A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
Part of paid clinical trials in Bradenton, Florida.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07465653
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- HJB647 low dose — DRUGStudy drug low dose in capsule form
- HJB647 high dose — DRUGStudy drug high dose in capsule form
- Placebo — OTHERPlacebo control in capsule form
Study Details
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF).
Key Dates
- Start date
- Mar 18, 2026
- Status verified
- Apr 2026
- Primary completion
- Sep 24, 2026
- Completion
- Sep 24, 2026
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: PlaceboTaken by mouth as capsules
- Experimental: HJB647 low doseTaken by mouth as capsule
- Experimental: HJB647 high doseTaken by mouth as capsule
Primary Outcome Measure
Number of participants with Adverse Events (AEs) [ Time Frame: Up to 33 days ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Synergy Healthcare | Bradenton | Florida | 34208 | Shannon Stickels Patrick Weston (PRINCIPAL_INVESTIGATOR) |
| Nature Coast Clinical Research LLC | Inverness | Florida | 34452 | Rafik Abadier (PRINCIPAL_INVESTIGATOR) |
| Jacksonville Center for Clinical | Jacksonville | Florida | 32216 | Michael J Koren (PRINCIPAL_INVESTIGATOR) |
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