This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on participants with POTS. The aim of the study is to see how safe, tolerable, and effective the study drug is. The study is looking at several other research questions, including: * How the study drug changes heart rate and blood pressure in participants with POTS * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * How the study drug affects symptoms associated with POTS
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
Subcutaneous (SC) administration
SC administration
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
North County Neurology Associates
Carlsbad, California, United States
Stanford University
Palo Alto, California, United States
Southern California Heart Specialists
Pasadena, California, United States
Yale University
New Haven, Connecticut, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Luke's MidAmerica Heart Institute
Kansas City, Missouri, United States
...and 6 more locations
Change in Heart Rate (HR) from supine to standing (DeltaHR)
Time frame: At Day 8
Change from baseline in DeltaHR-avg
Only for Cohort B
Time frame: At day 29
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through 90 Days
Severity of TEAEs
Time frame: Through 90 Days
DeltaHR
Time frame: At Day 15 and 29
Supine HR
Time frame: At Day 8, 15, and 29
Standing HR
Time frame: At Day 8, 15, and 29
Supine blood pressure (BP)
Time frame: At Day 8, 15, and 29
Standing BP
Time frame: At Day 8, 15, and 29
Concentrations of REGN7544 in serum
Time frame: Through 90 Days
Occurrence of anti-drug antibodies (ADAs) to REGN7544
Time frame: Through 90 Days
Magnitude of ADAs to REGN7544
Time frame: Through 90 Days
Change from baseline in Orthostatic Symptom Domain Scores of the Living with POTS Questionnaire (LWPQ)
Only for Cohort B
Time frame: At day 29
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