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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06546670
The ClinicalTrials.gov registry entry for NCT06546670 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (45% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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