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RecruitingAccepts healthy volunteersPhase 1/Phase 2

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

Novartis Pharmaceuticals · NCT06546670

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–55 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
161
US sites recruiting
8
Study start
August 15, 2024
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: ITU512; Placebo

Conditions: Sickle Cell Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Alabama Birmingham

    Birmingham, AL 35233

    Site contact: Emily Burke · +1 205 801 3411 · eduke@uabmc.edu

  • Boston Childrens Hospital

    Boston, MA 02215

    Site contact: Nadia Tarhini · +1 617 355 4278 · nadia.tarhini@childrens.harvard.edu

  • Icahn School Of Med At Mount Sinai

    New York, NY 10029

    Site contact: Mitali Pradhan · mitali.pradhan@mountsinai.org

  • Levine Cancer Insitute Carolinas Healthcare System

    Charlotte, NC 28204

    Site contact: Sydney Marks · +1 980 442 2000 · sydney.marks@advocatehealth.org

  • East Carolina University

    Greenville, NC 27858

    Site contact: Kelly Martin · martinke21@ecu.edu

  • Childrens Hospital Of Philadelphia

    Philadelphia, PA 19104

    Site contact: Avi Patel · +1 215 590 9959 · patela67@chop.edu

  • Lifespan

    Providence, RI 02903

    Site contact: Asher Dillman · +1 401 444 5328 · adillmann@brownhealth.org

  • UT Health Science Center

    Houston, TX 77030

    Site contact: Eyuel Baherey · Eyuel.L.Baherey@uth.tmc.edu

Study contacts (from the official record)

  • Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
  • Novartis Pharmaceuticals · +41613241111
All healthy volunteers studies in Alabama →
A Phase I/II Study of ITU512 in Healthy Participants and Patients… (NCT06546670) | Bored Studies