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AB-1002 in Patients With Class III Heart Failure

NCT04179643 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-04-08

No results posted yet for this study

Summary

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of AB-1002 in patients with NYHA Class III heart failure. Patients with non-ischemic cardiomyopathy will be enrolled until up to 17 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).

Conditions

  • Congestive Heart Failure
  • Heart Failure
  • Heart Disease, Ischemic
  • Cardiovascular Diseases
  • Heart Failure, Systolic
  • Heart Failure，Congestive
  • Heart Arrhythmia
  • Heart Failure, Diastolic
  • Heart; Complications

Interventions

BIOLOGICAL

3 x 10e13vg AB-1002

There are 2 components to AB-1002. The first is an active I-1 transgene (AA 1-65 with T35D), and the second is the vector, BNP116, which delivers the gene selectively to the heart after intracoronary administration.

Sponsors & Collaborators

  • AskBio Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2024-08-20
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179643 on ClinicalTrials.gov