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

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ClinicalTrials.gov Identifier: NCT02931214
Recruitment Status : Completed
First Posted : October 12, 2016
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
GlycoMimetics Incorporated

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: GMI-1359 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : November 2018

Arm Intervention/treatment
Experimental: GMI-1359
Dose escalation
Drug: GMI-1359
Experimental: Placebo
Dose escalation
Drug: Placebo



Primary Outcome Measures :
  1. Treatment related adverse events [ Time Frame: 15 days ]
    Treatment related adverse events as a measure of safety and tolerability of GMI-1359


Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 48 hours ]
    Cmax (peak plasma concentration)

  2. Pharmacokinetics [ Time Frame: 48 hours ]
    AUC (area under the curve)

  3. Pharmacokinetics [ Time Frame: 48 hours ]
    Tmax (time to peak plasma concentration)

  4. Pharmacodynamics [ Time Frame: 48 hours ]
    CD34 cell measurement



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931214


Locations
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United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
GlycoMimetics Incorporated
Celerion
Investigators
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Principal Investigator: Laura Sterling, MD Celerion

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Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02931214     History of Changes
Other Study ID Numbers: GMI-1359-101
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlycoMimetics Incorporated:
Healthy Subjects
Pharmacokinetics
Pharmacodynamics