Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT02168595
Status:
COMPLETED
Last Update Posted:
2018-02-27
First Post:
2014-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placebo-controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1271 in Healthy Volunteers
Sponsor:
GlycoMimetics Incorporated
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Intravenous Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of single ascending IV doses of GMI-1271 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 (US). One (1) cohort of 12 subjects (6 active and 6 placebo) and two (2) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. Subjects will participate in only one cohort. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and PK assessment of GMI-1271.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: