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Recruiting NCT07867288

Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001

Conditions: Nonobstructive Hypertrophic Cardiomyopathy

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 10
Sponsor: Haya Therapeutics, Inc.

Location: Lahey Clinic Boston Massachusetts

Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HTX-001 in human adult participants.

Eligibility Criteria

Inclusion Criteria: * Diagnosis of nHCM * On a stable regimen of guideline-directed medical therapy for nHCM * NYHA functional class II or III * NT-proBNP \>300 pg/mL * Body weight of 50 to 100 kg, inclusive, and BMI ≤40 kg/m2, inclusive * Adequate renal function * Not pregnant, and willing to use acceptable birth control methods * Able and willing to comply with study procedures Exclusion Criteria: * Any evidence of left ventricular outflow tract obstruction (LVOTO) * Implantation of an implantable cardioverter-defibrillator (ICD) within 6 months * History or current evidence of a clinically significant or uncontrolled underlying condition * Unable to tolerate subcutaneous dosing * Any reason that in the opinion of the Investigator would lead to the inability of the participant to comply with the protocol

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07867288). StuddyBuddy aggregates publicly available trial information.