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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: GMI-1271; Drug: Placebo Infusion; Drug: Placebo Injection; Drug: Filgrastim

• Registration Number: NCT02703051
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-09
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-23
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Filgrastim	Placebo Infusion	Filgrastim
GMI-1271	Placebo Injection	GMI-1271
GMI-1271 with Filgrastim	GMI-1271	GMI-1271 with Filgrastim
GMI-1271	GMI-1271	GMI-1271
GMI-1271 with Filgrastim	Filgrastim	GMI-1271 with Filgrastim
Filgrastim	Filgrastim	Filgrastim

Primary Outcome Measures

Name	Time	Method
Measurement of subsets of WBC	10 days

Secondary Outcome Measures

Name	Time	Method
Number of adverse events as a measure of safety and tolerability	19 days

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States