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

GlycoMimetics Incorporated1 site in 1 country58 target enrollmentAugust 2016

ConditionsHealthy

InterventionsGMI-1359 Placebo

DrugsGMI-1359 Placebo

Overview

Phase: Phase 1
Intervention: GMI-1359
Conditions: Healthy
Sponsor: GlycoMimetics Incorporated
Enrollment: 58
Locations: 1
Primary Endpoint: Treatment related adverse events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

November 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlycoMimetics Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult male or females, 19-60 years of age (inclusive).
•Medically healthy with no clinically significant screening results.
•Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
•Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study.
•Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol.

Exclusion Criteria

•Subject is mentally or legally incapacitated.
•History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
•Normal clinical laboratory values.
•Normal heart rate and blood pressure.
•Blood donation or significant blood loss within 56 days prior to dosing.
•Plasma donation within 7 days prior to dosing.
•Participation in another clinical trial within 28 days prior to dosing.