NCT02271113

Phase I Study to Assess Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects

A Randomized, Placebo Controlled, Phase1 Study to Assess the Safety and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: GlycoMimetics Incorporated · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

In this study, the investigators will evaluate the safety, pharmacokinetics and effect on target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of GMI-1271, an E-selectin antagonist, in healthy volunteers.

Detailed description

Investigators will evaluate in a single ascending dose (SAD) and multiple ascending dose (MAD) fashion, the safety, pharmacokinetics and effect on target biomarkers of coagulation, cell adhesion, and leukocyte and platelet activation of GMI-1271, an E-selectin antagonist, in healthy volunteers.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GMI-1271
DRUG	Placebo
DRUG	Enoxaparin Sodium (Lovenox®)

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-10-22
• Last updated: 2018-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study