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

March 1, 2019 updated by: GlycoMimetics Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GMI-1359
Dose escalation
Drug: GMI-1359
Experimental: Placebo
Dose escalation
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlycoMimetics Incorporated

Collaborators

Celerion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GMI-1359-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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