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