Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing ITU512 for Sickle Cell Disease

This study wants to measure 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).

Official registry: https://clinicaltrials.gov/study/NCT06546670 · Novartis Pharmaceuticals · enrollment listed as 161

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ITU512, or Placebo. The registry lists allocation as randomized. This study wants to measure the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.

They plan to enroll about 161 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: ITU512, Placebo

Primary outcome (registry wording): Part 1A, Part 1B, Part 1C: Incidence of AEs and SAEs

Who it is for (from inclusion criteria)

  • Ages 12 Years to 55 Years
  • 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 (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

Public study contact (from the registry)

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

14 listed

+ 5 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseWashington D.C., District of Columbia
Natural History of Sickle Cell Disease

This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated.

NCT00081523 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)

RecruitingNot a traditional drug phaseBethesda, Maryland
Blood Sampling for Research Related to Sickle Cell Disease

This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body.

NCT00542230 · Official ClinicalTrials.gov record · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

FAQ about this NCT record

Is NCT06546670 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06546670?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06546670?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary