NCT07867288RecruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HTX-001 in human adult participants.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 5 Oct 2026
- Start date
- 30 Oct 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Haya Therapeutics, Inc.
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07867288
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 30 Oct 2026 to the primary completion date, Mar 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History or current evidence of a clinically significant or uncontrolled underlying condition
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lahey Clinic Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| The Lindner Research Center at the Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Saint Luke's Health System Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.