Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369298
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-12
Brief Title:
Study of JK07 in Patients with Chronic Heart Failure
Sponsor:
Salubris Biotherapeutics Inc
Organization:
Salubris Biotherapeutics Inc
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults with Chronic Heart Failure RENEU-HF
Status:
RECRUITING
Status Verified Date:
2024-10
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:
RENEU-HF
Brief Summary:
This is a Phase 2 randomized double-blind placebo-controlled multiple dose study to assess the safety tolerability and efficacy of JK07 in participants aged 18-85 with heart failure
There will be 2 cohorts in this study
Cohort 1 Heart failure HF participants with left ventricular ejection fraction LVEF of 40
Cohort 2 Heart failure HF participants with left ventricular ejection fraction LVEF 40 and 65
Participants in both cohorts will be randomized into either low dose JK07 high dose JK07 or placebo Participants will have a 21 chance of receiving JK07 versus placebo
There will be 2 cohorts in this study
Cohort 1 Heart failure HF participants with left ventricular ejection fraction LVEF of 40
Cohort 2 Heart failure HF participants with left ventricular ejection fraction LVEF 40 and 65
Participants in both cohorts will be randomized into either low dose JK07 high dose JK07 or placebo Participants will have a 21 chance of receiving JK07 versus placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None