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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT06546670

Registry updated: 2026-10-20
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Description

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).

Interventions

  • ITU512 (Drug)
    ITU512 is an investigational, oral, low molecular weight (LMW) compound.
  • Placebo (Drug)
    An inactive substance that looks like and is given the same way as ITU512. The effect(s) of ITU512 will be evaluated against the placebo. Placebos are designed as a control and to have no real effect.

Eligibility criteria

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 ≥ 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 ≥ 450 msec (as a mean value of triplicates) * History of arrhythmias Other protocol-defined inclusion/exclusion criteria may apply.

Conditions

Sickle Cell Disease

Locations

  • University of Alabama Birmingham — Birmingham, Alabama, United States
  • Quotient Sciences Sea View — Miami, Florida, United States
  • Boston Childrens Hospital — Boston, Massachusetts, United States
  • Icahn School Of Med At Mount Sinai — New York, New York, United States
  • Levine Cancer Insitute Carolinas Healthcare System — Charlotte, North Carolina, United States
  • East Carolina University — Greenville, North Carolina, United States
  • Childrens Hospital Of Philadelphia — Philadelphia, Pennsylvania, United States
  • Lifespan — Providence, Rhode Island, United States
  • UT Health Science Center — Houston, Texas, United States
  • Novartis Investigative Site — Ribeirão Preto, São Paulo, Brazil
  • Novartis Investigative Site — São Paulo, São Paulo, Brazil
  • Novartis Investigative Site — Ankara, Sihhiye Altindag, Turkey (Türkiye)
  • Novartis Investigative Site — Adana, Yuregir, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record