Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum - Full Text View

Sponsor:	Cangene Corporation
Collaborator:	Department of Health and Human Services
Information provided by:	Cangene Corporation
ClinicalTrials.gov Identifier:	NCT00448253

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 I

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:

MedlinePlus related topics: Anthrax

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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)

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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

Department of Health and Human Services

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 February 12, 2012