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Purpose

A Study of CTX340 in Participants with Uncontrolled Hypertension.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age: ≥18 and ≤75 years. 2. Body mass index ≤40 kg/m2. 3. 24-hour mean ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) measurement of ≥130 mm Hg but ≤160 mm Hg despite treatment 4. Be on treatment with ≥4 antihypertensive therapies at effective doses, of which ≥1 must be a diuretic. 5. Participants who at any point had childbearing potential must currently be postmenopausal 6. 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

  1. Serum aldosterone and direct renin concentration (or plasma renin activity [PRA]) suggestive of primary aldosteronism 2. Mean diastolic blood pressure (DBP) ≤65 mm Hg on screening ABPM. 3. Participants with vascular cause of hypertension which may be amendable to revascularization 4. Participants with treatable/reversible causes of uncontrolled hypertension 5. History of renal artery denervation within past 12 months. 6. Orthostatic hypotension 7. Complete blood count (CBC) outside the specified ranges per protocol. 8. Evidence of liver disease 9. History of a significant coagulation disorder. 10. Uncontrolled or untreated thyroid disease

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Phase 1: Sequential Single Ascending Dose Escalation Phase 2: Placebo Controlled Parallel Group
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Phase 1 is Open-Label, while Phase 2 is Double-Blind (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1: CTX340 		Phase 1 is An Open-Label, Ascending Dose Design.
  • Drug: CTX340
    CTX340 is an in vivo gene editing therapy designed to utilize clustered regularly interspaced short palindromic repeats-CRISPR-associated protein 9 (CRISPR-Cas9) to target and disrupt human angiotensinogen (AGT) gene in liver.
Experimental
Phase 2: Recommended Phase 2 Dose CTX340 		Phase 2: Recommended Phase 2 Dose CTX340.
  • Drug: CTX340
    CTX340 is an in vivo gene editing therapy designed to utilize clustered regularly interspaced short palindromic repeats-CRISPR-associated protein 9 (CRISPR-Cas9) to target and disrupt human angiotensinogen (AGT) gene in liver.
Experimental
Phase 2: Placebo 		Phase 2: Placebo.
  • Drug: Placebo
    One of the arms in Phase 2 will be placebo.

Recruiting Locations

Research Site 1
Port Orange, Florida 32127

More Details

Status
Recruiting
Sponsor
CRISPR Therapeutics AG

Study Contact

Clinical Trials
877-214-4634
medicalaffairs@crisprtx.com

Detailed Description

This is a dose ascending study of CTX340 in participants with hypertension. Subjects will receive CTX340 or placebo via intravenous (IV) infusion.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.