Clinical Trial
Study Details
AG-946, oral encapsulated coated-granules or tablets.
AG-946 matched-placebo, oral encapsulated sugar spheres or tablets.
The purpose of the study is to assess the safety and tolerability of AG-946 in healthy volunteers after oral administration of single ascending doses (SAD) and multiple ascending doses (MAD) of AG-946 over 14 or up to 28 days of dosing, and to identify a range of doses that are safe and pharmacologically active in participants with sickle cell disease. The SAD and MAD parts of the study will be randomized and double-blinded, and will assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of AG-946 as well as the effect of food (SAD only) on the pharmacokinetics (PK) of AG-946. The sickle cell disease (SCD) part of the study will be non-randomized and open-label, and is designed to identify 1 or more safe and tolerable dose(s) of AG-946 with potential activity in the treatment of participants with sickle cell disease (SCD).
Study Overview
Contacts and Locations
University of California San Diego
La Jolla, California 92037
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York 10065
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
PPD Development, LP
Austin, Texas 78744
United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR
Dallas, Texas 75246
United States
University of Texas Health Science Center of Houston
Houston, Texas 77030
United States
Rigshospitalet, Department of Hematology
2100 Copenhagen
Denmark
Hospital Universitario Vall d'Hebron - PPDS
08035 Barcelona
Spain