NCT02703051

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2015

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

March 3, 2016

Last Update Submit

February 23, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Measurement of subsets of WBC

    10 days

Secondary Outcomes (1)

  • Number of adverse events as a measure of safety and tolerability

    19 days

Study Arms (3)

GMI-1271

EXPERIMENTAL

GMI-1271

Drug: GMI-1271Drug: Placebo Injection

Filgrastim

ACTIVE COMPARATOR

Filgrastim

Drug: FilgrastimDrug: Placebo Infusion

GMI-1271 with Filgrastim

EXPERIMENTAL

GMI-1271 with Filgrastim

Drug: GMI-1271Drug: Filgrastim

Interventions

GMI-1271DRUG
GMI-1271GMI-1271 with Filgrastim
FilgrastimDRUG
FilgrastimGMI-1271 with Filgrastim
Placebo InjectionDRUG
GMI-1271
Placebo InfusionDRUG
Filgrastim

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult male and/or females, 19 to 60 years of age, inclusive.
  • Medically healthy with no clinically significant screening results as deemed by the PI.

You may not qualify if:

  • History of presence of clinically significant medical condition or disease in the opinion of the PI.
  • Alcoholism or drug abuse.
  • Liver disease.
  • Female subjects who are pregnant or lactating.
  • Known history or evidence of active hepatitis A, B, or C or HIV.
  • Clinically significant cardiovascular disease.
  • Participation in another clinical trial within 28 days prior to the first dose of GMI-1271 or filgrastim, whichever occurs first.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

uproleselanFilgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Laura Sterling, MD

    Celerion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 9, 2016

Study Start

November 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

US(1)