A Phase I/II Study of ITU512
Phase 1/2
161
about 5.3 years
12–55
1 site in FL
What this study is about
Researchers are testing the safety, tolerability, and how well ITU512 works in people with sickle cell disease. The trial will also look at whether ITU512 can increase fetal hemoglobin (HbF).
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take ITU512
- 2.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Part 1A, Part 1B , Part 1C: Dose discontinued due to AE, Part 1A, Part 1B, Part 1C: Incidence of AEs and SAEs, Part 2A, Part 2B: Incidence of AEs and SAEs
Secondary: Part 1A, Part 1B, Part 2A, Part 2B: Change from baseline in Fridericia- corrected Holter QT interval (QTcF), Part 1A, Part 1B: Area under the plasma concentration-time curve (AUC) of ITU512, Part 1A, Part 1B: Maximum plasma concentration (Cmax) of ITU512, Part 1A, Part 1B: Renal clearance (CLr), Part 1A, Part 1B: Time to maximum plasma concentration (Tmax) of ITU512, Part 1C: Maximum plasma concentration (Cmax) of ITU512, Part 1C: Time to maximum plasma concentration (Tmax) of ITU512, Part 2A, Part 2B: Change from baseline in total hemoglobin (Hb)