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

Overview

The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2017

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.

Interventions

  • Drug: GMI-1359
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: GMI-1359
    • Dose escalation
  • Experimental: Placebo
    • Dose escalation

Clinical Trial Outcome Measures

Primary Measures

  • Treatment related adverse events
    • Time Frame: 15 days
    • Treatment related adverse events as a measure of safety and tolerability of GMI-1359

Secondary Measures

  • Pharmacokinetics
    • Time Frame: 48 hours
    • Cmax (peak plasma concentration)
  • Pharmacokinetics
    • Time Frame: 48 hours
    • AUC (area under the curve)
  • Pharmacokinetics
    • Time Frame: 48 hours
    • Tmax (time to peak plasma concentration)
  • Pharmacodynamics
    • Time Frame: 48 hours
    • CD34 cell measurement

Participating in This Clinical Trial

Inclusion Criteria

1. Healthy adult male or females, 19-60 years of age (inclusive). 2. Medically healthy with no clinically significant screening results. 3. Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method 4. Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study. 5. Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol. Exclusion Criteria:

1. Subject is mentally or legally incapacitated. 2. 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. 3. Normal clinical laboratory values. 4. Normal heart rate and blood pressure. 5. Blood donation or significant blood loss within 56 days prior to dosing. 6. Plasma donation within 7 days prior to dosing. 7. Participation in another clinical trial within 28 days prior to dosing.

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlycoMimetics Incorporated
  • Collaborator
    • Celerion
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Laura Sterling, MD, Principal Investigator, Celerion

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