Sickle Cell Disease study: ITU512
Official title A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
ClinicalTrials.gov ID: NCT06546670
What this study is testing
What is ITU512?
ITU512 is an investigational oral medicine being studied as a potential treatment for sickle cell disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether ITU512 is safe and how it works in the body. It also checks if the drug helps make a specific type of blood protein.
- Who it's for
- You may be able to join if you are healthy or have sickle cell disease.
- What's involved
- You would take the study drug and have blood tests. The team will check how your body handles the medicine.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Key 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...
You likely can't join if
- 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)
See the full eligibility criteria
- Key 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 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Greenville, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Ribeirão Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, Brazil
- Ankara, Sihhiye Altindag, Turkey (Türkiye)
- Adana, Yuregir, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Boston, Massachusetts, United States; New York, New York, United States; Charlotte, North Carolina, United States; Greenville, North Carolina, United States; Philadelphia, Pennsylvania, United States and 7 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.