Healthy VolunteersPhase 1NCT02703051
A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects
A Phase 1 study testing GMI-1271 and Filgrastim in people with Healthy Volunteers, run by GlycoMimetics Incorporated at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GMI-1271 and Filgrastim
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- GMI-1271, Filgrastim, Placebo Injection, Placebo Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMI-1271Drug
FilgrastimDrug
Placebo InjectionDrug
Placebo InfusionDrug
| Study group | Role | What they receive |
|---|---|---|
| GMI-1271 | Experimental | GMI-1271 Receives: Drug: GMI-1271; Drug: Placebo Injection |
| Filgrastim | Active comparator | Filgrastim Receives: Drug: Filgrastim; Drug: Placebo Infusion |
| GMI-1271 with Filgrastim | Experimental | GMI-1271 with Filgrastim Receives: Drug: GMI-1271; Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of subsets of WBC
Measured: 10 days
Secondary outcomes (1)
Number of adverse events as a measure of safety and tolerability
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoMimetics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Laura Sterling, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703051
- Sponsor's protocol ID
- GMI-1271-103
- Status last verified
- Feb 2018
- First submitted
- 3 Mar 2016
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02703051
- Acronym / sponsor ID
- GMI-1271-103
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GMI-1271 | Experimental | Drug: GMI-1271, Drug: Placebo InjectionGMI-1271 |
| Filgrastim | Active comparator | Drug: Filgrastim, Drug: Placebo InfusionFilgrastim |
| GMI-1271 with Filgrastim | Experimental | Drug: GMI-1271, Drug: FilgrastimGMI-1271 with Filgrastim |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMI-1271 | Drug | GMI-1271, GMI-1271 with Filgrastim |
| Filgrastim | Drug | Filgrastim, GMI-1271 with Filgrastim |
| Placebo Injection | Drug | GMI-1271 |
| Placebo Infusion | Drug | Filgrastim |
Primary outcome
Measurement of subsets of WBC
Time frame: 10 days
1 secondary outcome
Number of adverse events as a measure of safety and tolerability
Time frame: 19 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Sterling, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GMI-1271 and Filgrastim in people with Healthy Volunteers, run by GlycoMimetics Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of subsets of WBC (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.