NCT02168595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

June 17, 2014

Last Update Submit

February 23, 2018

Conditions

Healthy Adult Subjects

Keywords

healthy volunteers, GMI-1271

Outcome Measures

Primary Outcomes (1)

  • Treatment related adverse events

    Treatment related adverse events as a measure of safety and tolerability of GMI-1271 (time frame: Day 1-15)

    Day 1-15

Secondary Outcomes (4)

  • Time of peak plasma concentration (Tmax)

    Day 1-3

  • Pharmacodynamics

    Day 1-3

  • Peak plasma concentration (Cmax)

    Day 1-3

  • Area under the plasma concentration vs time curve (AUC)

    Day 1-3

Study Arms (3)

Cohort 1

EXPERIMENTAL

2 mg/kg GMI-1271 or matching placebo

Drug: GMI-1271Drug: Placebo

Cohort 2

EXPERIMENTAL

5 mg/kg GMI-1271 or matching placebo

Drug: GMI-1271Drug: Placebo

Cohort 3

EXPERIMENTAL

10 mg/kg GMI-1271 or matching placebo

Drug: GMI-1271Drug: Placebo

Interventions

GMI-1271DRUG

GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist

Cohort 1Cohort 2Cohort 3
PlaceboDRUG
Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult male and/or females, 19 to 60 years of age, inclusive.
  • Medically healthy with no clinically significant screening results (e.g., laboratory profiles, medical histories, vital signs, ECGs, physical examination) as deemed by the PI.
  • Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
  • Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

You may not qualify if:

  • 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.
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
  • 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.
  • Hemoglobin level below the lower limit of normal at screening or check-in.
  • Any liver function test (e.g., AST, ALT, bilirubin) 1.5x the upper limit of normal at screening or check-in.
  • Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
  • Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
  • Heart rate is lower than 40 bpm or higher than 99 bpm at screening.
  • QTc interval \>430 msec for males or \>450 msec for females, or history of prolonged QT syndrome.
  • Estimated creatinine clearance \< 90 ml/min at screening or check-in.
  • Blood donation or significant blood loss within 56 days prior to dosing.
  • Plasma donation within 7 days prior to dosing.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

uproleselan

Study Officials

  • Barbara Cook, MD

    Celerion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 20, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

April 1, 2015

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

US(1)