NCT06546670RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 161 (estimated)
- First submitted
- 16 Jul 2024
- Start date
- 15 Aug 2024
- Primary completion date
- 1 May 2028
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Sickle cell disease
- NCT number
- NCT06546670
- EU CT number
- 2024-515696-35-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 161
- From 15 Aug 2024 to the primary completion date, 1 May 2028
- 13 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of significant illness which has not resolved within two (2) weeks prior to initial dosing
Other illness
- 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.
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 12 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| University of Alabama Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Boston Childrens Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Levine Cancer Insitute Carolinas Healthcare System Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| East Carolina University Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| UT Health Science Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Quotient Sciences Sea View Coordinator of this site? Confirm its status | Miami | United States | Completed |
| Icahn School Of Med At Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Childrens Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Lifespan Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Recruiting |
| - Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.