Celltrion: CT-G20 in oHCM

Condition: Obstructive hypertrophic cardiomyopathy

Eligibility

Key Inclusion Criteria:

  • 18-70 years old
  • Established diagnosis of hypertrophic cardiomyopathy
  • Body mass index ≥18.0 to ≤36 kg/m2

Key Exclusion Criteria:

  • History of cardiac disease
  • History of clinically significant allergic reactions
  • Presence of gastrointestinal, renal, hepatic, hematological, metabolic, neurologic or pulmonary diseases
Study Name

A Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-G20 in Subjects With Hypertrophic Obstructive Cardiomyopathy (IRB no. 00000822)

Summary

This study focuses on adults (18-70 years old) who have been diagnosed with obstructive hypertrophic cardiomyopathy (oHCM). The purpose of the study is to determine the safety and tolerability of an investigational drug called CT-G20 in people with oHCM. The study will also determine how the drug is distributed within the body and its effects on the body. Obstructive hypertrophic cardiomyopathy is a condition in which heart muscle becomes abnormally thick, and blood flow out of the left ventricle is blocked.

Participants will be randomly assigned to receive either CT-G20 or placebo (inactive substance). CT G20 consists of an antiarrhythmic medication (medication used to treat irregular heartbeat) that improves the function of the left ventricle of the heart.

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