Safety of HTX-001 in healthy adults and people with nonobstructive hypertrophic cardiomyopathy
Tests HTX-001 in healthy adults and adults with nonobstructive hypertrophic cardiomyopathy.
Plain-language title generated from the registry record
Registry title: Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001
Key facts
- Where
- Boston, Cincinnati, and Kansas City, United StatesSee the 3 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07867288, who can take part
Where in United States
- Lahey ClinicBoston, United StatesTaking people
- The Lindner Research Center at the Christ HospitalCincinnati, United StatesTaking people
- Saint Luke's Health SystemKansas City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haya Therapeutics, Inc.
- Trial code
- NCT07867288
- Record updated
- 4 November 2026
- Original description
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HTX-001 in human adult participants.Read full original descriptionShow less
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)
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HTX-001 in human adult participants.
Inclusion: 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: History or current evidence of a clinically significant or uncontrolled underlying condition; Any evidence of left ventricular outflow tract obstruction (LVOTO); Implantation of an implantable cardioverter-defibrillator (ICD) within 6 months; 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.