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

GlycoMimetics Incorporated1 site in 1 country28 target enrollmentJune 2014

ConditionsHealthy Adult Subjects

InterventionsGMI-1271 Placebo

DrugsGMI-1271 Placebo

Overview

Phase: Phase 1
Intervention: GMI-1271
Conditions: Healthy Adult Subjects
Sponsor: GlycoMimetics Incorporated
Enrollment: 28
Locations: 1
Primary Endpoint: Treatment related adverse events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

April 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GlycoMimetics Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult male and/or females, 19 to 60 years of age, inclusive.
•Medically healthy with no clinically significant screening results (e.g., laboratory profiles, medical histories, vital signs, ECGs, physical examination) as deemed by the PI.
•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 (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria

•Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
•History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
•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 subject by their participation in the study.
•Hemoglobin level below the lower limit of normal at screening or check-in.
•Any liver function test (e.g., AST, ALT, bilirubin) 1.5x the upper limit of normal at screening or check-in.
•Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
•Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
•Heart rate is lower than 40 bpm or higher than 99 bpm at screening.
•QTc interval \>430 msec for males or \>450 msec for females, or history of prolonged QT syndrome.
•Estimated creatinine clearance \< 90 ml/min at screening or check-in.