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

• Sponsor: GlycoMimetics Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02931214
• Collaborator: Celerion (Industry)
• Enrollment: 58
• Location: 1
• Arms: 2
• Actual Duration (Months): 27
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: GMI-1359; Drug: Placebo	Phase 1

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

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GMI-1359 Dose escalation	Drug: GMI-1359
Experimental: Placebo Dose escalation	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Treatment related adverse events [15 days]

   Treatment related adverse events as a measure of safety and tolerability of GMI-1359

Secondary Outcome Measures

1. Pharmacokinetics [48 hours]

   Cmax (peak plasma concentration)

2. Pharmacokinetics [48 hours]

   AUC (area under the curve)

3. Pharmacokinetics [48 hours]

   Tmax (time to peak plasma concentration)

4. Pharmacodynamics [48 hours]

   CD34 cell measurement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

• GlycoMimetics Incorporated
• Celerion

Investigators

• Principal Investigator: Laura Sterling, MD, Celerion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlycoMimetics Incorporated
• ClinicalTrials.gov Identifier: NCT02931214
• Other Study ID Numbers: GMI-1359-101
• First Posted: Oct 12, 2016
• Last Update Posted: Mar 4, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GlycoMimetics Incorporated: Healthy Subjects; Pharmacokinetics; Pharmacodynamics

Study Results

No Results Posted as of Mar 4, 2019