← Back to Search

Anti-sickling agent

ITU512 for Sickle Cell Disease

Phase 1 & 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Part 2: Male and female participants with a diagnosis of sickle cell disease
Part 1: 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
Must not have
Part 2: History of arrhythmias
Part 1: Women of child-bearing potential (WOCBP)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 months

Summary

This trial aims to test the safety, how well the body tolerates, how the drug moves through the body, and the effect of ITU512 on fetal hemoglobin levels in both healthy individuals and

Who is the study for?
This trial is for healthy individuals and those with sickle cell disease. Participants must meet specific health criteria to join, but the exact inclusion and exclusion details are not provided here.
What is being tested?
The study is testing ITU512's safety, how it's tolerated by the body, its movement through the body (pharmacokinetics), effect on food intake, and ability to increase fetal hemoglobin in both healthy people and those with sickle cell disease.
What are the potential side effects?
Specific side effects of ITU512 aren't listed here. Generally, potential side effects can range from mild reactions at the drug administration site to more serious systemic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with sickle cell disease.
Select...
I weigh at least 50 kg and my BMI is between 18.0-32.0.
Select...
I am a healthy adult between 18-55 years old and cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of irregular heartbeats.
Select...
I am a woman who can become pregnant.
Select...
I am currently taking hydroxyurea.
Select...
I have a history of irregular heartbeats.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1A, Part 1B , Part 1C: Dose discontinued due to AE
Part 1A, Part 1B, Part 1C: Incidence of AEs and SAEs
Part 2: Dose intensity
+3 more
Secondary study objectives
Part 1A, Part 1B, Part 2: Change from baseline in Fridericia-corrected Holter QT interval (QTcF)
Part 1A, Part 1B: Area under the plasma concentration-time curve (AUC) of ITU512
Part 1A, Part 1B: Maximum plasma concentration (Cmax) of ITU512
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment2 Interventions
Part 2 in patients with sickle cell disease
Group II: Part 1CExperimental Treatment1 Intervention
Part 1C in healthy participants
Group III: Part 1BExperimental Treatment2 Interventions
Part 1B in healthy participants
Group IV: Part 1AExperimental Treatment2 Interventions
Part 1A in healthy participants
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,919 Previous Clinical Trials
4,254,346 Total Patients Enrolled
~107 spots leftby Nov 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top