NCT05117346

An Exploratory Safety and Efficacy Clinical Study of CARDIX-101 for the Treatment of Chronic Bradycardia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cardix Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bradycardia

Interventions

Type	Name	Description
DRUG	CARDIX-101A, CARDIX-101B, CARDIX-101C	Each subject will receive, via oral administration, one capsule of study medicine per dose and three doses per day for 14±2-days treatment.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2021-11-11
• Last updated: 2024-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study