Overview
A Study of CTX340 in Participants with Uncontrolled Hypertension.
Description
This is a dose ascending study of CTX340 in participants with hypertension. Subjects will receive CTX340 or placebo via intravenous (IV) infusion.
Eligibility
Key Inclusion Criteria:
- Age: ≥18 and ≤75 years.
- Body mass index ≤40 kg/m2.
- 24-hour mean ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) measurement of ≥130 mm Hg but ≤160 mm Hg despite treatment
- Be on treatment with ≥4 antihypertensive therapies at effective doses, of which ≥1 must be a diuretic.
- Participants who at any point had childbearing potential must currently be postmenopausal
- All participants capable of producing sperm must agree to the use of an acceptable method of effective contraception and their partners with childbearing potential should also agree to use an effective method of contraception.
Exclusion Criteria:
- Serum aldosterone and direct renin concentration (or plasma renin activity \[PRA\]) suggestive of primary aldosteronism
- Mean diastolic blood pressure (DBP) ≤65 mm Hg on screening ABPM.
- Participants with vascular cause of hypertension which may be amendable to revascularization
- Participants with treatable/reversible causes of uncontrolled hypertension
- History of renal artery denervation within past 12 months.
- Orthostatic hypotension
- Complete blood count (CBC) outside the specified ranges per protocol.
- Evidence of liver disease
- History of a significant coagulation disorder.
- Uncontrolled or untreated thyroid disease
