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CompletedNCT02931214Updated Mar 4, 2019

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

A Phase 1 interventional study of GMI-1359 and Placebo in Healthy, sponsored by GlycoMimetics Incorporated. Completed at 1 site in United States. Open to participants aged 19 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-04.

Sponsored by GlycoMimetics Incorporated · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2017, 9 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy Subjects
  • Pharmacokinetics
  • Pharmacodynamics
03

In context

Lead sponsor

GlycoMimetics Incorporated is the lead sponsor of 17 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    GMI-1359

    Dose escalation

    Drug: GMI-1359

  • Experimental
    Placebo

    Dose escalation

    Drug: Placebo

Interventions

  • DrugGMI-1359
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Treatment related adverse events

    Treatment related adverse events as a measure of safety and tolerability of GMI-1359

    Time frame: 15 days

Secondary outcomes

  1. Pharmacokinetics

    Cmax (peak plasma concentration)

    Time frame: 48 hours

  2. Pharmacokinetics

    AUC (area under the curve)

    Time frame: 48 hours

  3. Pharmacokinetics

    Tmax (time to peak plasma concentration)

    Time frame: 48 hours

  4. Pharmacodynamics

    CD34 cell measurement

    Time frame: 48 hours

07

Study locations

1 site
  • Celerion
    Lincoln, Nebraska 68502, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02931214
Lead sponsor
GlycoMimetics Incorporated
Collaborators
Celerion
Responsible party
Sponsor
First posted
Oct 12, 2016
Start date
Aug 2016
Primary completion
Oct 2017
Completion
Nov 2018
Last update
Mar 4, 2019

Study contacts

Laura Sterling, MD
principal investigator · Celerion

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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