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

NCT ID: NCT02217917

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-04-30

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 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

Single ascending dose in 3 period cross-over design (with optional 4th period)

Group Type: EXPERIMENTAL

Rivipansel

Intervention Type: DRUG

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).

Placebo

Intervention Type: DRUG

Matched Placebo administered as single dose subcutaneously with rHuPH20.

Cohort 2

Multiple ascending dose

Group Type: EXPERIMENTAL

Rivipansel

Intervention Type: DRUG

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).

Placebo

Intervention Type: DRUG

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

Cohort 3

Multiple ascending dose

Group Type: EXPERIMENTAL

Rivipansel

Intervention Type: DRUG

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).

Placebo

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: DRUG

Placebo

Matched Placebo administered as single dose subcutaneously with rHuPH20.

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlycoMimetics Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Clinical Research Unit

Brussels, , Belgium

Countries

Belgium

Other Identifiers

2014-002748-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B5201007

Identifier Type: -

Identifier Source: org_study_id