Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448253
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2007-03-14
Brief Title:
Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum
Sponsor:
Emergent BioSolutions
Organization:
Emergent BioSolutions
Study Overview
Official Title:
Safety and Pharmacokinetics of Anthrax Immune Globulin Intravenous Human NP-015 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 assaysTNA 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 18dosing group or placebo N 6dosing 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 throughout the 84-day study
Screening within 28 days prior to Baseline
Informed consent
Review of admission criteria
Medical history general physical examination vital signs electrocardiogram and concomitant medications will be recorded
Hematology blood chemistry urinalysis viral serology anti-HIV-12 Anti-HCV HBsAg anti-HBc
Serum pregnancy test for all female subjects
Drug screen urine
Blood collection for anti-PA antibody and toxin neutralization assay TNA assessment
Baseline Day -1 within 24 hours prior to Day 0
Review of admission criteria
Assessment of brief physical exam vital signs weight hematology blood chemistry urinalysis and concomitant medications
Assessment of haptoglobin and free hemoglobin levels
Update of medical history
NAT testing for HIV HBV HCV and parvovirus B19 and serological testing for HIV HBV and HCV
Serum pregnancy test for all female subjects
Alcohol urine and drug screen urine
Blood collection for baseline anti-PA antibody and TNA assessment
Subjects will be required to stay overnight following their baseline assessment
NP-015 Administration day 0
Following baseline assessment NP-015 will be administered intravenously
Urinalysis will be performed at the end of the infusion period appearance and color specific gravity protein glucose pH occult blood ketones microscopic examination
Assessments following the completion of NP-015 administration 1 3 and 8 hrs days 1 3 5 7 9 11 14 21 28 42 56 and 84 or early withdrawal
Following NP-015 administration blood will be collected for anti-PA antibody ELISA analysis and TNA assessment at each of the respective times
Assessment of vital signs adverse events and concomitant medications
Additional Assessments
Days 1 3 7 14 28 and 84 or early withdrawal Assessment of hematology blood chemistry and urinalysis
Day 1 Assessment of haptoglobin and free hemoglobin levels
Day 14 NAT for parvovirus B19
Day 28 serum pregnancy test for female subjects
Final day 84 or early withdrawal visit a general physical exam serum pregnancy test for female subjects and viral marker testing NAT for HBV HCV HIV and parvovirus B19 and serology for HIV HBV and HCV will be performed
For Cohort 4 there will be no anti anthrax antibody testing and the subjects will be assessed for safety only up to day 28
The product is supplied as a sterile liquid suitable for IV administration
Product potency is expressed in units of anthrax toxin neutralization assaysTNA 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 18dosing group or placebo N 6dosing 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 throughout the 84-day study
Screening within 28 days prior to Baseline
Informed consent
Review of admission criteria
Medical history general physical examination vital signs electrocardiogram and concomitant medications will be recorded
Hematology blood chemistry urinalysis viral serology anti-HIV-12 Anti-HCV HBsAg anti-HBc
Serum pregnancy test for all female subjects
Drug screen urine
Blood collection for anti-PA antibody and toxin neutralization assay TNA assessment
Baseline Day -1 within 24 hours prior to Day 0
Review of admission criteria
Assessment of brief physical exam vital signs weight hematology blood chemistry urinalysis and concomitant medications
Assessment of haptoglobin and free hemoglobin levels
Update of medical history
NAT testing for HIV HBV HCV and parvovirus B19 and serological testing for HIV HBV and HCV
Serum pregnancy test for all female subjects
Alcohol urine and drug screen urine
Blood collection for baseline anti-PA antibody and TNA assessment
Subjects will be required to stay overnight following their baseline assessment
NP-015 Administration day 0
Following baseline assessment NP-015 will be administered intravenously
Urinalysis will be performed at the end of the infusion period appearance and color specific gravity protein glucose pH occult blood ketones microscopic examination
Assessments following the completion of NP-015 administration 1 3 and 8 hrs days 1 3 5 7 9 11 14 21 28 42 56 and 84 or early withdrawal
Following NP-015 administration blood will be collected for anti-PA antibody ELISA analysis and TNA assessment at each of the respective times
Assessment of vital signs adverse events and concomitant medications
Additional Assessments
Days 1 3 7 14 28 and 84 or early withdrawal Assessment of hematology blood chemistry and urinalysis
Day 1 Assessment of haptoglobin and free hemoglobin levels
Day 14 NAT for parvovirus B19
Day 28 serum pregnancy test for female subjects
Final day 84 or early withdrawal visit a general physical exam serum pregnancy test for female subjects and viral marker testing NAT for HBV HCV HIV and parvovirus B19 and serology for HIV HBV and HCV will be performed
For Cohort 4 there will be no anti anthrax antibody testing and the subjects will be assessed for safety only up to day 28
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None