Safety, Pharmacokinetic, and Pharmacodynamic Study of NKTT120 in Adult Patients With Stable Sickle Cell Disease (SCD)



Status:Recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 60
Updated:11/8/2014
Start Date:February 2013
Contact:Cheryl Eaton
Email:ceaton@nktrx.com
Phone:7816840290

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A Single Ascending Dose Phase 1 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biologic Activity of Intravenous NKTT120 in Adults With Stable Sickle Cell Disease

The purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics
of NKTT120 in adult patients with stable sickle cell disease.


Inclusion Criteria:

- Age 18 to 50 years

- Subject has a confirmed diagnosis of HbSS or HbSβ0thal

- Subject has stable SCD defined as not having acute VOC, ACS, or other major SCD
associated event during the month prior to enrollment

Exclusion Criteria:

- Subject had an SCD-related VOC or ACS that required hospitalization or treatment in
acute care outpatient setting in the month prior to enrollment

- Subject requires a program of prescheduled regularly administered packed red blood
cell (pRBC) transfusions or Subject received a pRBC transfusion in the month prior to
enrollment

- Subject has evidence of latent or active tuberculosis

- Subject has a major concurrent illness or medical condition

- Subject is pregnant or nursing
We found this trial at
6
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Baltimore, Maryland 21287
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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Milwaukee, Wisconsin 53233
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Milwaukee, WI
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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