RecruitingPhase 1Phase 2NCT06546670

A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease

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

Sponsor

Novartis Pharmaceuticals

Enrollment

161 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Sickle Cell Disease

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. This will be the first evaluation of the potential therapeutic effect of ITU512 in healthy participants and patients with sickle cell disease (SCD).

Eligibility

Min Age: 12 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ITU512 and a drug called Placebo for people with sickle cell disease. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 12 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGITU512

ITU512 is an investigational, oral, low molecular weight (LMW) compound.

DRUGPlacebo

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.