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A Phase I, Multi-Center, Open Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmakokinetics of CSL889 in Adult Patients with Stable Sickle Cell Disease

Recruiting

This study is being done to measure levels of CSL889 in the blood and see how well it is tolerated. The study will also look for changes in several blood tests related to sickle cell disease to see how the study drug might affect these measures.

I'm interested

All
18 Years to 60 Years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Diagnosis of SCD characterized by HbSS or SCD characterized by the compound heterozygous state of the βS mutation with β0 thalassemia mutations (HbSβ0)
• Aged 18 to 60 years, inclusive
• Stable SCD for at least 30 days before CSL889 infusion (Part A) or subject hospitalized for uncomplicated VOC (Part B)
• Subject is either not taking hydroxyurea and / or L-glutamine, or subject has been taking hydroxyurea and / or L-glutamine for at least 30 days before Day 1 on a stable, well tolerated regimen that is planned to continue without change throughout the study
Exclusion Criteria:

• History of primary hemorrhagic stroke
• History or evidence of inherited bleeding diathesis or significant coagulopathy at risk for bleeding
• Weight >110 kg (242 lbs)
• Surgery within 30 days before Day 1 or any preplanned surgeries during the study (minor surgeries may be permitted under local anesthesia before screening, with permission of the medical monitor)
• Female subjects who are pregnant or breastfeeding
• Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of CSL889.
• Treatment with any other drug / biologic that is newly approved for SCD during the conduct of this study within 90 days before Day 1.
• Treatment with another investigational product within 30 days or within 5 half-lives of the product (whichever is greater) before Day 1
• Vaccination within 30 days before Day 1, or planned vaccination during the study
• Body-mass index < 16 kg/m2 or weight < 50 kg (110 lbs)
• History of anaphylactic-type reactions, transfusion related reaction, asthma, or autoimmune disease

Biological: CSL889

Sickle Cell Disease

Alexander Boucher - bouch070@umn.edu
Alexander Boucher
Phase 1
STUDY00012191
NCT04285827
See this study on ClinicalTrials.gov

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