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

Clinical Trial
Study Details
Enrollment
28
Interventions
Description

Administered as an IV infusion

Name
CSL889
Type
Biological
Phase
Phase 1
Status
COMPLETED
Study ID #
NCT04285827
Study Type
Interventional
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.

Study Overview
Conditions
Contacts and Locations
Locations
Facility

University of Illinois Hospital and Health Science Systems
Chicago, Illinois 60612
United States

GeoPoint
41.85003, -87.65005
Facility

The Johns Hopkins Hospital
Baltimore, Maryland 21287
United States

GeoPoint
39.29038, -76.61219
Facility

University of Minnesota
Minneapolis, Minnesota 55455
United States

GeoPoint
44.97997, -93.26384
Facility

Jacobi Medical Center
The Bronx, New York 10461
United States

GeoPoint
40.84985, -73.86641
Facility

Brody School of Medicine at East Carolina University
Greenville, North Carolina 27834
United States

GeoPoint
35.61266, -77.36635
Facility

Ohio State University
Columbus, Ohio 43201
United States

GeoPoint
39.96118, -82.99879
Facility

UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States

GeoPoint
40.44062, -79.99589
Facility

Medical University of South Carolina
Charleston, South Carolina 29425
United States

GeoPoint
32.77632, -79.93275
Facility

Amsterdam UMC Academic Medical Center
Amsterdam
Netherlands

GeoPoint
52.37403, 4.88969
Facility

Erasmus University Medical Center
Rotterdam
Netherlands

GeoPoint
51.9225, 4.47917
Facility

Liverpool University Hospital
Liverpool
United Kingdom

GeoPoint
53.41058, -2.97794
Facility

Guys and St. Thomas
London
United Kingdom

GeoPoint
51.50853, -0.12574
Facility

University College London Hospital
London
United Kingdom

GeoPoint
51.50853, -0.12574
Facility

Manchester University Hospitals NHS Foundation Trust / Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom

GeoPoint
53.48095, -2.23743
Facility

Early Phase Unit
Manchester
United Kingdom

GeoPoint
53.48095, -2.23743