A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Sickle Cell Disease
In brief
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).
Key facts
- Study ID
- NCT06546670
- Run by
- Novartis Pharmaceuticals
- People needed
- 161
- Starts
- 2024-08-15
- Expected to finish
- 2030-02-19
- Last updated by the study team
- 2026-07-20
Who can join
Age: 12 and older, up to 55. Sex: any. Healthy volunteers: accepted.
Where it is running
- Novartis Investigative Site — Adana, Yuregir, Turkey (Türkiye) (enrolling)
- University of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)
- Boston Childrens Hospital — Boston, Massachusetts, United States (enrolling)
- East Carolina University — Greenville, North Carolina, United States (enrolling)
- Childrens Hospital Of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Lifespan — Providence, Rhode Island, United States (enrolling)
- UT Health Science Center — Houston, Texas, United States (enrolling)
- Novartis Investigative Site — Ankara, Sihhiye-Altindag, Turkey (Türkiye) (enrolling)
- Quotient Sciences Sea View — Miami, Florida, United States
Full record on ClinicalTrials.gov
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