Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular effects of intravenous GMI-1070 in the outpatient setting.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlycoMimetics Incorporated; Pfizer

Criteria

Inclusion Criteria:

• Age 18 to 45 years

• Established diagnosis of SCD-SS or SCD-SB0-thal

• At medical baseline, with no evidence of worsening of disease over the last 3 months

• Available and agree to return for follow-up visits for the full duration of the study

• Able to cooperate with study procedures

• Documented and observed written informed consent

Exclusion Criteria:

• Vaso-occlusive crisis

• Recent major surgery, hospitalization, infection, significant bleeding, cerebrovascular accident or seizure, or transfusion

• Currently receiving, or has received within the previous 4 weeks, any other investigational agent

• Pregnant or lactating female; or female of childbearing age unable or unwilling to comply with birth control or abstinence during the course of the study