At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
PB1046 Injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled, Multiple-Dose, Study to Assess the Safety, Tolerability, PK and PD After 4 Weeks of Once Weekly Sc. Inj. of PB1046 in Adults With Stable HFrEF, and in Subjects With Cardiac Dysfunction Secondary to DMD
In Brief
A Phase 2 clinical trial evaluating PB1046 Injection and Placebo Injection for Heart Failure. Completed, enrolled 29 participants across 5 sites.
Detailed Summary
This study will be a sequential multiple-dose escalation study that will enroll (randomize and dose) approximately 28 subjects in four cohorts consisting of 3 active and 1 placebo in Cohort 1 and 6 active and 2 placebo in subsequent cohorts. Randomized subjects will receive a fixed weekly dose of study drug or placebo for a 4 week dosing period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJun 2016
First PostedJun 2016
Primary CompletionDec 2017
TodayJul 2026
First PostedJun 22, 2016
Enrollment StartJun 1, 2016
Primary CompletionDec 6, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.0 years ago
Interventions
PB1046 Injectiondrug
Four weekly subcutaneous injections of PB1046.
Placebo Injectiondrug
Four weekly subcutaneous injections of placebo.