Clinical Trial: Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety and Pharmacokinetics of Anthrax Immune Globulin Intravenous (Human), NP-015, in Healthy Volunteers.

Brief Summary: The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and laboratory assessments. To determine the dose proportionality relation of three different doses of NP-015.

Detailed Summary:

  • The test product is Anthrax Immune Globulin Intravenous (Human), NP-015.
  • The product is supplied as a sterile liquid suitable for IV administration.
  • Product potency is expressed in units of anthrax toxin neutralization assays(TNA) per vial.
  • This study is a phase 1, placebo controlled, dose-ranging study in healthy volunteers. Subjects will receive one of three NP-015 doses (210, 420 or 840 units TNA) or equal volumes of saline placebo.
  • Enrolment will be sequential, starting at the lowest NP-015 dose with accrual into the next higher dose after all patients at the lower dose have been treated.
  • The first 3 Cohorts: The Subjects will be recruited in cohorts of 24, with placebo controls included in each dosing group. In each cohort, subjects will be randomized to receive either NP-015 (N = 18/dosing group) or placebo (N = 6/dosing group). For Cohort 4: 20 Subjects will be recruited and dosed at the highest dose with 2 additional product lots (10 subjects per lot).

Plasma samples will be drawn over 84 days. Plasma will be tested for anti-anthrax antibodies by a protective antigen (anti-PA) ELISA and toxin neutralization assay (TNA).

  • Serological testing for HIV, HBV and HCV will be conducted at screening to determine eligibility. Nucleic acid amplification testing (NAT) and serological testing for HIV, HBV and HCV will be conducted at baseline (day -1) and at the final visit (day 84 or early withdrawal). NAT for parvovirus B19 will be conducted at baseline (day -1), day 14, and the final visit (day 84 or early withdrawal).
  • Safety data will be collected
    Sponsor: Cangene Corporation

    Current Primary Outcome: Anti-PA antibody and TNA for PK analyses. [ Time Frame: screen, baseline, and D0 hours 1,3,8 and day(s) 1,3,5,7,9,11,14,21,28,42,56 and 84 ]

    Original Primary Outcome: Anti-PA antibody and TNA at hours 1,3,8 and day(s) 1,3,7,14,28 and 84 for PK analyses.

    Current Secondary Outcome:

    • Viral Markers for safety. [ Time Frame: screen, baseline, and Day(s)14 and 84 ]
    • Dose proportionality analyses. [ Time Frame: screen, baseline, and D0 hours 1,3,8 and day(s) 1,3,5,7,9,11,14,21,28,42,56 and 84 ]
    • Blood Chemistry [ Time Frame: screen, baseline, and D0 hours 0,1,2 and day(s) 1,3,7,14,28, and 84 ]
    • Urinalysis [ Time Frame: screen, baseline, and D0 hours 0 and day(s) 1,3,7,14,28, and 84 ]
    • Hematology (haptoglobin and free hemoglobin at baseline and day 1) [ Time Frame: screen, baseline, Day(s) 1,3,7,14,28, and 84 ]


    Original Secondary Outcome:

    • Hematology, Blood Chemistry (haptoglobin and free hemoglobin), Urinalysis, and
    • Viral Markers for safety.
    • Dose proportionality analyses.


    Information By: Cangene Corporation

    Dates:
    Date Received: March 14, 2007
    Date Started: July 2007
    Date Completion:
    Last Updated: March 25, 2011
    Last Verified: March 2011