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

RecruitingPhase 1, Phase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Sickle Cell Disease

Interventions: ITU512, Placebo

Countries: United States, Turkey (Türkiye)

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).

Eligibility overview

Sex: ALL

Age: 12 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (9)

Birmingham, Alabama, United States
Miami, Florida, United States
Boston, Massachusetts, United States
Greenville, North Carolina, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Houston, Texas, United States
Ankara, Sihhiye-Altindag, Turkey (Türkiye)
Adana, Yuregir, Turkey (Türkiye)