Bacillus Anthracis (Anthrax)Phase 1NCT00138411
Monoclonal Antibody for Treatment of Inhalation Anthrax
A Phase 1 study testing Ciprofloxacin 500 mg and ETI-204 (Anthim) in people with Bacillus Anthracis (Anthrax), run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetics (how long a drug stays in the bloodstream and how high the levels of the drug are at different times) of ETI-204 following intravenous (IV-into a vein) injections, and to evaluate the effects that ETI-204 may have on the pharmacokinetics of oral… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacillus Anthracis (Anthrax)
- What is being tested?
- Ciprofloxacin 500 mg and ETI-204 (Anthim)
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Mar 2006
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects between the ages of 18-50 inclusive at the time of enrollment. In each of the drug cohorts (subgroups), at least two of the subjects must be female.
- The following screening laboratory parameters must be within the normal range: AST, ALT, alkaline phosphatase, hemoglobin, and serum creatinine. No repeat testing is allowed for these analytes. For any other clinical chemistry analyte or CBC (including differential and platelet count) parameter that is outside the normal range, the PI and the sponsor's medical monitor will confer and must agree in writing that the value has no clinical significance before the subject will be allowed to enter the study.
- The values for the following tests at screening are to be:
- G-6-P dehydrogenase - normal HBsAG - negative HBV - negative Anti-HCV - negative Anti-HIV (HIV antibody test) - negative Urine drug screen (including cotinine) - negative
- Female subjects of childbearing potential must agree to practice abstinence or to use a licensed, effective form of birth control (e.g., oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, intrauterine contraceptive device, Depo-Provera®, skin patch, vaginal ring, or cervical cap) for at least 30 days prior to enrollment and for the duration of the study, including the follow-up period. Females using hormonal contraceptives must agree to use at least one other method for at least 30 days prior to enrollment and for the duration of the study, including the follow-up period.
- Female subjects must have a negative pregnancy test.
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- No history of hospitalization for illness within the six months prior to study enrollment.
- Non-smoker or ex-smoker. If a subject is an ex-smoker, he/she must not have used nicotine for at least 6 months prior to enrollment. This will be confirmed by a negative urine test for cotinine.
- Able to spend the two days specified in the study schedule confined in a facility under study rules.
- Able to read, understand and sign the Informed Consent form.
Who cannot join
- Routine consumption of any medication (prescription or OTC), vitamin, mineral, antacid, or dietary supplement, for one week before and during the study. The sole exception are hormonal contraceptive agents, as detailed above, hormone replacement therapy, and thyroid replacement therapy. Subjects must be specifically reminded that antacids are excluded.
- Blood pressure greater than 145 mm Hg systolic and 95 mm Hg diastolic.
- Contraindication to the use of ciprofloxacin or any quinolone. (Part 2 only).
- Contraindication to the use of any monoclonal antibody.
- Medical condition that in the Investigator's opinion could adversely impact the subject's participation, safety or conduct of the study.
- Subject has taken an investigational medication in the previous three months.
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- The subject has a history of drug or alcohol abuse within the past two years.
- The subject is female and plans to become pregnant during the study or the 42 day follow-up period.
- Calculated Body Mass Index (BMI) greater than 35 or less than 18.5.
- The subject has been previously vaccinated with anthrax or has participated in clinical research involving anthrax.
- Any EKG abnormality except for the following:
- Sinus bradycardia in younger, athletic subjects
- Mild first degree A-V block (P-R interval < 0.23 sec)
- Mild right or left axis deviation
- Incomplete right bundle branch block DMID does not allow for exceptions of eligibility criteria waivers for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-Controlled, Double Blind, Dose-Escalation Phase I Study of the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Dose of ETI-204 [Anthim(TM)] and Its Potential Interaction With Ciprofloxacin
The purpose of this study is to evaluate the safety and pharmacokinetics (how long a drug stays in the bloodstream and how high the levels of the drug are at different times) of ETI-204 following intravenous (IV-into a vein) injections, and to evaluate the effects that ETI-204 may have on the pharmacokinetics of oral (by mouth) ciprofloxacin, an antibiotic approved by the U.S. Food and Drug Administration (FDA). ETI-204 is an experimental drug (not approved by the FDA) intended to protect against anthrax (a bacterial infection). Approximately 36 male and female healthy volunteers ages 18 to 50 will be in this study. Participation in this study may last up to eight weeks. Volunteers will have a single IV dose of the ETI-204 study drug or placebo (inactive substance, and some participants will also receive ciprofloxacin. They will stay in the Clinical Pharmacology Unit at least 36 hours after the dose.
Read the detailed description
This initial study with ETI-204 will examine the safety and pharmacokinetics of ETI-204 following IV administration both in the absence and presence of ciprofloxacin. The pharmacokinetics of ciprofloxacin in the presence of ETI-204 will also be determined. This study is a placebo-controlled, double-blind, randomized study which will be conducted at a single site. Healthy male and female volunteers will be recruited from the Columbus, OH area, and will have a maximum participation period of 7 months for each subject (from enrollment to end of follow-up period). The study population will roughly parallel the ethnicity of this geographic area. Because this is the first time that ETI-204 is studied in man, individuals under the age of 18 will not be permitted to participate in the study. Part 1 is a randomized, placebo-controlled, double-blind study being conducted at a single study site. Part 2 will be double-blind with respect to ETI-204 but not blinded for oral ciprofloxacin. Part 1 of the study is the dose escalation portion, in which the safety, tolerability, and pharmacokinetics of single IV doses of ETI-204 will be evaluated. Three dose levels are proposed for study: 18 mg, 54 mg, and 108 mg. At each dose level, 3 males and 3 females will be randomly assigned to active drug and 1 male and 1 female will be randomly assigned to placebo. Thus, at least 24 subjects will be studied in Part 1. Part 2 of the study will determine the safety, tolerability and pharmacokinetics of a single IV dose (108 mg dose from part 1, presuming no safety or tolerability issues), and whether or not there is an effect of ETI-204 on ciprofloxacin pharmacokinetics. There will be 2 groups of 6 subjects each. The first cohort will receive ETI-204 plus ciprofloxacin and the second will receive ETI-204 placebo plus ciprofloxacin. Together with the comparable group from part 1, this will allow the determination of the effects of ciprofloxacin on ETI-204 pharmacokinetics and of ETI-204 on ciprofloxacin pharmacokinetics. Subjects will receive ciprofloxacin 500 mg or placebo every 12 hours for a total of 14 days beginning at the time of ETI-204/placebo administration. It is anticipated that the number of subjects in part 1 of the study (18 receiving active ETI-204 and 6 receiving placebo) will be sufficient to allow a preliminary assessment of safety and efficacy (ETI-204 concentration). In part 2, 12 subjects will receive active ETI-204 (108 mg dose from part 1, presuming no safety or tolerability issues). Of these, 6 will also receive oral ciprofloxacin and 6 will serve as the controls (i.e., ETI-204 alone). An additional cohort of 6 subjects will receive ETI-204 placebo and oral ciprofloxacin. This number of subjects should be sufficient to provide an indication of the presence of a drug-drug interaction between ETI-204 and ciprofloxacin, but not necessarily the magnitude. All statistical comparisons will be performed using two sided tests at an alpha level of 0.05 unless specifically stated otherwise. All statistical null hypotheses assert that there are no differences between treatments. Because this is the first study in man with ETI-204, the full risks can not be determined. ETI-204 is being tested for its utility in preventing the life-threatening sequelae that may occur following exposure to anthrax. The results of this study could demonstrate that ETI-204 has an acceptable safety profile and that it has a pharmacokinetic profile that will provide for serum concentrations of the drug (antibody) over time that will be effective in preventing the toxicity of one of the exotoxins produced by B. anthracis.
- Conditions
- Bacillus Anthracis (Anthrax)
- Being tested
- Ciprofloxacin 500 mg, ETI-204 (Anthim)
- Keywords
- anthrax, Bacillus anthracis, monoclonal antibody, ETI-204
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin 500 mgDrug
ETI-204 (Anthim)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startOct 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacillus Anthracis (Anthrax)Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Single group
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138411
- Sponsor's protocol ID
- 04-096
- Other IDs
- AH-101
- Status last verified
- Jul 2006
- First submitted
- 26 Aug 2005
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Double Blind, Dose-Escalation Phase I Study of the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Dose of ETI-204 [Anthim(TM)] and Its Potential Interaction With Ciprofloxacin
- ClinicalTrials.gov ID
- NCT00138411
- Acronym / sponsor ID
- 04-096
- Conditions
- Bacillus Anthracis (Anthrax)
- Keywords
- anthrax, Bacillus anthracis, monoclonal antibody, ETI-204
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2005
- Study completion
- Mar 2006
- First posted
- 30 Aug 2005 (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 this study is to evaluate the safety and pharmacokinetics (how long a drug stays in the bloodstream and how high the levels of the drug are at different times) of ETI-204 following intravenous (IV-into a vein) injections, and to evaluate the effects that ETI-204 may have on the pharmacokinetics of oral (by mouth) ciprofloxacin, an antibiotic approved by the U.S. Food and Drug Administration (FDA). ETI-204 is an experimental drug (not approved by the FDA) intended to protect against anthrax (a bacterial infection). Approximately 36 male and female healthy volunteers ages 18 to 50 will be in this study. Participation in this study may last up to eight weeks. Volunteers will have a single IV dose of the ETI-204 study drug or placebo (inactive substance, and some participants will also receive ciprofloxacin. They will stay in the Clinical Pharmacology Unit at least 36 hours after the dose.
Detailed description
This initial study with ETI-204 will examine the safety and pharmacokinetics of ETI-204 following IV administration both in the absence and presence of ciprofloxacin. The pharmacokinetics of ciprofloxacin in the presence of ETI-204 will also be determined. This study is a placebo-controlled, double-blind, randomized study which will be conducted at a single site. Healthy male and female volunteers will be recruited from the Columbus, OH area, and will have a maximum participation period of 7 months for each subject (from enrollment to end of follow-up period). The study population will roughly parallel the ethnicity of this geographic area. Because this is the first time that ETI-204 is studied in man, individuals under the age of 18 will not be permitted to participate in the study. Part 1 is a randomized, placebo-controlled, double-blind study being conducted at a single study site. Part 2 will be double-blind with respect to ETI-204 but not blinded for oral ciprofloxacin. Part 1 of the study is the dose escalation portion, in which the safety, tolerability, and pharmacokinetics of single IV doses of ETI-204 will be evaluated. Three dose levels are proposed for study: 18 mg, 54 mg, and 108 mg. At each dose level, 3 males and 3 females will be randomly assigned to active drug and 1 male and 1 female will be randomly assigned to placebo. Thus, at least 24 subjects will be studied in Part 1. Part 2 of the study will determine the safety, tolerability and pharmacokinetics of a single IV dose (108 mg dose from part 1, presuming no safety or tolerability issues), and whether or not there is an effect of ETI-204 on ciprofloxacin pharmacokinetics. There will be 2 groups of 6 subjects each. The first cohort will receive ETI-204 plus ciprofloxacin and the second will receive ETI-204 placebo plus ciprofloxacin. Together with the comparable group from part 1, this will allow the determination of the effects of ciprofloxacin on ETI-204 pharmacokinetics and of ETI-204 on ciprofloxacin pharmacokinetics. Subjects will receive ciprofloxacin 500 mg or placebo every 12 hours for a total of 14 days beginning at the time of ETI-204/placebo administration. It is anticipated that the number of subjects in part 1 of the study (18 receiving active ETI-204 and 6 receiving placebo) will be sufficient to allow a preliminary assessment of safety and efficacy (ETI-204 concentration). In part 2, 12 subjects will receive active ETI-204 (108 mg dose from part 1, presuming no safety or tolerability issues). Of these, 6 will also receive oral ciprofloxacin and 6 will serve as the controls (i.e., ETI-204 alone). An additional cohort of 6 subjects will receive ETI-204 placebo and oral ciprofloxacin. This number of subjects should be sufficient to provide an indication of the presence of a drug-drug interaction between ETI-204 and ciprofloxacin, but not necessarily the magnitude. All statistical comparisons will be performed using two sided tests at an alpha level of 0.05 unless specifically stated otherwise. All statistical null hypotheses assert that there are no differences between treatments. Because this is the first study in man with ETI-204, the full risks can not be determined. ETI-204 is being tested for its utility in preventing the life-threatening sequelae that may occur following exposure to anthrax. The results of this study could demonstrate that ETI-204 has an acceptable safety profile and that it has a pharmacokinetic profile that will provide for serum concentrations of the drug (antibody) over time that will be effective in preventing the toxicity of one of the exotoxins produced by B. anthracis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male or female subjects between the ages of 18-50 inclusive at the time of enrollment. In each of the drug cohorts (subgroups), at least two of the subjects must be female.
- The following screening laboratory parameters must be within the normal range: AST, ALT, alkaline phosphatase, hemoglobin, and serum creatinine. No repeat testing is allowed for these analytes. For any other clinical chemistry analyte or CBC (including differential and platelet count) parameter that is outside the normal range, the PI and the sponsor's medical monitor will confer and must agree in writing that the value has no clinical significance before the subject will be allowed to enter the study.
- The values for the following tests at screening are to be:
- G-6-P dehydrogenase - normal HBsAG - negative HBV - negative Anti-HCV - negative Anti-HIV (HIV antibody test) - negative Urine drug screen (including cotinine) - negative
- Female subjects of childbearing potential must agree to practice abstinence or to use a licensed, effective form of birth control (e.g., oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, intrauterine contraceptive device, Depo-Provera®, skin patch, vaginal ring, or cervical cap) for at least 30 days prior to enrollment and for the duration of the study, including the follow-up period. Females using hormonal contraceptives must agree to use at least one other method for at least 30 days prior to enrollment and for the duration of the study, including the follow-up period.
Key exclusion criteria (15 listed)
- Routine consumption of any medication (prescription or OTC), vitamin, mineral, antacid, or dietary supplement, for one week before and during the study. The sole exception are hormonal contraceptive agents, as detailed above, hormone replacement therapy, and thyroid replacement therapy. Subjects must be specifically reminded that antacids are excluded.
- Blood pressure greater than 145 mm Hg systolic and 95 mm Hg diastolic.
- Contraindication to the use of ciprofloxacin or any quinolone. (Part 2 only).
- Contraindication to the use of any monoclonal antibody.
- Medical condition that in the Investigator's opinion could adversely impact the subject's participation, safety or conduct of the study.
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 |
|---|---|---|
| Ciprofloxacin 500 mg | Drug | – |
| ETI-204 (Anthim) | Drug | – |
Primary outcome
Not reported in the source record.
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 27 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ciprofloxacin 500 mg and ETI-204 (Anthim) in people with Bacillus Anthracis (Anthrax), run by National Institute of Allergy and Infectious Diseases (NIAID) 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 15 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 27 Aug 2010. 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. 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.
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 27 Aug 2010.