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Placebo-controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1271 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02168595
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : February 27, 2018
Information provided by (Responsible Party):
GlycoMimetics Incorporated

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.

Condition or disease Intervention/treatment Phase
Healthy Adult Subjects Drug: GMI-1271 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 (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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: 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
Study Start Date : June 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: Cohort 1
2 mg/kg GMI-1271 or matching placebo
Drug: GMI-1271
GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist

Drug: Placebo
Experimental: Cohort 2
5 mg/kg GMI-1271 or matching placebo
Drug: GMI-1271
GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist

Drug: Placebo
Experimental: Cohort 3
10 mg/kg GMI-1271 or matching placebo
Drug: GMI-1271
GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist

Drug: Placebo

Primary Outcome Measures :
  1. Treatment related adverse events [ Time Frame: Day 1-15 ]
    Treatment related adverse events as a measure of safety and tolerability of GMI-1271 (time frame: Day 1-15)

Secondary Outcome Measures :
  1. Time of peak plasma concentration (Tmax) [ Time Frame: Day 1-3 ]
  2. Pharmacodynamics [ Time Frame: Day 1-3 ]
    WBC count, biomarkers to assess pharmacodynamics of single IV dose of GMI-1271 (time frame: Day 1-3)

  3. Peak plasma concentration (Cmax) [ Time Frame: Day 1-3 ]
  4. Area under the plasma concentration vs time curve (AUC) [ Time Frame: Day 1-3 ]

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
  3. 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.
  4. Hemoglobin level below the lower limit of normal at screening or check-in.
  5. Any liver function test (e.g., AST, ALT, bilirubin) 1.5x the upper limit of normal at screening or check-in.
  6. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
  7. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
  8. Heart rate is lower than 40 bpm or higher than 99 bpm at screening.
  9. QTc interval >430 msec for males or >450 msec for females, or history of prolonged QT syndrome.
  10. Estimated creatinine clearance < 90 ml/min at screening or check-in.
  11. Blood donation or significant blood loss within 56 days prior to dosing.
  12. Plasma donation within 7 days prior to dosing.
  13. Participation in another clinical trial within 28 days prior to dosing. The 28-day window will be derived from the date of the last study procedure (such as last blood collection or dosing) in the previous study to Day 1 of Period 1 of the current study.

Note: If an increase (>1.5 x N) in bilirubin is present at screening additional liver function tests may be performed (such as ALT, AST, ALP, albumin, and direct and indirect bilirubin) to determine if the increase of bilirubin is due to Gilbert-Meulengracht syndrome. If consistent with Gilbert's syndrome, the Investigator and Sponsor may decide not to consider this as an exclusion. Any such decision will be documented in the study record.

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 identifier (NCT number): NCT02168595

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United States, Nebraska
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
GlycoMimetics Incorporated
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Principal Investigator: Barbara Cook, MD Celerion
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Responsible Party: GlycoMimetics Incorporated Identifier: NCT02168595    
Other Study ID Numbers: GMI-1271-101
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

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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 volunteers, GMI-1271