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

• Sponsor: GlycoMimetics Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02703051
• Collaborator: Celerion (Industry)
• Enrollment: 54
• Location: 1
• Arms: 3
• Actual Duration (Months): 9
• Patients Per Site Per Month: 6

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Nov 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Measurement of subsets of WBC [10 days]

Secondary Outcome Measures

1. Number of adverse events as a measure of safety and tolerability [19 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

• GlycoMimetics Incorporated
• Celerion

Investigators

• Principal Investigator: Laura Sterling, MD, Celerion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlycoMimetics Incorporated
• ClinicalTrials.gov Identifier: NCT02703051
• Other Study ID Numbers: GMI-1271-103
• First Posted: Mar 9, 2016
• Last Update Posted: Feb 27, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lenograstim

Study Results

No Results Posted as of Feb 27, 2018