A Study of CTX340 in Participants with Uncontrolled Hypertension.
This is a dose ascending study of CTX340 in participants with hypertension. Subjects will receive CTX340 or placebo via intravenous (IV) infusion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Research Site 1
Port Orange, Florida, United States
RECRUITINGResearch Site 2
Melbourne, Australia
RECRUITINGPhase 1: Incidence of dose-limiting toxicities (DLTs)
To evaluate the safety and tolerability of a single ascending dose of CTX340 in participants with hypertension to determine the recommended Phase 2 dose (RP2D).
Time frame: Up to 12 months
Phase 2: Percentage change in circulating angiotensinogen (AGT) concentration from baseline
To evaluate the pharmacodynamics (PD) effect of CTX340 at the recommended Phase 2 dose (RP2D)
Time frame: Through 6 months of follow-up.
To assess the safety of CTX340
Incidence of adverse events (AEs), including treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs), clinically significant laboratory abnormalities, and clinically significant abnormal vital signs during 12 months of follow-up.
Time frame: From CTX340 infusion up to 12 months
To assess the effect of CTX340 on systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM)
Change from baseline in systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring (ABPM)
Time frame: From CTX340 infusion up to 12 months
To assess the pharmacodynamics (PD) effect of CTX340
Percentage change in circulating angiotensinogen (AGT) concentrations over time compared to baseline.
Time frame: Over 12 months, compared to baseline
To characterize the pharmacokinetics (PK) of CTX340
Plasma levels of LNP (ionizable lipid and PEG lipid)
Time frame: From CTX340 infusion up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.