Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546670
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
A Phase III Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Clinical Study to Investigate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Efficacy of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This is a global randomized Phase III study to assess the safety tolerability pharmacokinetics PK pharmacodynamics PD and preliminary food effect of single-agent ITU512 in adult healthy participants and safety tolerability PK PD and efficacy of ITU512 in adolescent and adult patients with sickle cell disease SCD The study consists of a first-in-human Phase I study Part 1 in healthy participants and a Phase II study Part 2 in patients with SCD
Part 1 will comprise of Part 1A Part 1B and Part 1C Part 2 may include an extension part
Part 1 will comprise of Part 1A Part 1B and Part 1C Part 2 may include an extension part
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None