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Placebo-controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1271 in Healthy Volunteers

Healthy Adult Subjects Clinical Trial

Official title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Intravenous Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects

Clinical Trial Summary

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of single ascending IV doses of GMI-1271 in healthy adult subjects.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States (US). One (1) cohort of 12 subjects (6 active and 6 placebo) and two (2) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. Subjects will participate in only one cohort. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and PK assessment of GMI-1271. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02168595
Study type Interventional
Source GlycoMimetics Incorporated
Contact
Status Completed
Phase Phase 1
Start date June 2014
Completion date April 2015
View Details
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