Sickle Cell DiseasePhase 1/2NCT06546670
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
A Phase 1/2 study testing ITU512 in people with Sickle Cell Disease, run by Novartis Pharmaceuticals at 14 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- ITU512
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 15 Aug 2024to 27 May 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
14 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
14 sites in 3 countries
United States9 sites, 8 recruiting
- Recruiting
University of Alabama Birmingham
Birmingham, Alabama, 35233
Emily Burke, +1 205 801 3411, eduke@uabmc.edu
Julie Kanter-Washko
- Recruiting
Boston Childrens Hospital
Boston, Massachusetts, 02215
Nadia Tarhini, +1 617 355 4278, nadia.tarhini@childrens.harvard.edu
Matthew M Heeney
- Recruiting
Levine Cancer Insitute Carolinas Healthcare System
Charlotte, North Carolina, 28204
Sydney Marks, +1 980 442 2000, sydney.marks@advocatehealth.org
Payal Desai
- Recruiting
East Carolina University
Greenville, North Carolina, 27858
Kelly Martin, martinke21@ecu.edu
Darla Liles
- Recruiting
UT Health Science Center
Houston, Texas, 77030
Eyuel Baherey, Eyuel.L.Baherey@uth.tmc.edu
Modupe Idowu
- Completed
Quotient Sciences Sea View
Miami, Florida, 33126
- Recruiting
Icahn School Of Med At Mount Sinai
New York, New York, 10029
Mitali Pradhan, mitali.pradhan@mountsinai.org
Susanna Curtis
- Recruiting
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
Avi Patel, +1 215 590 9959, patela67@chop.edu
Alexis A Thompson
- Recruiting
Lifespan
Providence, Rhode Island, 02903
Asher Dillman, +1 401 444 5328, adillmann@brownhealth.org
Patrick Mc Gann
Brazil3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14048-900
- Recruiting
Novartis Investigative Site
São Paulo, São Paulo, 01232-010
- Recruiting
Novartis Investigative Site
São Paulo, 05403-000
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Adana, Yuregir, 01250
- Recruiting
Novartis Investigative Site
Ankara, Sihhiye Altindag, 06230
About this study
Official title: A Phase I/II Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
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).
Read the detailed description
This is a global, randomized, Phase I/II study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary food effect of single-agent ITU512 in adult healthy participants, and safety, tolerability, PK, PD, and efficacy of ITU512 in adolescent and adult patients with sickle cell disease (SCD). The study consists of a first-in-human Phase I study (Part 1) in healthy participants, and a Phase II study (Part 2) in patients with SCD.
Part 1 will comprise of Part 1A, Part 1B, and Part 1C. Part 2 will include Part 2A and 2B and may also include an extension part (Part 2C).
- Conditions
- Sickle Cell Disease
- Being tested
- ITU512, Placebo
- Keywords
- ITU512, Low molecular weight, Small molecule, Sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITU512Drug
ITU512 is an investigational, oral, low molecular weight (LMW) compound.
PlaceboDrug
An inactive substance that looks like and is given the same way as ITU512. The effect(s) of ITU512 will be evaluated against the placebo. Placebos are designed as a control and to have no real effect.
| Study group | Role | What they receive |
|---|---|---|
| Part 1A | Experimental | Part 1A in healthy participants Receives: Drug: ITU512; Drug: Placebo |
| Part 1B | Experimental | Part 1B in healthy participants Receives: Drug: ITU512; Drug: Placebo |
| Part 1C | Experimental | Part 1C in healthy participants Receives: Drug: ITU512 |
| Part 2A | Experimental | Part 2A in patients with sickle cell disease Receives: Drug: ITU512; Drug: Placebo |
| Part 2B | Experimental | Part 2B in patients with sickle cell disease Receives: Drug: ITU512; Drug: Placebo |
| Part 2C | Experimental | Optional extension in patients with sickle cell disease Receives: Drug: ITU512 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1A, Part 1B, Part 1C: Incidence of AEs and SAEs
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Measured: Up to approximately 60 days
Part 1A, Part 1B , Part 1C: Dose discontinued due to AE
Number of participants with dose discontinuation due to AEs
Measured: Up to 30 days
Part 2A, Part 2B: Incidence of AEs and SAEs
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Measured: Up to 5 months
Part 2A, Part 2B: Dose interruptions and reductions
Number of participants with dose interruptions or reductions of ITU512
Measured: Up to 4 months
Part 2A, Part 2B: Dose intensity
Dose intensity of ITU512 is computed as the ratio of actual cumulative dose received and actual duration of exposure
Measured: Up to 4 months
Part 2B: Fetal hemoglobin (HbF)%
Assessment of fetal hemoglobin expression by measuring fetal hemoglobin (HbF)% by high-performance liquid chromatography (HPLC) assay
Measured: Month 4
Secondary outcomes (13)
Part 1A, Part 1B: Area under the plasma concentration-time curve (AUC) of ITU512
Pharmacokinetic (PK) parameters calculated based on ITU512 plasma concentrations by non-compartmental methods
Measured: From pre-dose up to 144 hours post-dose on Day 1 (Part 1A) and from pre-dose up to 24 hours post-dose on Day 1 and Day 10 (Part 1B)
Part 1A, Part 1B: Maximum plasma concentration (Cmax) of ITU512
PK parameters calculated based on ITU512 plasma concentrations by non-compartmental methods
Measured: From pre-dose up to 144 hours post-dose on Day 1 (Part 1A) and from pre-dose up to 24 hours post-dose on Day 1 and Day 10 (Part 1B)
Part 1A, Part 1B: Time to maximum plasma concentration (Tmax) of ITU512
PK parameters calculated based on ITU512 plasma concentrations by non-compartmental methods
Measured: From pre-dose up to 144 hours post-dose on Day 1 (Part 1A) and from pre-dose up to 24 hours post-dose on Day 1 and Day 10 (Part 1B)
Part 1A, Part 1B: Renal clearance (CLr)
PK parameters calculated based on ITU512 urine concentrations by non-compartmental methods. The renal clearance (CLr) may be determined based on AUC and amount of drug excreted into urine (Ae) available for the same time period.
Measured: From pre-dose up to 48 hours post-dose on Day 1 (Part 1A) and from pre-dose up to 24 hours post-dose on Day 1 and Day 10 (Part 1B)
Part 2A, Part 2B: Plasma concentrations of ITU512
ITU512 concentration in plasma determined in non-placebo treated participants by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method
Measured: From pre-dose up to 4, 6 or 8 hours post-dose on Day 1 at Month 1 and Month 2
Part 2A, Part 2B: Urine concentrations of ITU512
ITU512 concentration in urine determined in non-placebo treated participants by a LC-MS/MS method
Measured: From pre-dose up to 4 or 8 hours post-dose on Day 1 at Month 1
Part 2A: Fetal hemoglobin (HbF)%
Assessment of fetal hemoglobin expression by measuring fetal hemoglobin (HbF)% by HPLC assay
Measured: Up to 4 months
Part 2A, Part 2B: Change from baseline in total hemoglobin (Hb)
Change from baseline in total hemoglobin (Hb) over time measured in blood samples
Measured: Baseline, up to 4 months
Part 1A, Part 1B, Part 2A, Part 2B: Change from baseline in Fridericia- corrected Holter QT interval (QTcF)
Real-time 12-lead safety ECGs will be locally collected and evaluated. Change from baseline in QTcF with respect to PK parameters and/or ITU512 concentrations will be assessed
Measured: Up to 4 months
Part 1C: Area under the plasma concentration-time curve from time 0 up to the time of the last quantifiable concentration (AUClast) of ITU512
PK parameters calculated based on ITU512 plasma concentrations by non-compartmental methods
Measured: From pre-dose up to 144 hours post-dose
Part 1C: Area under the plasma concentration-time curve from time 0 up to infinity (AUCinf) of ITU512
PK parameters calculated based on ITU512 plasma concentrations by non-compartmental methods
Measured: From pre-dose up to 144 hours post-dose
Part 1C: Maximum plasma concentration (Cmax) of ITU512
PK parameters calculated based on ITU512 plasma concentrations by non-compartmental methods
Measured: From pre-dose up to 144 hours post-dose
Part 1C: Time to maximum plasma concentration (Tmax) of ITU512
PK parameters calculated based on ITU512 plasma concentrations by non-compartmental methods
Measured: From pre-dose up to 144 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start15 Aug 2024
- Primary completion1 May 2028 (estimated)
- Study completion27 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 161 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546670
- Sponsor's protocol ID
- CITU512A12101
- Other IDs
- 2024-515696-35-00
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06546670
- Acronym / sponsor ID
- CITU512A12101
- Conditions
- Sickle Cell Disease
- Keywords
- ITU512, Low molecular weight, Small molecule, Sickle cell disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 161 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 27 May 2030 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a global, randomized, Phase I/II study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary food effect of single-agent ITU512 in adult healthy participants, and safety, tolerability, PK, PD, and efficacy of ITU512 in adolescent and adult patients with sickle cell disease (SCD). The study consists of a first-in-human Phase I study (Part 1) in healthy participants, and a Phase II study (Part 2) in patients with SCD.
Part 1 will comprise of Part 1A, Part 1B, and Part 1C. Part 2 will include Part 2A and 2B and may also include an extension part (Part 2C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1A | Experimental | Drug: ITU512, Drug: PlaceboPart 1A in healthy participants |
| Part 1B | Experimental | Drug: ITU512, Drug: PlaceboPart 1B in healthy participants |
| Part 1C | Experimental | Drug: ITU512Part 1C in healthy participants |
| Part 2A | Experimental | Drug: ITU512, Drug: PlaceboPart 2A in patients with sickle cell disease |
| Part 2B | Experimental | Drug: ITU512, Drug: PlaceboPart 2B in patients with sickle cell disease |
| Part 2C | Experimental | Drug: ITU512Optional extension in patients with sickle cell disease |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITU512ITU512 is an investigational, oral, low molecular weight (LMW) compound. | Drug | Part 1A, Part 1B, Part 1C, Part 2A, Part 2B, Part 2C |
| PlaceboAn inactive substance that looks like and is given the same way as ITU512. The effect(s) of ITU512 will be evaluated against the placebo. Placebos are designed as a control and to have no real effect. | Drug | Part 1A, Part 1B, Part 2A, Part 2B |
Primary outcome
Part 1A, Part 1B, Part 1C: Incidence of AEs and SAEs
Time frame: Up to approximately 60 days
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Part 1A, Part 1B , Part 1C: Dose discontinued due to AE
Time frame: Up to 30 days
Number of participants with dose discontinuation due to AEs
Part 2A, Part 2B: Incidence of AEs and SAEs
Time frame: Up to 5 months
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Part 2A, Part 2B: Dose interruptions and reductions
Time frame: Up to 4 months
Number of participants with dose interruptions or reductions of ITU512
Part 2A, Part 2B: Dose intensity
Time frame: Up to 4 months
Dose intensity of ITU512 is computed as the ratio of actual cumulative dose received and actual duration of exposure
Part 2B: Fetal hemoglobin (HbF)%
Time frame: Month 4
Assessment of fetal hemoglobin expression by measuring fetal hemoglobin (HbF)% by high-performance liquid chromatography (HPLC) assay
13 secondary outcomes
Part 1A, Part 1B: Area under the plasma concentration-time curve (AUC) of ITU512
Time frame: From pre-dose up to 144 hours post-dose on Day 1 (Part 1A) and from pre-dose up to 24 hours post-dose on Day 1 and Day 10 (Part 1B)
Part 1A, Part 1B: Maximum plasma concentration (Cmax) of ITU512
Time frame: From pre-dose up to 144 hours post-dose on Day 1 (Part 1A) and from pre-dose up to 24 hours post-dose on Day 1 and Day 10 (Part 1B)
Part 1A, Part 1B: Time to maximum plasma concentration (Tmax) of ITU512
Time frame: From pre-dose up to 144 hours post-dose on Day 1 (Part 1A) and from pre-dose up to 24 hours post-dose on Day 1 and Day 10 (Part 1B)
Part 1A, Part 1B: Renal clearance (CLr)
Time frame: From pre-dose up to 48 hours post-dose on Day 1 (Part 1A) and from pre-dose up to 24 hours post-dose on Day 1 and Day 10 (Part 1B)
Part 2A, Part 2B: Plasma concentrations of ITU512
Time frame: From pre-dose up to 4, 6 or 8 hours post-dose on Day 1 at Month 1 and Month 2
Part 2A, Part 2B: Urine concentrations of ITU512
Time frame: From pre-dose up to 4 or 8 hours post-dose on Day 1 at Month 1
Part 2A: Fetal hemoglobin (HbF)%
Time frame: Up to 4 months
Part 2A, Part 2B: Change from baseline in total hemoglobin (Hb)
Time frame: Baseline, up to 4 months
Part 1A, Part 1B, Part 2A, Part 2B: Change from baseline in Fridericia- corrected Holter QT interval (QTcF)
Time frame: Up to 4 months
Part 1C: Area under the plasma concentration-time curve from time 0 up to the time of the last quantifiable concentration (AUClast) of ITU512
Time frame: From pre-dose up to 144 hours post-dose
Part 1C: Area under the plasma concentration-time curve from time 0 up to infinity (AUCinf) of ITU512
Time frame: From pre-dose up to 144 hours post-dose
Part 1C: Maximum plasma concentration (Cmax) of ITU512
Time frame: From pre-dose up to 144 hours post-dose
Part 1C: Time to maximum plasma concentration (Tmax) of ITU512
Time frame: From pre-dose up to 144 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ITU512 in people with Sickle Cell Disease, run by Novartis Pharmaceuticals at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Brazil, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1A, Part 1B, Part 1C: Incidence of AEs and SAEs (time frame: Up to approximately 60 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.