drugset / Trial / NCT04285827
Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HEMOPEXIN (HUMAN) | Protein / enzyme biologic | — | Intravenous |