Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: GMI-1359
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GMI-1359<br>Dose escalation | Drug: GMI-1359<br> <br> |
| Experimental: Placebo<br>Dose escalation | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related adverse events | Treatment related adverse events as a measure of safety and tolerability of GMI-1359 | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Cmax (peak plasma concentration) | 48 hours | 
| Pharmacokinetics | AUC (area under the curve) | 48 hours | 
| Pharmacokinetics | Tmax (time to peak plasma concentration) | 48 hours | 
| Pharmacodynamics | CD34 cell measurement | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Subjects, Pharmacokinetics, Pharmacodynamics