Healthy Volunteers
Conditions
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).
Interventions
Sponsors
Celerion
GlycoMimetics Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of subsets of WBC | 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events as a measure of safety and tolerability | 19 days |
Countries
United States
Outcome results
None listed