HealthyPhase 1NCT02931214
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers
A Phase 1 study testing GMI-1359 in people with Healthy, run by GlycoMimetics Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GMI-1359
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Nov 2018
- 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 or females, 19-60 years of age (inclusive).
- Medically healthy with no clinically significant screening results.
- Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
- Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study.
- Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol.
Who cannot join
- Subject is mentally or legally incapacitated.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
- Normal clinical laboratory values.
- Normal heart rate and blood pressure.
- Blood donation or significant blood loss within 56 days prior to dosing.
- Plasma donation within 7 days prior to dosing.
- Participation in another clinical trial within 28 days prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GMI-1359 in Healthy Adult Subjects
The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of GMI-1359.
- Conditions
- Healthy
- Being tested
- GMI-1359, Placebo
- Keywords
- Healthy Subjects, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMI-1359Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| GMI-1359 | Experimental | Dose escalation Receives: Drug: GMI-1359 |
| Placebo | Experimental | Dose escalation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related adverse events
Treatment related adverse events as a measure of safety and tolerability of GMI-1359
Measured: 15 days
Secondary outcomes (4)
Pharmacokinetics
Cmax (peak plasma concentration)
Measured: 48 hours
Pharmacokinetics
AUC (area under the curve)
Measured: 48 hours
Pharmacokinetics
Tmax (time to peak plasma concentration)
Measured: 48 hours
Pharmacodynamics
CD34 cell measurement
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 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
- NCT02931214
- Sponsor's protocol ID
- GMI-1359-101
- Status last verified
- Mar 2019
- First submitted
- 6 Sep 2016
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GMI-1359 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02931214
- Acronym / sponsor ID
- GMI-1359-101
- Conditions
- Healthy
- Keywords
- Healthy Subjects, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 12 Oct 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.
The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects.
Detailed description
This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of GMI-1359.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GMI-1359 | Experimental | Drug: GMI-1359Dose escalation |
| Placebo | Experimental | Drug: PlaceboDose escalation |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult male or females, 19-60 years of age (inclusive).
- Medically healthy with no clinically significant screening results.
- Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method
- Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study.
- Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol.
Key exclusion criteria (7 listed)
- Subject is mentally or legally incapacitated.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study.
- Normal clinical laboratory values.
- Normal heart rate and blood pressure.
- Blood donation or significant blood loss within 56 days prior to dosing.
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-1359 | Drug | GMI-1359 |
| Placebo | Drug | Placebo |
Primary outcome
Treatment related adverse events
Time frame: 15 days
Treatment related adverse events as a measure of safety and tolerability of GMI-1359
4 secondary outcomes
Pharmacokinetics
Time frame: 48 hours
Pharmacokinetics
Time frame: 48 hours
Pharmacokinetics
Time frame: 48 hours
Pharmacodynamics
Time frame: 48 hours
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 4 Mar 2019.
- Individual participant dataSharing planned: No
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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-1359 in people with Healthy, 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 5 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 4 Mar 2019. 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?
Treatment related adverse events (time frame: 15 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 4 Mar 2019.