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NCT06546670 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
A Phase 1 study of Sickle Cell Disease, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 161
- Enrollment target
- 1
- Study location
NCT06546670: Recruiting Phase 1 study of Sickle Cell Disease, sponsored by Novartis Pharmaceuticals.
NCT06546670 is a Phase 1 study of Sickle Cell Disease that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 161 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06546670, a Phase 1 study of Sickle Cell Disease, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 161 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ITU512
Study Locations (1)
Florida
- Quotient Sciences Sea View - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2024-08-15 |
| Est. Completion | 2029-11-12 |
| Phase | Phase 1 |
What NCT06546670 shows while recruiting
NCT06546670 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06546670 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06546670 about?
NCT06546670 is a clinical study titled "A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease". 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 a...
What is the current status of trial NCT06546670?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 161 participants. The study started on 2024-08-15. Estimated completion is 2029-11-12.
What conditions does trial NCT06546670 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT06546670?
The interventions under investigation include: Placebo (DRUG), ITU512 (DRUG).
Who is sponsoring clinical trial NCT06546670?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06546670 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06546670's enrollment target sits among peer trials
161 42nd of 213 higher than 172 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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