A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
A Phase I/II Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
About This Trial
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).
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
ITU512
ITU512 is an investigational, oral, low molecular weight (LMW) compound.
Placebo
An inactive substance that looks like and is given the same way as ITU512. The effect(s) of ITU512 will be evaluated against the placebo. Placebos are designed as a control and to have no real effect.