Ischemia-reperfusion Injury Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BX-001N After Intravenous Administration in Healthy Participants
This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BX-001N after intravenous administration in approximately 64 healthy participants
This study comprises of 2 parts: - Part 1- Single Ascending Dose (SAD)- This part will enroll approximately 40 participants across 5 cohorts where each participant will receive a single intravenous (IV) bolus dose in healthy participants. On Day 1, participants in each cohort will receive investigational product (IP) (i.e., BX-001N or Placebo) as a single IV bolus following a minimum 8-hour fast. - Part 2 -Multiple Ascending Dose (MAD)- This part will enroll approximately 24 participants across 3 cohorts where each participants will receive intravenous (IV) bolus dose for 7 sequential daily. At the same time each morning from Day 1 to Day 7 (inclusive), participants in each cohort will receive IP (i.e., BX-001N or Placebo) as a single IV bolus following a minimum 8-hour fast. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05327348 -
Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery
|
Phase 3 | |
| Completed |
NCT00184912 -
The Effect of Caffeine on Ischemic Preconditioning
|
N/A | |
| Recruiting |
NCT05585255 -
Clinical Significance of DKK2 Protein in Cerebral Ischemia-reperfusion Injury
|
||
| Completed |
NCT05598177 -
Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion Injury in Patients Undergoing Open Heart Surgery With Cardiopulmonary Bypass
|
Phase 4 | |
| Completed |
NCT04284592 -
Remote Ischemic Postconditioning Increases HIF-1α Plasma Levels and Improves Cardiac Markers After Cardiac Surgery
|
N/A | |
| Withdrawn |
NCT00441714 -
Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
|
N/A | |
| Completed |
NCT00248040 -
Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation
|
Phase 2 | |
| Completed |
NCT01486212 -
Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers
|
N/A | |
| Completed |
NCT01073202 -
Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation
|
N/A | |
| Completed |
NCT00224406 -
Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
|
Phase 2 | |
| Active, not recruiting |
NCT05246618 -
FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation
|
Phase 1/Phase 2 | |
| Completed |
NCT02118753 -
The Effect of EPLerenone on Ischemia Reperfusion Injury in Human myoCARDium
|
N/A | |
| Completed |
NCT01739088 -
Pediatric Remote Ischemic Pre-conditioning Prior to Complex Cardiac Surgery
|
N/A | |
| Completed |
NCT01040013 -
Gut Oxygenation and Laparoscopy
|
Phase 2 | |
| Suspended |
NCT00184847 -
Adenosine Receptors Influence Ischemia-Reperfusion Injury
|
N/A | |
| Completed |
NCT01172171 -
The Effect of Melatonin on Ischemia-reperfusion Injury Following Acute Myocardial Infarction
|
Phase 2 | |
| Completed |
NCT00457405 -
Does a Seven Day Treatment With Dipyridamole Induce Protection Against Ischemia-Reperfusion Injury?
|
Phase 4 | |
| Completed |
NCT00184821 -
Ischemic Injury and Ischemic Preconditioning in Diabetes
|
N/A | |
| Not yet recruiting |
NCT00691613 -
Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model
|
N/A | |
| Completed |
NCT03818126 -
The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement
|
N/A |