A Phase I/II Study of ITU512
Phase 1/2
161
about 5.3 years
12–55
1 site in FL
About this study
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).
Based on ClinicalTrials.gov records.
What participants do
- 1.Take ITU512
- 2.Take Placebo
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
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)