drugset / Trial / NCT04285827

Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease

NCT04285827 ↗

Phase 1 Completed 28 enrolled CSL Behring
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase 1, first-in-human, multi-center, open-label, single dose cohort study to evaluate the safety and tolerability, pharmacokinetics (PK), exploratory pharmacodynamics (PD), and biomarkers of target engagement of CSL889 following single intravenous (IV) doses in subjects with sickle cell disease (SCD). The study involves sequential dose escalation of cohorts with between-group assessments of key safety and PK variables.

Timeline

Start
2021-05-20
Primary completion
2023-07-24
Completion
2023-07-24

Drugs

EvaluationDrugModalityDoseRoute
Subject HEMOPEXIN (HUMAN) Protein / enzyme biologic — Intravenous

Indications