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Clinical Trial Summary

The purpose of this study is to determine the safety and clinical effects of SCD-101 when given to adults with sickle cell disease.


Clinical Trial Description

This is single site, dose- escalation study of SCD-101 in participants with homozygous sickle cell disease (S/S) or S/beta 0 Thalassemia. All participants will be monitored for safety, tolerability, and dose-limiting toxicities. The study is divided into two parts. Part A is an open-label, non-randomized, non-placebo-controlled dose escalation study with a 28-day treatment phase and 14-day follow-up phase with five cohorts . Part B is a randomized, placebo-controlled, confirmatory 2x2 crossover cohort with a 28 day washout between periods, and a 28-day follow-up phase. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02380079
Study type Interventional
Source Invenux, LLC
Contact
Status Active, not recruiting
Phase Phase 1
Start date February 2015
Completion date December 2023

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