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

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Healthy
Interventions
DRUG

Rivipansel

Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel). The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).

DRUG

Placebo

Matched Placebo administered as single dose subcutaneously with rHuPH20.

DRUG

Rivipansel

Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).

DRUG

Rivipansel

Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).

DRUG

Placebo

Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.

Trial Locations (1)

B-1070

Pfizer Clinical Research Unit, Brussels

All Listed Sponsors
lead

GlycoMimetics Incorporated

INDUSTRY

NCT02217917 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects | Biotech Hunter | Biotech Hunter