drugset
drugset / Trial / NCT02808585

Study to Assess the Safety, Tolerability and PK/PD After 4 Weekly SC Injections of PB1046 in Subjects With Stable HFrEF

NCT02808585 ↗

Phase 2 Completed 29 enrolled PhaseBio Pharmaceuticals Inc.
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2016-06
Primary completion
2017-12-06
Completion
2017-12-06

Drugs

EvaluationDrugModalityDoseRoute
Subject PB1046 Peptide 0.2 mg/kg Subcutaneous
Subject PB1046 Peptide 0.4 mg/kg Subcutaneous
Subject PB1046 Peptide 0.6 mg/kg Subcutaneous
Subject PB1046 Peptide 1.2 mg/kg Subcutaneous

Indications

heart failure