Clincosm LogoSign in Get a demo

Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced Ejection Fraction (HFrEF)

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05328752
Collaborator
(none)
27
Enrollment
2
Locations
2
Arms
12.9
Anticipated Duration (Months)
13.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, randomized, sponsor open-label, participant and investigator blinded, placebo-controlled, single dose study to investigate the safety and tolerability of a single subcutaneous dose of XXB750 in HFrEF.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This is a multi-center, randomized, sponsor open-label, participant and investigator blinded, placebo-controlled, single dose study to investigate the safety and tolerability of a single subcutaneous dose of XXB750 in participants with HFrEF. A screening period of up to 28 days will be used to assess participants' eligibility. Participants will be randomized into one of two cohorts based on background therapy. Participants will be randomized in a 2:1 ratio (cohort 1) or 4:1 ratio (cohort 2) to receive a single dose of either subcutaneous (s.c.) XXB750 or placebo.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
randomized, placebo controlled single subcutaneous dose safety study of XXB750randomized, placebo controlled single subcutaneous dose safety study of XXB750
Masking:
Double (Participant, Care Provider)
Masking Description:
Site will have masked and unmasked investigators. An unmasked investigator will prepare and administer dose while a masked investigator will perform all assessments.
Primary Purpose:
Treatment
Official Title:
A Randomized, Participant and Investigator Blinded, Sponsor Open-label, Placebo-controlled, Single Dose Study to Investigate the Safety and Tolerability of XXB750 in Heart Failure Participants With Reduced Ejection Fraction (HFrEF)
Actual Study Start Date :
May 17, 2022
Anticipated Primary Completion Date :
Jun 13, 2023
Anticipated Study Completion Date :
Jun 13, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: XXB750

XXB750

Drug: XXB750
XXB750
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Number of participants experiencing Adverse Events, SAEs (if applicable) [91 days]

    To evaluate the safety and tolerability of a single subcutaneous dose of XXB750 in adult participants with chronic stable heart failure with reduced ejection fraction (HFrEF).

Secondary Outcome Measures

  1. Pharmacokineticsparameters Tmax [91 days]

    To evaluate the pharmacokinetics: Time to maximum concentation (Tmax) parameters of XXB750 in adult participants with chronic stable HFrEF.

  2. Pharmacokineticsparameters Cmax [91 days]

    To evaluate the pharmacokinetics parameters: Peak plasma concentration (Cmax) of XXB750 in adult participants with chronic stable HFrEF.

  3. Pharmacokineticsparameters AUClast [91 days]

    To evaluate the pharmacokinetics parameters: Area under the plasma concentration curve (AUClast) of XXB750 in adult participants with chronic stable HFrEF.

  4. Pharmacokinetics parameters AUCinf [91 days]

    To evaluate the pharmacokinetics parameters: Area under the curve (AUCinf) of XXB750 in adult participants with chronic stable HFrEF.

  5. Pharmacokineticsparameters Vd/F [91 days]

    To evaluate the pharmacokinetics parameters: Vd/F of XXB750 in adult participants with chronic stable HFrEF.

  6. Pharmacokineticsparameters CL/F [91 days]

    To evaluate the pharmacokinetics parameters: (CL/F) of XXB750 in adult participants with chronic stable HFrEF.

  7. Pharmacokineticsparameters T1/2 [91 days]

    To evaluate the pharmacokinetics parameters: (T1/2) of XXB750 in adult participants with chronic stable HFrEF.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 78 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:

  • NYHA functional class II-III

  • LVEF ≤ 45% documented at screening

  • Systolic blood pressure 110 - 180 mmHg (cohort 1) or 105-180 mmHg (cohort 2), and heart rate ≤90 beats per minute

  • Treatment with a stable dose of a beta blocker.

  • Cohort 1: Treatment with a stable dose of ACE inhibitor or ARB

  • Cohort 2: Treatment with a stable dose of sacubitril/valsartan.

Key Exclusion Criteria

  • Acute heart failure, acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid, or other major cardiovascular surgery, PCI, or carotid angioplasty within the 6 months prior to screening

  • Hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to LV dilatation at screening

  • Implantation of a CRT device within 3 months prior to screening or intent to implant a CRT during the study period

  • History of severe pulmonary disease (e.g. COPD) requiring chronic supplemental oxygen therapy or pulmonary hypertension requiring pharmacology treatment at Screening

  • eGFR <45 mL/min/1.73 m2 at screening

  • Cohort 1 only: Treatment with sacubitril/valsartan currently or within 2 weeks from screening

  • Cohort 2: Treatment with ACE inhibitor or ARB currently or within 4 weeks from screening

  • BMI >35 kg/m2

Other protocol-specific criteria may apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Jacksonville Florida United States 32216
2 Novartis Investigative Site Saint Paul Minnesota United States 55102

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05328752
Other Study ID Numbers:
  • CXXB750A12101
  • 2021-006683-24
First Posted:
Apr 14, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
heart failure
reduced ejection fraction
HFrEF
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jul 28, 2022