Symptoms of Inhalational AnthraxPhase 1NCT00448253
Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum
A Phase 1 study testing NP-015 in people with Symptoms of Inhalational Anthrax, run by Emergent BioSolutions at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptoms of Inhalational Anthrax
- What is being tested?
- NP-015
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Pharmacokinetics of Anthrax Immune Globulin Intravenous (Human), NP-015, in Healthy Volunteers.
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.
Read the 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 assays(TNA) 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 = 18/dosing group) or placebo (N = 6/dosing 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-1/2, 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.
- Conditions
- Symptoms of Inhalational Anthrax
- Being tested
- NP-015
- Keywords
- Inhalational Anthrax, Human Immune globulin
- Medical subject headings
- Inhalation anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP-015Biological
Also called Anthrax Immune Globulin (AIG)
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Biological: NP-015 |
| 2 | Placebo comparator | Saline (equal volume to 210 U, 420 U, or 840 U TNA dose) Receives: Biological: NP-015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-PA antibody and TNA for PK analyses.
Measured: screen, baseline, and D0 hours 1,3,8 and day(s) 1,3,5,7,9,11,14,21,28,42,56 and 84
Secondary outcomes (5)
Viral Markers for safety.
Measured: screen, baseline, and Day(s)14 and 84
Dose proportionality analyses.
Measured: screen, baseline, and D0 hours 1,3,8 and day(s) 1,3,5,7,9,11,14,21,28,42,56 and 84
Blood Chemistry
Measured: screen, baseline, and D0 hours 0,1,2 and day(s) 1,3,7,14,28, and 84
Urinalysis
Measured: screen, baseline, and D0 hours 0 and day(s) 1,3,7,14,28, and 84
Hematology (haptoglobin and free hemoglobin at baseline and day 1)
Measured: screen, baseline, Day(s) 1,3,7,14,28, and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms of Inhalational AnthraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Alan S Marion, MD, PhD, Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448253
- Sponsor's protocol ID
- AX001
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2007
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Anthrax Immune Globulin Intravenous (Human), NP-015, in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00448253
- Acronym / sponsor ID
- AX001
- Conditions
- Symptoms of Inhalational Anthrax
- Keywords
- Inhalational Anthrax, Human Immune globulin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 16 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 assays(TNA) 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 = 18/dosing group) or placebo (N = 6/dosing 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-1/2, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: NP-015Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA. And a Fourth Cohort at 840 units TNA with 2 additional product lots. |
| 2 | Placebo comparator | Biological: NP-015Saline (equal volume to 210 U, 420 U, or 840 U TNA dose) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP-015Also: Anthrax Immune Globulin (AIG)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. | Biological | 1, 2 |
Primary outcome
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
5 secondary outcomes
Viral Markers for safety.
Time frame: screen, baseline, and Day(s)14 and 84
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
Blood Chemistry
Time frame: screen, baseline, and D0 hours 0,1,2 and day(s) 1,3,7,14,28, and 84
Urinalysis
Time frame: screen, baseline, and D0 hours 0 and day(s) 1,3,7,14,28, and 84
Hematology (haptoglobin and free hemoglobin at baseline and day 1)
Time frame: screen, baseline, Day(s) 1,3,7,14,28, and 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan S Marion, MD, PhD principal investigator
MDS Pharma Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NP-015 in people with Symptoms of Inhalational Anthrax, run by Emergent BioSolutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.