A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atrial Fibrillation
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Allocation: Stage A: non-randomized; Stage B: randomized, double-blind and placebo-controlled Intervention Model: Two-stage study Masking: None; Stage A (open label); Stage B: randomized, double-blind and placebo-controlledMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
This is a two-stage study in patients with AF of recent onset: Stage A is open label and all patients will receive HBI-3000. In each of three dose cohorts, up to 10 patients will receive HBI-3000 by IV infusion (30 minutes). For each dosing cohort, sentinel dosing is planned. Each patient may enroll...
This is a two-stage study in patients with AF of recent onset: Stage A is open label and all patients will receive HBI-3000. In each of three dose cohorts, up to 10 patients will receive HBI-3000 by IV infusion (30 minutes). For each dosing cohort, sentinel dosing is planned. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment. In Stage A, three different dose levels are planned to be administered serially, lowest to highest, with assessment of safety, tolerability, and efficacy prior to proceeding to the next dose level group. The actual dose levels may be modified, and additional dose levels may be considered based on the observed results at each cohort. Stage B is the randomized, double-blind and placebo-controlled part of the study. Study drug for Stage B patients is either HBI-3000 or placebo. Two cohorts will be enrolled sequentially, lowest dose level first, with safety, efficacy, and available PK results evaluated by the Sponsor and iDMC prior to enrolling patients in the next/higher dose cohort. The dose level for the second cohort may be adjusted following interim review of results in the first cohort. Patients will be randomized to receive a single IV infusion of HBI 3000 or placebo over 30 minutes. In each of the dose cohorts, sequentially enrolled patients will be randomized at 2:1 ratio so that 40 patients will receive HBI 3000 infusion and 20 patients will receive placebo infusion. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment.
Tracking Information
- NCT #
- NCT04680026
- Collaborators
- Not Provided
- Investigators
- Not Provided
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