NCT02168595

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: GlycoMimetics Incorporated · Industry
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	GMI-1271	GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist
DRUG	Placebo

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-08-01
• Completion: 2015-04-01
• First posted: 2014-06-20
• Last updated: 2018-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study