drugset / Trial / NCT06546670
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
RandomizedCrossoverDouble-blindTreatment
Summary
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).
Timeline
- Start
- 2024-08-15
- Primary completion
- 2028-05-01
- Completion
- 2030-02-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ITU512 | Small molecule | — | Oral |