Placebo-controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1271 in Healthy Volunteers
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
Sponsor: GlycoMimetics Incorporated
This PHASE1 trial investigates Healthy Adult Subjects and is currently completed. GlycoMimetics Incorporated leads this study, which shows 8 recorded versions since 2014 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
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Sep 2024 — Present [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
▶ Show 3 earlier versions
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Mar 2018 — Jun 2018 [monthly]
Completed PHASE1
-
Feb 2017 — Mar 2018 [monthly]
Completed PHASE1
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Jun 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- GlycoMimetics Incorporated
For direct contact, visit the study record on ClinicalTrials.gov .