Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum
This study has been completed.
Sponsor:
Cangene Corporation
Collaborator:
Information provided by:
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT00448253
First received: March 14, 2007
Last updated: March 25, 2011
Last verified: March 2011
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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 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 June 17, 2013