The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512. This will be the first evaluation of the potential therapeutic effect of ITU512 in healthy participants and patients with sickle cell disease (SCD).
Healthy male participants and female participants of non-childbearing potential between 18-55 years of age
In good health as determined by the investigator's assessment of medical history, physical examination, vital signs, ECG, and laboratory tests
Participants must weigh at least 50 kg at screening and first baseline (admission) and must have a body mass index (BMI) within the range of 18.0-32.0 kg/m2 inclusive.
QTcF ≥ 450 msec (as a mean value of triplicates)
History of arrhythmias
History of significant illness which has not resolved within two (2) weeks prior to initial dosing
Women of child-bearing potential (WOCBP)
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Treatment groupsSee each treatment group below.
Novartis Pharmaceuticals
Lead sponsor