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Trial record 6 of 9 for:    gmi-1271

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

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ClinicalTrials.gov Identifier: NCT02703051
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
GlycoMimetics Incorporated

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: GMI-1271 Drug: Filgrastim Drug: Placebo Injection Drug: Placebo Infusion Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official 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
Actual Study Start Date : November 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GMI-1271
GMI-1271
Drug: GMI-1271
Drug: Placebo Injection
Active Comparator: Filgrastim
Filgrastim
Drug: Filgrastim
Drug: Placebo Infusion
Experimental: GMI-1271 with Filgrastim
GMI-1271 with Filgrastim
Drug: GMI-1271
Drug: Filgrastim



Primary Outcome Measures :
  1. Measurement of subsets of WBC [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Number of adverse events as a measure of safety and tolerability [ Time Frame: 19 days ]


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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult male and/or females, 19 to 60 years of age, inclusive.
  2. Medically healthy with no clinically significant screening results as deemed by the PI.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703051


Locations
United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
GlycoMimetics Incorporated
Celerion
Investigators
Principal Investigator: Laura Sterling, MD Celerion

Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02703051     History of Changes
Other Study ID Numbers: GMI-1271-103
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs