A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
NCT06546670
This study is recruiting at 8 US sites in 7 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Sickle Cell Disease
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1/2
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- Novartis Pharmaceuticals
- Last updated on ClinicalTrials.gov
- October 9, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- University of Alabama Birmingham · Birmingham, AL
Massachusetts · 1
- Boston Childrens Hospital · Boston, MA
New York · 1
- Icahn School Of Med At Mount Sinai · New York, NY
North Carolina · 2
- Levine Cancer Insitute Carolinas Healthcare System · Charlotte, NC
- East Carolina University · Greenville, NC
Pennsylvania · 1
- Childrens Hospital Of Philadelphia · Philadelphia, PA
Rhode Island · 1
- Lifespan · Providence, RI
Texas · 1
- UT Health Science Center · Houston, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.