiment is shown in Figure 1 This experiment consists of three parallel groups including two treatment groups with different doses of STC314 injection and one placebo control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None