A Phase 1 interventional study of ETI-204 and Placebo in Inhalational Anthrax, sponsored by Elusys Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-06.
Sponsored by Elusys Therapeutics · Phase 1, Interventional, and Other
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
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.
Elusys Therapeutics is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: ETI-204 · Other: Placebo
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.
Biological: ETI-204 · Other: Placebo
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.
Biological: ETI-204 · Other: Placebo
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.
Biological: ETI-204 · Other: Placebo
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.
Biological: ETI-204 · Other: Placebo
monoclonal antibody
Also known as: Obiltoxaximab
Placebo for ETI-204
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).
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.
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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
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.
Time frame: Pre-dose and on Days 10, 43, and 71 after the IM injection of ETI-204 or placebo on Day 1.
Study started July 26, 2013. Study completed July 03, 2014. Conducted at a Phase 1 Clinical Research Unit
| Milestone | Placebo | ETI-204 4 mg/kg | ETI-204 8 mg/kg | ETI-204 16 mg/kg | ETI-204 20 mg/kg | ETI-204 24 mg/kg |
|---|---|---|---|---|---|---|
| Started | 1 | 3 | 0 | 0 | 0 | 0 |
| Completed | 1 | 3 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo | ETI-204 4 mg/kg | ETI-204 8 mg/kg | ETI-204 16 mg/kg | ETI-204 20 mg/kg | ETI-204 24 mg/kg |
|---|---|---|---|---|---|---|
| Started | 2 | 0 | 6 | 0 | 0 | 0 |
| Completed | 2 | 0 | 6 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo | ETI-204 4 mg/kg | ETI-204 8 mg/kg | ETI-204 16 mg/kg | ETI-204 20 mg/kg | ETI-204 24 mg/kg |
|---|---|---|---|---|---|---|
| Started | 2 | 0 | 0 | 6 | 0 | 0 |
| Completed | 2 | 0 | 0 | 6 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo | ETI-204 4 mg/kg | ETI-204 8 mg/kg | ETI-204 16 mg/kg | ETI-204 20 mg/kg | ETI-204 24 mg/kg |
|---|---|---|---|---|---|---|
| Started | 2 | 0 | 0 | 0 | 6 | 0 |
| Completed | 2 | 0 | 0 | 0 | 6 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Placebo | ETI-204 4 mg/kg | ETI-204 8 mg/kg | ETI-204 16 mg/kg | ETI-204 20 mg/kg | ETI-204 24 mg/kg |
|---|---|---|---|---|---|---|
| Started | 2 | 0 | 0 | 0 | 0 | 6 |
| Completed | 2 | 0 | 0 | 0 | 0 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
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).
| Participants | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|---|
| Number of Participants Who Experienced Adverse Events | 5 | 3 | 1 | 1 | 2 | 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.
| µg/mL | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration of ETI-204 (Cmax) | 24.9 ± 4.70 | 54.8 ± 6.45 | 105 ± 22.5 | 118 ± 28.2 | 154 ± 32.4 |
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.
| days | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|
| Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax) | 9.00 (3.00 to 9.00) | 9.00 (3.00 to 9.00) | 6.00 (6.00 to 14.00) | 6.00 (6.00 to 14.00) | 6.00 (3.00 to 9.00) |
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.
| µg.day/mL | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) | 774 ± 92.3 | 1540 ± 328 | 2890 ± 578 | 3660 ± 945 | 3740 ± 570 |
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.
| µg.day/mL | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) | 819 ± 85.9 | 1580 ± 441 | 3200 ± 755 | 4220 ± 1360 | 3960 ± 823 |
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.
| days | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|
| Half-life (t1/2) | 16.0 ± 1.60 | 20.2 ± 8.47 | 19.6 ± 4.10 | 23.3 ± 6.17 | 20.0 ± 7.20 |
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.
| Liters/day | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|
| Apparent Clearance (CL/F) | 0.410 ± 0.0545 | 0.415 ± 0.117 | 0.445 ± 0.113 | 0.382 ± 0.0736 | 0.478 ± 0.202 |
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.
| Participants | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|---|
| Number of Participants With Anti-ETI-204 Antibodies | 0 | 0 | 0 | 0 | 0 | 0 |
Collected over Up to 71 (+/- 4) days or for 30 additional days after the final scheduled study visit for subjects with ongoing adverse events at that visit, for each group.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/9 (0%) | 0/9 (0%) | 5/9 (55.6%) |
| Cohort 1 | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort 2 | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Cohort 3 | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Cohort 4 | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Cohort 5 | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Event | Placebo | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|---|
| Injection site painGeneral disorders | 2/9 | 1/3 | 0/6 | 1/6 | 0/6 | 0/6 |
| Menstruation IrregularReproductive system and breast disorders | 0/9 | 1/3 | 0/6 | 0/6 | 0/6 | 0/6 |
| Oropharyngeal PainRespiratory, thoracic and mediastinal disorders | 0/9 | 1/3 | 0/6 | 0/6 | 0/6 | 0/6 |
| PruritusSkin and subcutaneous tissue disorders | 0/9 | 1/3 | 0/6 | 0/6 | 0/6 | 0/6 |
| RashSkin and subcutaneous tissue disorders | 0/9 | 1/3 | 0/6 | 0/6 | 0/6 | 0/6 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/9 | 1/3 | 0/6 | 0/6 | 0/6 | 0/6 |
| DizzinessNervous system disorders | 0/9 | 0/3 | 0/6 | 0/6 | 1/6 | 1/6 |
| VomitingGastrointestinal disorders | 0/9 | 0/3 | 1/6 | 0/6 | 0/6 | 1/6 |
| Back painMusculoskeletal and connective tissue disorders | 0/9 | 0/3 | 0/6 | 0/6 | 1/6 | 0/6 |
| ConstipationGastrointestinal disorders | 0/9 | 0/3 | 0/6 | 0/6 | 1/6 | 0/6 |
| Age, Continuous(years) | Placebo | ETI-204 | Total |
|---|---|---|---|
| Mean | 45.8 ± 11.53 | 47.4 ± 14.31 | 47.0 ± 13.5 |
| Sex: Female, Male(Participants) | Placebo | ETI-204 | Total |
|---|---|---|---|
| Female | 6 | 11 | 17 |
| Male | 3 | 16 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | ETI-204 | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 5 | 7 |
| Not Hispanic or Latino | 7 | 21 | 28 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Placebo | ETI-204 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 13 | 17 |
| White | 5 | 12 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Body weight(kg) | Placebo | ETI-204 | Total |
|---|---|---|---|
| Mean | 67.71 ± 13.406 | 76.33 ± 12.351 | 74.2 ± 12.989 |
| Height(cm) | Placebo | ETI-204 | Total |
|---|---|---|---|
| Mean | 164.18 ± 8.859 | 171.01 ± 8.062 | 169.3 ± 8.672 |
| BMI(kg/m2) | Placebo | ETI-204 | Total |
|---|---|---|---|
| Mean | 24.92 ± 2.983 | 26.04 ± 3.454 | 25.76 ± 3.337 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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