drugset / Trial / NCT06546670

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

NCT06546670 ↗

Phase 1/2 Recruiting 161 enrolled Novartis Pharmaceuticals
RandomizedCrossoverDouble-blindTreatment

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).

Timeline

Start
2024-08-15
Primary completion
2028-05-01
Completion
2030-02-19

Drugs

EvaluationDrugModalityDoseRoute
Subject ITU512 Small molecule — Oral

Indications