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Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease
NCT04285827 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL CSL889
Study Locations (15)
Other
- Amsterdam UMC Academic Medical Center — Amsterdam
- Erasmus University Medical Center — Rotterdam
- Liverpool University Hospital — Liverpool
- Guys and St. Thomas — London
- University College London Hospital — London
- Manchester University Hospitals NHS Foundation Trust / Manchester Royal Infirmary — Manchester
- Early Phase Unit — Manchester
Illinois
- University of Illinois Hospital and Health Science Systems — Chicago
Maryland
- The Johns Hopkins Hospital — Baltimore
Minnesota
- University of Minnesota — Minneapolis
New York
- Jacobi Medical Center — The Bronx
North Carolina
- Brody School of Medicine at East Carolina University — Greenville
Ohio
- Ohio State University — Columbus
Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2023-07-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04285827
The ClinicalTrials.gov registry entry for NCT04285827 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention — of which CSL889 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04285827 reports 15 study locations spanning 9 distinct geographic areas — top geographies include Other, Illinois, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04285827 about?
NCT04285827 is a clinical study titled "Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease". 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 ...
What is the current status of trial NCT04285827?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-05-20. Estimated completion is 2023-07-24.
What conditions does trial NCT04285827 study?
This clinical trial studies the following conditions: Sickle Cell Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04285827?
The interventions under investigation include: CSL889 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04285827?
This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04285827 being conducted?
This trial has 15 study locations across Illinois, Maryland, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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