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

16 czerwca 2020 zaktualizowane przez: GlycoMimetics Incorporated

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single And Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Rivipansel (pf 06460031) Following Subcutaneous Administration With Rhuph20 (pf 06744547) In Healthy Subjects

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.

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

27

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Brussels, Belgia, B-1070
        • Pfizer Clinical Research Unit

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 55 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Cohort 1
Single ascending dose in 3 period cross-over design (with optional 4th period)
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).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
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).
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).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Eksperymentalny: Cohort 2
Multiple ascending dose
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).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
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).
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).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
Eksperymentalny: Cohort 3
Multiple ascending dose
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).
Matched Placebo administered as single dose subcutaneously with rHuPH20.
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).
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).
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Assessment of adverse events (AEs)
Ramy czasowe: Baseline up to 7 days of dosing
Baseline up to 7 days of dosing
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG)
Ramy czasowe: Baseline up to 7 days of dosing
Baseline up to 7 days of dosing
Assessment of vital signs (including blood pressure and pulse rate)
Ramy czasowe: Baseline up to 7 days of dosing
Baseline up to 7 days of dosing
Assessment of clinical laboratory tests
Ramy czasowe: Baseline up to 7 days of dosing
Baseline up to 7 days of dosing

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Maximum Observed Plasma Concentration (Cmax) for rivipansel following single dose
Ramy czasowe: 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
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
Ramy czasowe: 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
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
Ramy czasowe: 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
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
Ramy czasowe: 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
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
Ramy czasowe: 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
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 AUClast for rivipansel
Ramy czasowe: 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
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 AUCinf for rivipansel
Ramy czasowe: 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
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
Plasma Decay Half-Life (t1/2) for rivipansel following single dose
Ramy czasowe: 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
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
Apparent Clearance (CL/F) for rivipansel following single dose
Ramy czasowe: 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
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
Apparent Volume of Distribution (Vz/F) for rivipansel following single dose
Ramy czasowe: 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
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
Maximum Observed Plasma Concentration (Cmax) for rivipansel following multiple dose
Ramy czasowe: Days 1, 7
Days 1, 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following multiple dose
Ramy czasowe: Days 1, 7
Days 1, 7
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for rivipansel following multiple dose administration, where tau is 12 hours
Ramy czasowe: Days 1, 7
Days 1, 7
Dose-Normalized Cmax for rivipansel following multiple dose administration
Ramy czasowe: Days 1, 7
Days 1, 7
Dose-Normalized AUCtau for rivipansel following multiple dose administration
Ramy czasowe: Days 1, 7
Days 1, 7
Plasma Decay Half-Life (t1/2) for rivipansel following multiple dose
Ramy czasowe: Day 7
Day 7
Minimum Observed Plasma Concentration (Cmin) for rivipansel following multiple dose
Ramy czasowe: Day 7
Day 7
Apparent Clearance (CL/F) for rivipansel following multiple dose
Ramy czasowe: Day 7
Day 7
Peak to Trough Ratio (PTR) of plasma concentration for rivipanselmultiple dose administration
Ramy czasowe: Day 7
Day 7
Accumulation ratio for Area Under the Curve during the dosing interval (Rac) for rivipansel
Ramy czasowe: Day 7
Day 7

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 2015

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2016

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2016

Daty rejestracji na studia

Pierwszy przesłany

13 sierpnia 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 sierpnia 2014

Pierwszy wysłany (Oszacować)

15 sierpnia 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 czerwca 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 czerwca 2020

Ostatnia weryfikacja

1 czerwca 2020

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • B5201007
  • 2014-002748-41 (Numer EudraCT)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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