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RecruitingAccepts healthy volunteersPhase 1

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

Haya Therapeutics, Inc. · NCT07867288

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
10
US sites recruiting
2
Study start
October 2026
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: HTX-001

Conditions: Nonobstructive Hypertrophic Cardiomyopathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Lahey Clinic

    Boston, MA 01805

    Site contact: Amanda Kirshkaln-Leahy, MS, ACRP-PM · 781-825-8656 · Amanda.Kirshkaln-Leahy@lahey.org

  • Saint Luke's Health System

    Kansas City, MO 64111

    Site contact: Claire Clinical Research Nurse · 816-932-1627 · claire.pederson@bjc.org

All heart & blood pressure studies in Massachusetts →
Study to Assess the Safety, Tolerability, Pharmacokinetics, and… (NCT07867288) | Bored Studies