Trials / Completed
CompletedNCT04285827
Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease
A 2-Part, Phase 1, Multi-Center, Single-Dose, Open Label, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CSL889 in Adult Patients With Sickle Cell Disease
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CSL889 | Administered as an IV infusion |
Timeline
- Start date
- 2021-05-20
- Primary completion
- 2023-07-24
- Completion
- 2023-07-24
- First posted
- 2020-02-26
- Last updated
- 2023-09-06
Locations
15 sites across 3 countries: United States, Netherlands, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04285827. Inclusion in this directory is not an endorsement.