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

NCT02703051 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-02-27

No results posted yet for this study

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).

Conditions

  • Healthy Volunteers

Interventions

DRUG

GMI-1271

DRUG

Filgrastim

DRUG

Placebo Injection

DRUG

Placebo Infusion

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • GlycoMimetics Incorporated

    lead INDUSTRY

Principal Investigators

  • Laura Sterling, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-08-31
Completion
2016-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02703051 on ClinicalTrials.gov