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

GlycoMimetics Incorporated27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

RivipanselDRUG

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).

PlaceboDRUG

Matched Placebo administered as single dose subcutaneously with rHuPH20.

RivipanselDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Clinical Research Unit

Brussels, Belgium

Outcomes

Primary Outcomes

Assessment of adverse events (AEs)

Time frame: Baseline up to 7 days of dosing

Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG)

Time frame: Baseline up to 7 days of dosing

Assessment of vital signs (including blood pressure and pulse rate)

Time frame: Baseline up to 7 days of dosing

Assessment of clinical laboratory tests

Time frame: Baseline up to 7 days of dosing

Secondary Outcomes

Maximum Observed Plasma Concentration (Cmax) for rivipansel following single dose

Time frame: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration

Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following single dose

Time frame: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for rivipansel following single dose

Time frame: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rivipansel following single dose

Time frame: Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration

Dose-Normalized Cmax for rivipansel following single dose

Data from ClinicalTrials.gov

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