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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Respiratory Tract Infections
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Infection
Respiratory Tract Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014