Clinical Trials
3
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
2
66.7%
Recruiting
1
33.3%
No approval data available
- Arch Biopartners has created Arch Clinical Pty Ltd in Australia to facilitate a Phase I safety trial for Metablok, a drug candidate targeting acute kidney injury. - The Phase I trial application has been submitted to the Alfred Health Human Research Ethics Committee, with a decision anticipated in early 2019. - The study will assess the safety and pharmacokinetics of Metablok (LSALT Peptide) in healthy participants through a double-blind, placebo-controlled design. - A successful Phase I trial will pave the way for a Phase II trial to evaluate Metablok's efficacy in preventing acute kidney injury in cardiac surgery patients.
- Arch Biopartners has commenced a Phase II clinical trial of LSALT peptide for preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI). - The trial is a multicenter, randomized, double-blind, placebo-controlled study aiming to enroll 240 patients undergoing on-pump cardiac surgery. - The primary objective is to assess the percentage of subjects developing acute kidney injury (AKI) within seven days post-surgery, based on KDIGO criteria. - CS-AKI is a common and serious complication, affecting up to 30% of patients undergoing CABG, and is linked to increased morbidity and mortality.
