Healthy VolunteersPhase 1NCT00829582
Intravenous Dose-Escalation Study With ETI-204 in Adult Volunteers
A Phase 1 study testing ETI-204, "Anthim" in people with Healthy Volunteers, run by Elusys Therapeutics at 1 site in United States.
Trial summary
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 (AnthimTM) Population: This study will determine the safety, tolerability and pharmacokinetics of a single iv dose of ETI-204 in subjects 18 to 50… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ETI-204, "Anthim"
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2009
- 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 three of the subjects must be female.
- The following screening laboratory parameters must be within 5% of the normal range: CBC (excluding WBC) and coagulation tests (aPTT, PT and INR). Absolute counts of WBC must be within 10% of the normal range. BUN, creatinine, and total and direct bilirubin may be up to 10% above the upper limits of normal. AST, ALT and alkaline phosphatase must be within normal limits. Urinalysis must be within generally accepted normal limits.
- The values for the following tests at screening are to be:
- G-6-P dehydrogenase - normal HBsAg - negative HBV - negative (except immunized subjects may have positive anti-HBs) Anti-HCV - negative Anti-HIV (HIV antibody test) - negative Urine drug screen (including cotinine) - negative
- Female subjects must agree to practice heterosexual 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.
- Nonsmoker 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. Exceptions may be made for sporadic users with negative urine cotinine tests; this will be determined on a case-by-case basis.
- 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, or dietary supplement, for one week before and during the study. The sole exceptions are hormonal contraceptive agents, as detailed above. The withdrawal time for any prescription medication should be no less than 1 week prior to the beginning of the study.
- Blood pressure greater than 139 mm Hg systolic and 89 mm Hg diastolic. Repeat measurements are allowed.
- Contraindication to the use of any monoclonal antibody: history of allergic reactions to any biologic or formulation component
- 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.
- The subject has a history of drug or alcohol abuse within the past two years.
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- The subject is female and plans to become pregnant during the whole study period or 6 months.
- Calculated Body Mass Index (BMI) greater than 35.0 or less than 18.5.
- The subject has been previously vaccinated with anthrax or has participated in clinical research involving anthrax.
- Any ECG abnormality except for the following:
- Sinus bradycardia, no lower than 46 beats per minute in younger, athletic subjects
- Sinus tachycardia if the heart rate is within normal limits when vital signs are measured
- Respiratory arrhythmia
- Mild first degree A-V block (P-R interval < 0.23 sec)
- Incomplete right bundle branch block
- Left anterior hemiblock
- Ectopic atrial focus
- Premature atrial contractions
- Unifocal premature ventricular contractions
- Mild right or left axis deviation
- Indeterminate axis
- J-point elevation
Trial locations and contacts
1 site in 1 country.
United States1 site
Osu, 5084 Graves 333 W Tenth Ave
Columbus, Ohio, 43210
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 (AnthimTM) [Elusys Protocol Number AH-102]
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 (AnthimTM)
Population: This study will determine the safety, tolerability and pharmacokinetics of a single iv dose of ETI-204 in subjects 18 to 50 years of age. Three cohorts will be studied sequentially: subjects receiving 120 mg, 240 mg and 360 mg of ETI-204. The study will be randomized, double-blind, and stratified by gender. Each cohort will contain 15 subjects (including at least four females), twelve who will receive ETI-204 and three who will receive placebo.
Study Objectives: To determine the safety, tolerability and pharmacokinetics of ETI-204 following a single intravenous administration.
Read the detailed description
Study Duration: Maximum 70 days for each subject (from enrollment to end of follow-up period), unless the Day 70 HAHA (human anti-humanized antibodies) is positive, in which case subjects will be followed until HAHA test results are negative. This does not represent the total study duration, which is determined by the screening period and enrollment rate.
Description of Agent: ETI-204 is a monoclonal antibody (MAb) to protective antigen (PA) from Bacillus anthracis.
Schedule of Evaluations: Blood for pharmacokinetics (antibody concentration): Predose and at the following times after the start of infusion: 60 minutes (i.e., at the completion of the infusion), 3, 6, 12, 24 and 48 hours and on Days 7, 14, 21, 42, 56 and 70.
Blood chemistry, hematology, and urinalysis (referred to as safety laboratory assessments in the schedule of events), and urine drug screen (including ethanol and cotinine at all visits): Screening, Day 0, immediately pre-dose and on the following days after the start of infusion: 7, 14, 21, and 42. Urine pregnancy tests for all females will be performed at screening, baseline, immediately pre-dose and at 42 days. Tests of coagulation and viral serology tests will be done at screening only.
ECG: A 12-lead ECG will be done at screening. In subjects with acceptable ECG parameters, continuous 24-h Holter monitoring. will be then performed. After enrollment, a standard 12-lead ECG recording will be performed on study Day 1 (predose, 1.5h, 2h, 4h, 8h and 12h ±20 min) and continuous ECG telemetry monitoring beginning approximately 2 hours prior to the start of infusion and continuing at least 14 hours after the start of infusion. ECG is also recorded at the following study Days: 2, 7, 14, 21, and 42.
Measurement of product specific human anti-humanized antibodies (HAHA): Pre-dose and 42 days after dosing. HAHA positive subjects on Day 42 will be followed bi-weekly until study Day 70 and then monthly until HAHA test results are negative.
Vital signs (BP, P, T, RR): Screening, Day 0, before and at the following times after the start of the infusion on study day 1: 15, 30, 45, 60, 90±3 minutes; 2h,4h,8h, 12h and 24h±10 minutes (Day 2); Days 7, 14, 21 and 42.
Screening for Local and Systemic Adverse Events: The infusion site and proximal areas will be inspected for evidence of erythema, edema, visible or palpable cord, etc. on study days 1, 2, 7, 14, 21 and 42.
Participating Sites: The Ohio State University Clinical Pharmacology Unit Columbus, Ohio
- Conditions
- Healthy Volunteers
- Being tested
- ETI-204, "Anthim", placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETI-204, "Anthim"Drug
single intravenous infusion of 120, 240 or 360 mg of ETI-204
placeboOther
single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ETI-204 | Experimental | ETI-204, Anthim Receives: Drug: ETI-204, "Anthim" |
| placebo | Sham comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinical safety following the infusion
Measured: 42 days
Secondary outcomes (1)
immunogenicity
Measured: 42-70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elusys Therapeutics
- Sponsor type
- University, hospital or other
- Investigators
- Glen Apseloff, MD, Principal investigator, OSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829582
- Sponsor's protocol ID
- AH-102
- Status last verified
- Jan 2010
- First submitted
- 26 Jan 2009
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nagy CF, Leach TS, Hoffman JH, Czech A, Carpenter SE, Guttendorf R. Pharmacokinetics and Tolerability of Obiltoxaximab: A Report of 5 Healthy Volunteer Studies. Clin Ther. 2016 Sep;38(9):2083-2097.e7. doi: 10.1016/j.clinthera.2016.07.170. Epub 2016 Aug 24.
PubMed 27568215
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. 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 (AnthimTM) [Elusys Protocol Number AH-102]
- ClinicalTrials.gov ID
- NCT00829582
- Acronym / sponsor ID
- AH-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Elusys TherapeuticsUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Jan 2009 (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.
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 (AnthimTM)
Population: This study will determine the safety, tolerability and pharmacokinetics of a single iv dose of ETI-204 in subjects 18 to 50 years of age. Three cohorts will be studied sequentially: subjects receiving 120 mg, 240 mg and 360 mg of ETI-204. The study will be randomized, double-blind, and stratified by gender. Each cohort will contain 15 subjects (including at least four females), twelve who will receive ETI-204 and three who will receive placebo.
Study Objectives: To determine the safety, tolerability and pharmacokinetics of ETI-204 following a single intravenous administration.
Detailed description
Study Duration: Maximum 70 days for each subject (from enrollment to end of follow-up period), unless the Day 70 HAHA (human anti-humanized antibodies) is positive, in which case subjects will be followed until HAHA test results are negative. This does not represent the total study duration, which is determined by the screening period and enrollment rate.
Description of Agent: ETI-204 is a monoclonal antibody (MAb) to protective antigen (PA) from Bacillus anthracis.
Schedule of Evaluations: Blood for pharmacokinetics (antibody concentration): Predose and at the following times after the start of infusion: 60 minutes (i.e., at the completion of the infusion), 3, 6, 12, 24 and 48 hours and on Days 7, 14, 21, 42, 56 and 70.
Blood chemistry, hematology, and urinalysis (referred to as safety laboratory assessments in the schedule of events), and urine drug screen (including ethanol and cotinine at all visits): Screening, Day 0, immediately pre-dose and on the following days after the start of infusion: 7, 14, 21, and 42. Urine pregnancy tests for all females will be performed at screening, baseline, immediately pre-dose and at 42 days. Tests of coagulation and viral serology tests will be done at screening only.
ECG: A 12-lead ECG will be done at screening. In subjects with acceptable ECG parameters, continuous 24-h Holter monitoring. will be then performed. After enrollment, a standard 12-lead ECG recording will be performed on study Day 1 (predose, 1.5h, 2h, 4h, 8h and 12h ±20 min) and continuous ECG telemetry monitoring beginning approximately 2 hours prior to the start of infusion and continuing at least 14 hours after the start of infusion. ECG is also recorded at the following study Days: 2, 7, 14, 21, and 42.
Measurement of product specific human anti-humanized antibodies (HAHA): Pre-dose and 42 days after dosing. HAHA positive subjects on Day 42 will be followed bi-weekly until study Day 70 and then monthly until HAHA test results are negative.
Vital signs (BP, P, T, RR): Screening, Day 0, before and at the following times after the start of the infusion on study day 1: 15, 30, 45, 60, 90±3 minutes; 2h,4h,8h, 12h and 24h±10 minutes (Day 2); Days 7, 14, 21 and 42.
Screening for Local and Systemic Adverse Events: The infusion site and proximal areas will be inspected for evidence of erythema, edema, visible or palpable cord, etc. on study days 1, 2, 7, 14, 21 and 42.
Participating Sites: The Ohio State University Clinical Pharmacology Unit Columbus, Ohio
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETI-204 | Experimental | Drug: ETI-204, "Anthim"ETI-204, Anthim |
| placebo | Sham comparator | Other: placebo |
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 three of the subjects must be female.
- The following screening laboratory parameters must be within 5% of the normal range: CBC (excluding WBC) and coagulation tests (aPTT, PT and INR). Absolute counts of WBC must be within 10% of the normal range. BUN, creatinine, and total and direct bilirubin may be up to 10% above the upper limits of normal. AST, ALT and alkaline phosphatase must be within normal limits. Urinalysis must be within generally accepted normal limits.
- The values for the following tests at screening are to be:
- G-6-P dehydrogenase - normal HBsAg - negative HBV - negative (except immunized subjects may have positive anti-HBs) Anti-HCV - negative Anti-HIV (HIV antibody test) - negative Urine drug screen (including cotinine) - negative
- Female subjects must agree to practice heterosexual 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 (22 listed)
- Routine consumption of any medication (prescription or OTC), vitamin, mineral, or dietary supplement, for one week before and during the study. The sole exceptions are hormonal contraceptive agents, as detailed above. The withdrawal time for any prescription medication should be no less than 1 week prior to the beginning of the study.
- Blood pressure greater than 139 mm Hg systolic and 89 mm Hg diastolic. Repeat measurements are allowed.
- Contraindication to the use of any monoclonal antibody: history of allergic reactions to any biologic or formulation component
- 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.
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 |
|---|---|---|
| ETI-204, "Anthim"single intravenous infusion of 120, 240 or 360 mg of ETI-204 | Drug | ETI-204 |
| placebosingle intravenous infusion | Other | placebo |
Primary outcome
Evidence of clinical safety following the infusion
Time frame: 42 days
1 secondary outcome
immunogenicity
Time frame: 42-70 days
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 14 Nov 2017.
- Derived from this study: PubMed 27568215Nagy CF, Leach TS, Hoffman JH, Czech A, Carpenter SE, Guttendorf R. Pharmacokinetics and Tolerability of Obiltoxaximab: A Report of 5 Healthy Volunteer Studies. Clin Ther. 2016 Sep;38(9):2083-2097.e7. doi: 10.1016/j.clinthera.2016.07.170. Epub 2016 Aug 24.
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Screening Protocol
Pain
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.
Glen Apseloff, MD principal investigator
OSU
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 ETI-204, "Anthim" in people with Healthy Volunteers, run by Elusys Therapeutics 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 22 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 14 Nov 2017. 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?
Evidence of clinical safety following the infusion (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00829582, which also lists 1 linked publication.
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 14 Nov 2017.