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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlycoMimetics Incorporated
• Collaborator: Celerion
• Treatments: Lenograstim

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.