Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers
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
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Aug 2016
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedMarch 4, 2019
March 1, 2019
1.2 years
September 6, 2016
March 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment related adverse events
Treatment related adverse events as a measure of safety and tolerability of GMI-1359
15 days
Secondary Outcomes (4)
Pharmacokinetics
48 hours
Pharmacokinetics
48 hours
Pharmacokinetics
48 hours
Pharmacodynamics
48 hours
Study Arms (2)
GMI-1359
EXPERIMENTALDose escalation
Placebo
EXPERIMENTALDose escalation
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult male or females, 19-60 years of age (inclusive).
- Medically healthy with no clinically significant screening results.
- 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, and be willing and able to comply with the protocol.
You may not qualify if:
- Subject is mentally or legally incapacitated.
- 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.
- Normal clinical laboratory values.
- Normal heart rate and blood pressure.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlycoMimetics Incorporatedlead
- Celerioncollaborator
Study Sites (1)
Celerion
Lincoln, Nebraska, 68502, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Sterling, MD
Celerion
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2016
First Posted
October 12, 2016
Study Start
August 1, 2016
Primary Completion
October 1, 2017
Study Completion
November 1, 2018
Last Updated
March 4, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share