ITU512 for Sickle Cell Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
If you are currently using hydroxyurea or hydroxycarbamide, you will need to stop taking it to participate in this trial. The protocol does not specify about other medications.
Are You a Good Fit for This Trial?
This trial is for healthy individuals and those with sickle cell disease. Participants must meet specific health criteria to join, but the exact inclusion and exclusion details are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
First-in-human study to assess safety, tolerability, and pharmacokinetics of ITU512 in healthy participants
Phase II Treatment
Evaluation of safety, tolerability, pharmacokinetics, and efficacy of ITU512 in patients with sickle cell disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Optional extension part for continued evaluation of ITU512 in patients with sickle cell disease
What Are the Treatments Tested in This Trial?
Interventions
- ITU512
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD