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OpenTrials
Completed

NCT Number: NCT02703051

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

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

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Key information

Conditions

Healthy Volunteers

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

GMI-1271

Drug

Filgrastim

Drug

Placebo injection

Drug

placebo infusion

Drug

Primary outcomes

  1. Measurement of subsets of WBC

    Time frame: 10 days

Secondary outcomes

  1. Number of adverse events as a measure of safety and tolerability

    Time frame: 19 days

Sponsors and collaborators

Lead sponsor

GlycoMimetics Incorporated

Industry

Collaborators

  • Celerion

Registry information

Official study title

A Phase 1, Open-Label Study to Evaluate the Pharmacodynamics, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2016
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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