Actively Recruiting
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Led by Novartis Pharmaceuticals · Updated on 2026-05-14
161
Participants Needed
4
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females of non-childbearing potential aged 18-55 years
- Good health confirmed by medical history, physical exam, vital signs, ECG, and lab tests
- Body weight at least 50 kg and BMI between 18.0 and 32.0 kg/m2 for healthy participants
- Male and female participants diagnosed with sickle cell disease
You will not qualify if you...
- QTcF interval 450 msec or higher (mean of triplicate ECGs) in healthy participants and patients
- History of arrhythmias
- Significant illness unresolved within 2 weeks before first dosing for healthy participants
- Women of child-bearing potential excluded from healthy participant group
- Current use of hydroxyurea or hydroxycarbamide in patients with sickle cell disease
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Quotient Sciences Sea View
Miami, Florida, United States, 33126
Completed
3
Boston Childrens Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Lifespan
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
6
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