Tests ITU512 safety and effect in people with sickle cell disease
Tests the new drug ITU512 in healthy people and in people with sickle cell disease.
Plain-language title generated from the registry record
Registry title: A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Key facts
- Where
- Birmingham, Boston, Charlotte, Greenville, Houston, Miami, New York, Philadelphia, and Providence, United StatesSee the 9 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 55 years old?
Source: NCT06546670, who can take part
Where in United States
- University of Alabama BirminghamBirmingham, United StatesTaking people
- Boston Childrens HospitalBoston, United StatesTaking people
- Levine Cancer Insitute Carolinas Healthcare SystemCharlotte, United StatesTaking people
- East Carolina UniversityGreenville, United StatesTaking people
- UT Health Science CenterHouston, United StatesTaking people
- Quotient Sciences Sea ViewMiami, United StatesNo longer taking part
- Icahn School Of Med At Mount SinaiNew York, United StatesTaking people
- Childrens Hospital of PhiladelphiaPhiladelphia, United StatesTaking people
- LifespanProvidence, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06546670EU 2024-515696-35-00
- Record updated
- 27 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Part 1 (Healthy participants); 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; Part 2 (Sickle Cell Disease); Male and female participants with a diagnosis of sickle cell disease.
Exclusion: History of significant illness which has not resolved within two (2) weeks prior to initial dosing; History of arrhythmias; Women of child-bearing potential (WOCBP); Part 2 (Sickle Cell Disease); History of arrhythmias; Other protocol-defined inclusion/exclusion criteria may apply; Part 1 (Healthy participants); QTcF ≥ 450 msec (as a mean value of triplicates); Current use of hydroxyurea/hydroxycarbamide (HU/HC); QTcF ≥ 450 msec (as a mean value of triplicates).