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Study identifier: NCT06546670 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease

Condition: Sickle Cell Disease  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 1/Phase 2
Planned participants161
Who can joinAll sexes, 12 Years to 55 Years
Healthy volunteersYes

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals  ·  1-888-669-6682  ·  novartis.email@novartis.com

Novartis Pharmaceuticals  ·  +41613241111

Always discuss trial participation with your own doctor first.

Locations (9)

University of Alabama BirminghamBirmingham, Alabama, United StatesRecruiting
Quotient Sciences Sea ViewMiami, Florida, United StatesCompleted
Boston Childrens HospitalBoston, Massachusetts, United StatesRecruiting
East Carolina UniversityGreenville, North Carolina, United StatesRecruiting
Childrens Hospital Of PhiladelphiaPhiladelphia, Pennsylvania, United StatesRecruiting
LifespanProvidence, Rhode Island, United StatesRecruiting
UT Health Science CenterHouston, Texas, United StatesRecruiting
Novartis Investigative SiteAnkara, Sihhiye-Altindag, Turkey (Türkiye)Recruiting
Novartis Investigative SiteAdana, Yuregir, Turkey (Türkiye)Recruiting

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Source record: clinicaltrials.gov/study/NCT06546670