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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02931214

Enrollment

Registered

2016-10-12

Start date

2016-08-31

Completion date

2018-11-30

Last updated

2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Subjects, Pharmacokinetics, Pharmacodynamics

Brief summary

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.

Interventions

DRUGGMI-1359

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy adult male or females, 19-60 years of age (inclusive). 2. Medically healthy with no clinically significant screening results. 3. Females of childbearing potential must either be sexually inactive (abstinent) for 3 months prior to dosing or be using an acceptable birth control method 4. Females must have a negative pregnancy test at the time of screening and prior to dosing for inclusion in the study. 5. Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol.

Exclusion criteria

1. Subject is mentally or legally incapacitated. 2. 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. 3. Normal clinical laboratory values. 4. Normal heart rate and blood pressure. 5. Blood donation or significant blood loss within 56 days prior to dosing. 6. Plasma donation within 7 days prior to dosing. 7. Participation in another clinical trial within 28 days prior to dosing.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Pharmacokinetics	48 hours	Cmax (peak plasma concentration)
Pharmacodynamics	48 hours	CD34 cell measurement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026