Inhalational AnthraxPhase 1NCT01932437
Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers
A Phase 1 study testing ETI-204 in people with Inhalational Anthrax, run by Elusys Therapeutics at 1 site in United States.
Trial summary
This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inhalational Anthrax
- What is being tested?
- ETI-204
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2013to 3 Jul 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females or males ≥18 years of age;
- All females regardless of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at Screening and Day -1;
- Females of childbearing potential (i.e., not postmenopausal or surgically sterile) must agree to practice abstinence or to use a medically accepted method of contraception from the time of Screening through 30 days after the final study visit. Acceptable methods of contraception include diaphragm/cervical cap with spermicide; sponge with spermicide; condom with spermicide; or intrauterine device with condom or spermicide. The following contraceptive methods are acceptable only when used with a condom and spermicide: birth control pills, birth control patches, vaginal ring, hormone under the skin, or hormone injections;
- Postmenopausal females, defined as females who have had amenorrhea for at least 12 months either naturally or following cessation of all exogenous hormonal treatments, and have a follicle stimulating hormone level of >40 mIU/mL at Screening;
- Females who have undergone surgical sterilization, including hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal ligation, or tubal essure;
- Males must agree to practice abstinence or use a condom with spermicide and to refrain from sperm donation from Screening during the study and for 30 days after the final study visit;
- Provide written informed consent;
- Willing to comply with study restrictions.
Who cannot join
- Body weight >100 kg;
- Body mass index ≥32 kg/m2;
- Pregnant or lactating female;
- Clinically significant comorbidity that would interfere with completion of the study procedures or objectives, or compromise the subject's safety;
- Supine systolic blood pressure (BP) ≥150 mmHg or ≤90 mmHg or diastolic BP ≥95 mmHg;
- Use of H1 receptor antagonists (i.e., antihistamines) within 5 days prior to Day 1;
Show all 32Show fewer
- Evidence of drug or alcohol abuse within 6 months of Day 1 as determined by the Investigator;
- Positive test result for drugs of abuse (with the exception of medically prescribed drugs) at Screening or on Day -1;
- Positive test for alcohol at Screening, subject to Investigator's discretion. Subjects who test positive for alcohol at Day -1 are excluded from the study;
- Treatment with an investigational agent within 30 days or 5 half-lives of the investigational agent at Day 1 (whichever is longer);
- Congenital or acquired immunodeficiency syndrome;
- Prior solid organ or bone marrow transplant;
- Positive test for Hepatitis B (surface antigen), Hepatitis C, or human immunodeficiency virus (HIV) at Screening;
- History of prior treatment for anthrax exposure or prior anthrax infection;
- Prior immunization with any approved or investigational anthrax vaccine or prior treatment with an investigational anthrax treatment (e.g., ETI-204, raxibacumab, or anthrax immune globulin);
- Military personnel deployed in 1990 or after, unless the subject can provide documentation demonstrating he or she has not previously received any approved or investigational anthrax vaccine;
- Use of systemic steroids, immunosuppressive agents, anticoagulants, or anti-arrhythmics within 1 year prior to Day 1. A single short course (i.e., less than 14 days) of systemic steroid therapy is allowed, provided it concluded more than 6 months prior to Day 1;
- Donation or loss of >500 mL of blood within 30 days or plasma within 7 days of Day 1;
- Prior stroke, epilepsy, relapsing or degenerative central nervous system disease, or relapsing or degenerative ocular disease;
- Myocardial infarction or acute coronary syndrome in the past 5 years, active angina pectoris, or heart failure (New York Heart Association scale >1);
- History of chronic liver disease;
- Calculated creatinine clearance of <30 mL/min using the Cockcroft-Gault equation;
- Any clinically significant abnormality, in the Investigator's opinion, on electrocardiogram (ECG) or clinical laboratory tests (hematology, clinical chemistry, or urinalysis) at Screening. Out of range tests may be repeated to confirm;
- History of allergic or hypersensitivity reaction or hives to other therapeutic antibodies or immunoglobulins;
- History of any malignant neoplasm within the last 5 years, with the exception of adequately treated localized or in situ non-melanoma carcinoma of the skin (e.g., basal cell carcinoma) or the cervix;
- Subjects who, in the opinion of the Investigator, are not suitable candidates for enrollment or who may not comply with the requirements of the study.
- Platelet count <140 K/µL;
- Prothrombin time/international normalized ratio or activated partial thromboplastin time >1.2 X the upper limit of normal at Screening or Day -1;
- Poor muscle mass as determined by the Investigator;
- Family or personal history of a bleeding disorder;
- History of unexplained bleeding;
- Use of any anticoagulant or anti-platelet drug for 3 months prior to Screening. At the discretion of the Investigator, daily aspirin may be taken for general health reasons.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Dallas, Texas, 75247
About this study
Official title: A Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular Doses of ETI-204 in Adult Volunteers
This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers
Read the detailed description
Following completion of a Screening visit subjects will arrive at the clinic on Day -1. On Day 1, subjects will be randomized in a 3:1 ratio to receive an IM dose of either ETI-204 or matching placebo, respectively:
Cohort 1: 4 subjects randomized to 4 mg/kg ETI-204 or matching placebo Cohort 2: 8 subjects randomized to 8 mg/kg ETI-204 or matching placebo Cohort 3: 8 subjects randomized to 16 mg/kg ETI-204 or matching placebo Cohort 4: 8 subjects randomized to 20 mg/kg ETI-204 or matching placebo Cohort 5: 8 subjects randomized to 24 mg/kg ETI-204 or matching placebo
Study drug will be injected bilaterally into the vastus lateralis muscles, with the subject in a supine position. A separate syringe with a 21-gauge,1.5-inch needle will be used for each injection. The number of injections and injection volume will increase with increasing dose allowing for an assessment of increasing IM ETI-204 doses and the tolerability of a larger number of injections and larger injection volume.
Subjects will be pretreated with 50 mg oral diphenhydramine approximately 30 minutes prior to administration of study drug.
Subjects will be discharged from the study facility on Day 4 following completion of study assessments and will return to the study facility for additional visits on Days 7, 10, 15 (±3 days), 29 (±3 days), 43 (±3 days), and 71 (±4 days).
Decisions to dose-escalate will be made by the investigator(s) in conjunction with the sponsor and will be based solely on the available safety and local tolerability data up to and including Day 4.
- Conditions
- Inhalational Anthrax
- Being tested
- ETI-204, Placebo
- Keywords
- Monoclonal antibody, ETI-204, IM, safety, PK, immunogenicity
- Medical subject headings
- Inhalation anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETI-204Biological
Also called Obiltoxaximab
monoclonal antibody
PlaceboOther
Placebo for ETI-204
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 3 subjects will receive an IM dose of 4 mg/kg ETI-204, administered as two injections with a maximum volume of 2 mL at each injection site.
1 subject will receive an IM dose of ETI-204-placebo in an identical fashion. Receives: Biological: ETI-204; Other: Placebo |
| Cohort 2 | Experimental | 6 subjects will receive an IM dose of 8 mg/kg ETI-204, administered as two injections with a maximum volume of 4 mL at each injection site.
2 subjects will receive an IM dose of ETI-204-placebo in an identical fashion. Receives: Biological: ETI-204; Other: Placebo |
| Cohort 3 | Experimental | 6 subjects will receive an IM dose of 16 mg/kg ETI-204, administered at four sites, with administration of 4 mL at one site and the remaining volume given in three additional injections with a maximum volume of 4 mL at each injection site.
2 subjects will receive an IM dose of ETI-204-placebo in an identical fashion. Receives: Biological: ETI-204; Other: Placebo |
| Cohort 4 | Experimental | 6 subjects will receive an IM dose of 20 mg/kg ETI-204, administered at up to five sites, with the injection volume distributed equally between injections and a maximum volume of 4 mL per injection site.
2 subjects will receive an IM dose of ETI-204-placebo in an identical fashion. Receives: Biological: ETI-204; Other: Placebo |
| Cohort 5 | Experimental | 6 subjects will receive an IM dose of 24 mg/kg ETI-204, administered at up to six sites, with administration of 5 mL at one site and the remaining volume given in up to five additional injections distributed equally with a maximum volume of 4 mL per injection site.
2 subjects will receive an IM dose of ETI-204-placebo in an identical fashion. Receives: Biological: ETI-204; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Adverse Events
Safety was assessed for all subjects in the Safety Population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical examinations, injection site assessments, skin assessments for presence/absence of rash, and adverse events (AEs).
Measured: Up to 71 (+/- 4) days or for 30 additional days after the final study visit for subjects with ongoing adverse events at the final scheduled study visit, for each group.
Secondary outcomes (7)
Maximum Observed Plasma Concentration of ETI-204 (Cmax)
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Measured: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax)
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Measured: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Area Under the Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Measured: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf)
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Measured: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Half-life (t1/2)
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Measured: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Apparent Clearance (CL/F)
Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.
Measured: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Number of Participants With Anti-ETI-204 Antibodies
Blood samples were collected and serum samples were assayed at an initial dilution of 1:10. Samples that were positive at the 1:10 dilution were serially diluted 1:2 and assayed until a negative result was attained. The titer of the most dilute sample yielding a positive result was recorded as the titer for that time point. Immunogenicity was measured by the number of participants in each study arm with anti-ETI-204 antibody values at Days 8, 43 or 71 ≥ 4-times higher than at baseline, or if the titer was negative at baseline, the post-treatment sample(s) required a titer of at least 1:20 for it to be considered positive.
Measured: Pre-dose and on Days 10, 43, and 71 after the IM injection of ETI-204 or placebo on Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study start26 Jul 2013
- Primary completion3 Jul 2014
- Study completion3 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elusys Therapeutics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex King, MD, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932437
- Sponsor's protocol ID
- AH106
- Status last verified
- Apr 2019
- First submitted
- 2 Aug 2013
- Last updated
- 6 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular Doses of ETI-204 in Adult Volunteers
- ClinicalTrials.gov ID
- NCT01932437
- Acronym / sponsor ID
- AH106
- Conditions
- Inhalational Anthrax
- Keywords
- Monoclonal antibody, ETI-204, IM, safety, PK, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Elusys TherapeuticsUniversity, hospital or other
- Study start
- 26 Jul 2013 (actual)
- Primary completion
- 3 Jul 2014 (actual)
- Study completion
- 3 Jul 2014 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Posted 1 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers
Detailed description
Following completion of a Screening visit subjects will arrive at the clinic on Day -1. On Day 1, subjects will be randomized in a 3:1 ratio to receive an IM dose of either ETI-204 or matching placebo, respectively:
Cohort 1: 4 subjects randomized to 4 mg/kg ETI-204 or matching placebo Cohort 2: 8 subjects randomized to 8 mg/kg ETI-204 or matching placebo Cohort 3: 8 subjects randomized to 16 mg/kg ETI-204 or matching placebo Cohort 4: 8 subjects randomized to 20 mg/kg ETI-204 or matching placebo Cohort 5: 8 subjects randomized to 24 mg/kg ETI-204 or matching placebo
Study drug will be injected bilaterally into the vastus lateralis muscles, with the subject in a supine position. A separate syringe with a 21-gauge,1.5-inch needle will be used for each injection. The number of injections and injection volume will increase with increasing dose allowing for an assessment of increasing IM ETI-204 doses and the tolerability of a larger number of injections and larger injection volume.
Subjects will be pretreated with 50 mg oral diphenhydramine approximately 30 minutes prior to administration of study drug.
Subjects will be discharged from the study facility on Day 4 following completion of study assessments and will return to the study facility for additional visits on Days 7, 10, 15 (±3 days), 29 (±3 days), 43 (±3 days), and 71 (±4 days).
Decisions to dose-escalate will be made by the investigator(s) in conjunction with the sponsor and will be based solely on the available safety and local tolerability data up to and including Day 4.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: ETI-204, Other: Placebo3 subjects will receive an IM dose of 4 mg/kg ETI-204, administered as two injections with a maximum volume of 2 mL at each injection site. 1 subject will receive an IM dose of ETI-204-placebo in an identical fashion. |
| Cohort 2 | Experimental | Biological: ETI-204, Other: Placebo6 subjects will receive an IM dose of 8 mg/kg ETI-204, administered as two injections with a maximum volume of 4 mL at each injection site. 2 subjects will receive an IM dose of ETI-204-placebo in an identical fashion. |
| Cohort 3 | Experimental | Biological: ETI-204, Other: Placebo6 subjects will receive an IM dose of 16 mg/kg ETI-204, administered at four sites, with administration of 4 mL at one site and the remaining volume given in three additional injections with a maximum volume of 4 mL at each injection site. 2 subjects will receive an IM dose of ETI-204-placebo in an identical fashion. |
| Cohort 4 | Experimental | Biological: ETI-204, Other: Placebo6 subjects will receive an IM dose of 20 mg/kg ETI-204, administered at up to five sites, with the injection volume distributed equally between injections and a maximum volume of 4 mL per injection site. 2 subjects will receive an IM dose of ETI-204-placebo in an identical fashion. |
| Cohort 5 | Experimental | Biological: ETI-204, Other: Placebo6 subjects will receive an IM dose of 24 mg/kg ETI-204, administered at up to six sites, with administration of 5 mL at one site and the remaining volume given in up to five additional injections distributed equally with a maximum volume of 4 mL per injection site. 2 subjects will receive an IM dose of ETI-204-placebo in an identical fashion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females or males ≥18 years of age;
- All females regardless of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at Screening and Day -1;
- Females of childbearing potential (i.e., not postmenopausal or surgically sterile) must agree to practice abstinence or to use a medically accepted method of contraception from the time of Screening through 30 days after the final study visit. Acceptable methods of contraception include diaphragm/cervical cap with spermicide; sponge with spermicide; condom with spermicide; or intrauterine device with condom or spermicide. The following contraceptive methods are acceptable only when used with a condom and spermicide: birth control pills, birth control patches, vaginal ring, hormone under the skin, or hormone injections;
- Postmenopausal females, defined as females who have had amenorrhea for at least 12 months either naturally or following cessation of all exogenous hormonal treatments, and have a follicle stimulating hormone level of >40 mIU/mL at Screening;
- Females who have undergone surgical sterilization, including hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal ligation, or tubal essure;
Key exclusion criteria (32 listed)
- Body weight >100 kg;
- Body mass index ≥32 kg/m2;
- Pregnant or lactating female;
- Clinically significant comorbidity that would interfere with completion of the study procedures or objectives, or compromise the subject's safety;
- Supine systolic blood pressure (BP) ≥150 mmHg or ≤90 mmHg or diastolic BP ≥95 mmHg;
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-204Also: Obiltoxaximabmonoclonal antibody | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboPlacebo for ETI-204 | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Number of Participants Who Experienced Adverse Events
Time frame: Up to 71 (+/- 4) days or for 30 additional days after the final study visit for subjects with ongoing adverse events at the final scheduled study visit, for each group.
Safety was assessed for all subjects in the Safety Population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical examinations, injection site assessments, skin assessments for presence/absence of rash, and adverse events (AEs).
7 secondary outcomes
Maximum Observed Plasma Concentration of ETI-204 (Cmax)
Time frame: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax)
Time frame: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Area Under the Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)
Time frame: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf)
Time frame: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Half-life (t1/2)
Time frame: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Apparent Clearance (CL/F)
Time frame: Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.
Number of Participants With Anti-ETI-204 Antibodies
Time frame: Pre-dose and on Days 10, 43, and 71 after the IM injection of ETI-204 or placebo on Day 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alex King, MD principal investigator
Covance Clinical Research Unit
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 in people with Inhalational Anthrax, 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 8 inclusion and 32 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 6 May 2019. 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?
Yes. Results are posted in the registry (first posted 1 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experienced Adverse Events (time frame: Up to 71 (+/- 4) days or for 30 additional days after the final study visit for subjects with ongoing adverse events at the final scheduled study visit, for each group.). 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 6 May 2019.