drugset
drugset / Trial / NCT02217917

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects

NCT02217917 ↗

Phase 1 Completed 27 enrolled GlycoMimetics Incorporated
RandomizedSequentialDouble-blindBasic science

Summary

This is a 2 part study designed to provide an initial assessment on the safety, tolerability, and PK of rivipansel, following single ascending (Part 1) and multiple ascending dosing (Part 2) given subcutaneously with rHuPH20, in healthy subjects. Part 1 of the study will be conducted using a cross-over design while Part 2 of the study will be conducted using a parallel design.

Timeline

Start
2015-10
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivipansel Small molecule 350 mg Subcutaneous
Subject Rivipansel Small molecule 700 mg Subcutaneous
Subject Rivipansel Small molecule 1210 mg Subcutaneous
Subject Rivipansel Small molecule 1400 mg Subcutaneous
Subject Rivipansel Small molecule 4200 mg Subcutaneous
Background rHuPH20 Protein / enzyme biologic — Subcutaneous

Indications

No indication recorded.