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
The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects.
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.
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.
Exclusion Criteria:
Dose escalation
Drug: GMI-1359
Dose escalation
Drug: Placebo
Treatment related adverse events
Treatment related adverse events as a measure of safety and tolerability of GMI-1359
Time frame: 15 days
Pharmacokinetics
Cmax (peak plasma concentration)
Time frame: 48 hours
Pharmacokinetics
AUC (area under the curve)
Time frame: 48 hours
Pharmacokinetics
Tmax (time to peak plasma concentration)
Time frame: 48 hours
Pharmacodynamics
CD34 cell measurement
Time frame: 48 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlycoMimetics Incorporated