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โ† Trials
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A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease

RecruitingPhase 1, Phase 2Ages 12 Years - 55 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 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 Key Exclusion Criteria: Part 1 (Healthy participants) * QTcF โ‰ฅ 450 msec (as a mean value of triplicates) * History of arrhythmias * History of significant illness which has not resolved within two (2) weeks prior to initial dosing * Women of child-bearing potential (WOCBP) Part 2 (Sickle Cell Disease) * Current use of hydroxyurea/hydroxycarbamide (HU/HC) * QTcF โ‰ฅ 450 msec (as a mean value of triplicates) * History of arrhythmias Other protocol-defined inclusion/exclusion criteria may apply.
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What it tests

  • ITU512
  • Placebo
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Where

13 sites
University of Alabama Birmingham
Birmingham, United States
Quotient Sciences Sea View
Miami, United States
Boston Childrens Hospital
Boston, United States
Icahn School Of Med At Mount Sinai
New York, United States
Levine Cancer Insitute Carolinas Healthcare System
Charlotte, United States
East Carolina University
Greenville, United States
Childrens Hospital Of Philadelphia
Philadelphia, United States
Lifespan
Providence, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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