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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT00448253
First received: March 14, 2007
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Symptoms of Inhalational Anthrax
Biological: NP-015
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics of Anthrax Immune Globulin Intravenous (Human), NP-015, in Healthy Volunteers.

Resource links provided by NLM:


Further study details as provided by Cangene Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Viral Markers for safety. [ Time Frame: screen, baseline, and Day(s)14 and 84 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Blood Chemistry [ Time Frame: screen, baseline, and D0 hours 0,1,2 and day(s) 1,3,7,14,28, and 84 ] [ Designated as safety issue: Yes ]
  • Urinalysis [ Time Frame: screen, baseline, and D0 hours 0 and day(s) 1,3,7,14,28, and 84 ] [ Designated as safety issue: Yes ]
  • Hematology (haptoglobin and free hemoglobin at baseline and day 1) [ Time Frame: screen, baseline, Day(s) 1,3,7,14,28, and 84 ] [ Designated as safety issue: Yes ]

Enrollment: 92
Study Start Date: July 2007
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA. And a Fourth Cohort at 840 units TNA with 2 additional product lots.
Biological: NP-015

Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA, or placebo.

And a Fourth Cohort at 840 units TNA with 2 additional product lots.

Other Name: Anthrax Immune Globulin (AIG)
Placebo Comparator: 2
Saline (equal volume to 210 U, 420 U, or 840 U TNA dose)
Biological: NP-015

Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA, or placebo.

And a Fourth Cohort at 840 units TNA with 2 additional product lots.

Other Name: Anthrax Immune Globulin (AIG)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female
  • Age 18/19 (dependent on local age of majority) - 55 years
  • Body mass index of 19 - 29
  • For female subjects that are not surgically sterilized, willingness to use an effective method of contraception throughout the trial including:
  • Using hormonal contraception (oral, injectable or implant) continuously for 3 months prior to the start of the trial and willing to continue to use hormonal contraception throughout the entire trial.
  • IUD inserted at least 3 months prior to dosing.
  • For female subjects who are postmenopausal < 2 years an FSH ≥ 40 mIU/mL must be obtained. If the FSH is < 40 mIU/mL the subject must agree to use an acceptable form of contraception (see above).
  • For males that have not had a vasectomy, willingness to use a condom with spermicide for the duration of the study. Also, male subjects must not donate sperm for the duration of the study.
  • Normal and healthy as determined by medical history, physical exam, ECG, vital signs and laboratory tests of liver, kidney and hematological functions
  • Written informed consent

Exclusion Criteria:

  • Heavy smokers (>10 cigarettes/day) or individuals using smokeless tobacco or nicotine containing products
  • Use of any investigational product within the past 30 days
  • Recipient of any blood product within the past 12 months
  • Plasma donation within 7 days or significant blood loss or blood donation within 56 days of baseline
  • Females with a hemoglobin level < 12 g/dL
  • Males with a hemoglobin level < 13 g/dL
  • History of hypersensitivity to blood products
  • History of allergy to latex or rubber
  • History of IgA deficiency
  • Pregnancy or lactation
  • Positive serology test for HIV or HCV, positive test for HBV as determined by HBsAg.
  • History of, or suspected substance abuse problem (including alcohol)
  • Failure of drug test at screening or baseline
  • Failure of alcohol test at baseline or consumption of alcoholic beverages within 48 hours of baseline
  • History of anthrax vaccination with AVA or any other anthrax vaccine
  • Individuals with planned medical procedures that will occur during the study
  • Use of prescription medications within 7 days prior to baseline, or anticipated use during the study (with the exception of hormonal contraceptives for females)
  • Use of over-the-counter, herbal medications or vitamins within 7 days of study admission
  • An opinion of the investigator that it would be unwise to allow participation of the subject in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448253

Locations
United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Cangene Corporation
Investigators
Principal Investigator: Alan S Marion, MD, PhD MDS Pharma Services
  More Information

No publications provided

Responsible Party: Fran Yadao, Manager Clinical Operations, Cangene Corp.
ClinicalTrials.gov Identifier: NCT00448253     History of Changes
Other Study ID Numbers: AX001
Study First Received: March 14, 2007
Last Updated: March 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cangene Corporation:
Inhalational Anthrax
Human Immune globulin

Additional relevant MeSH terms:
Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014