NCT02931214

Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GMI-1359 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (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 and pharmacokinetics of single ascending IV doses of GMI-1359 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. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of GMI-1359.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GMI-1359
DRUG	Placebo

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-10-01
• Completion: 2018-11-01
• First posted: 2016-10-12
• Last updated: 2019-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study