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

A Two-Part, Phase 1, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and WISPER Target Engagement of HTX-001 in Adult Healthy Participants (Part 1) and in Adult Participants With Nonobstructive Hypertrophic Cardiomyopathy (Part 2)

Who can join

Ages 18 to 70 · All sexes · Healthy volunteers welcome

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

About the study

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

What is being tested

• HTX-001 (drug)

Sponsor: Haya Therapeutics, Inc. · Participants: 10 · Started: Oct 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07867288

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.