A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Recruiting
Phase 1
Phase 2
Interventional Study
Sickle Cell Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 12 – 55
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 161 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
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 laborat…
Contacts
Novartis Pharmaceuticals
+41613241111
CONTACT