A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 19 - 60 |
| Updated: | 4/26/2017 |
| Start Date: | November 2015 |
| End Date: | August 2016 |
A Phase 1, Open-Label Study to Evaluate the Pharmacodynamics, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects
Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study
conducted at one study center in the United States (US).
conducted at one study center in the United States (US).
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.
We found this trial at
1
site
