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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: GMI-1359

• Registration Number: NCT02931214
• Lead Sponsor: GlycoMimetics Incorporated

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Primary Completion: 2017-10
• Study Completion: 2018-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Dose escalation
GMI-1359	GMI-1359	Dose escalation

Primary Outcome Measures

Name	Time	Method
Treatment related adverse events	15 days	Treatment related adverse events as a measure of safety and tolerability of GMI-1359

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	48 hours	Tmax (time to peak plasma concentration)
Pharmacodynamics	48 hours	CD34 cell measurement

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States