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

GlycoMimetics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo Injection; Drug: GMI-1271; Drug: Filgrastim; Drug: Placebo Infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02703051

GMI-1271-103

Details and patient eligibility

About

Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).

Enrollment: 54 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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54 participants in 3 patient groups

GMI-1271

Experimental group

Description:

GMI-1271

Treatment:

Drug: GMI-1271

Drug: Placebo Injection

Filgrastim

Active Comparator group

Description:

Filgrastim

Treatment:

Drug: Filgrastim

Drug: Placebo Infusion

GMI-1271 with Filgrastim

Experimental group

Description:

GMI-1271 with Filgrastim

Treatment:

Drug: Filgrastim

Drug: GMI-1271