REGN7544
DrugSubcutaneous (SC) administration
Other names: baloncibart
NCT Number: NCT06593600
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
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Notify Me18 year–55 year
All sexes
Interventional
Phase 2
University of Calgary, Calgary, Alberta, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria apply
Subcutaneous (SC) administration
Other names: baloncibart
SC administration
Time frame: At Day 8
Time frame: At day 29
Only for Cohort B
Time frame: Through 90 Days
Time frame: Through 90 Days
Time frame: At Day 15 and 29
Time frame: At Day 8, 15, and 29
Time frame: At Day 8, 15, and 29
Time frame: At Day 8, 15, and 29
Time frame: At Day 8, 15, and 29
Time frame: Through 90 Days
Time frame: Through 90 Days
Time frame: Through 90 Days
Time frame: At day 29
Only for Cohort B
Regeneron Pharmaceuticals
Industry
A Phase 2 Double-Blind Placebo-Controlled Single-Dose Study of Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of REGN7544, an NPR1 Antagonist Monoclonal Antibody, in Patients With Postural Orthostatic Tachycardia Syndrome
Acronym: PINNACLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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