Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects
Lead Sponsor:
GlycoMimetics Incorporated
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 sub...
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index 17.5 - 30.5 kg/m2 and body weight \>50 kg at Screening.
- Normal skin without potentially obscuring features in the area intended for infusion.
- Subjects willing to defer receiving prophylactic immunizations (eg, influenza or pneumococcal vaccines) during the study.
- Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- History of a recent major surgery (within 3 months of screening).
- Serious infection within 1 month of screening.
- Subjects with chronic skin condition that may interfere in the assessment of emergent safety data.
- A positive urine drug screen.
- Known sensitivity to hyaluronidases.
- History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibodies (HCV).
- Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02217917
Start Date
October 1 2015
End Date
April 1 2016
Last Update
June 18 2020
Active Locations (1)
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1
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070