A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).

Key facts

Study ID

NCT02703051

Run by

GlycoMimetics Incorporated

People needed

54

Starts

2015-11-01

Expected to finish

2016-08-01

Last updated by the study team

2018-02-27

Who can join

Age: 19 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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 as deemed by the PI.

You may not qualify if…

• History of presence of clinically significant medical condition or disease in the opinion of the PI.
• Alcoholism or drug abuse.
• Liver disease.
• Female subjects who are pregnant or lactating.
• Known history or evidence of active hepatitis A, B, or C or HIV.
• Clinically significant cardiovascular disease.
• Participation in another clinical trial within 28 days prior to the first dose of GMI-1271 or filgrastim, whichever occurs first.

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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