Clinical Trials Logo

Clinical Trial Summary

The treatment of chronic bradycardia, one of the cardiovascular diseases, remains an essential unsolved issue. The objective of this project is to speed up a new drug CARDIX-101 clinical Phase 1IA trial for the treatment of chronic bradycardia and to solve an unmet medical need. To date, there is no regulatory approved drug of this type available in the U.S or the world. If the new drug CARDIX-101 demonstrated a significant positive effect on chronic bradycardia, it should have a sizeable demand and solve an unmet medical need.


Clinical Trial Description

Following FDA and ICH Good Clinical Practice (GCP) guidance, a clinical Phase I study titled "A Single Ascending Dose Clinical Study to Establish Safety and Tolerability of CARDIX-101 in Bradycardia Patients" was conducted at the University of California San Diego (UCSD) School of Medicine, Cardiac Electrophysiology Center, and Altman Clinical and Translational Research Institute and was completed in August 2020 under IND# 131775. The clinical Phase 1 study of CARDIX-101 was completed using eighteen patients with six ascending single-dose levels. There were no adverse effects observed or reported for all participating subjects related to the investigational medicine. A current clinical Phase IIA study, "An Exploratory Safety and Efficacy Study of CARDIX-101 for the treatment of Chronic Bradycardia," is a multi-center clinical study. The current clinical study is designed to utilize appropriate wearable monitoring devices for today's Decentralized Clinical Trial. This study will consist of a multi-site clinical exploratory study in chronic bradycardia patients. The study is open-label, and enrollment of a cohort occurs without randomization. The study investigates three dosage levels of CARDIX-101 (CARDIX-101A, CARDIX-101B, and CARDIX-101C). The initial cohort will be enrolled in a staggered manner. In this way, it will make the clinical study more accessible for the patient to participate. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05117346
Study type Interventional
Source Cardix Therapeutics LLC
Contact J. Jean WANG, PHD
Phone 7185818026
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date November 2021
Completion date September 2023

See also
  Status Clinical Trial Phase
Completed NCT03922386 - Safety and Electrical Performances of XFINE Leads N/A
Completed NCT03294018 - Heart Rate Changes Following the Administration of Sugammadex
Completed NCT02153242 - The Effects of Selective Site Right Ventricular Pacing
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT00950287 - Detection of Neonatal Bradycardia N/A
Completed NCT00721136 - Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation N/A
Completed NCT00286858 - Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Completed NCT00158925 - The EASYTRAK EPI Clinical Investigation Phase 3
Completed NCT00180557 - Austria Study - Analysis of Difference Between Active and Passive Fixation Leads Phase 4
Completed NCT01076348 - Model 4965 Post-Approval Study
Completed NCT04198220 - BIO|STREAM.ICM Obesity
Recruiting NCT04353960 - The Alaska Oculocardiac Reflex Study
Recruiting NCT04093414 - Left Bundle Area Versus Selective His Bundle Pacing N/A
Active, not recruiting NCT03786640 - Abbott Brady 3T MRI PMCF
Recruiting NCT04075084 - Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Recruiting NCT03008291 - His Bundle Pacing in Bradycardia and Heart Failure
Active, not recruiting NCT02641249 - Non-invasive Intervention for Apnea of Prematurity N/A
Completed NCT01688843 - Safety and Performance Study of the INGEVITY Lead N/A
Completed NCT00542854 - iPod and Other MP3 Players on ICDs and Pacemakers in Children N/A
Completed NCT00294034 - VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies N/A