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RECRUITING
NCT06546670
PHASE1/PHASE2

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

12 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

161

Start Date

2024-08-15

Completion Date

2029-11-12

Last Updated

2026-01-29

Healthy Volunteers

Yes

Interventions

DRUG

ITU512

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

DRUG

Placebo

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.

Locations (1)

Quotient Sciences Sea View

Miami, Florida, United States