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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703051
• Other study ID #: GMI-1271-103
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2016
• Last updated: February 23, 2018
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2018
• Source: GlycoMimetics Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GMI-1271

• Filgrastim

• Placebo Injection

• Placebo Infusion

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
GlycoMimetics Incorporated	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of subsets of WBC		10 days
Secondary	Number of adverse events as a measure of safety and tolerability		19 days