Trial · NCT01929226
Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers
NCT01929226, Phase 1, Completed, Elusys Therapeutics; results first posted 2019-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers. Trials, record NCT01929226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01929226
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers
- NCT number
- NCT01929226
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 280 participants, actual
- Lead sponsor
- Elusys Therapeutics
- Conditions
- Inhalational Anthrax
- Interventions
- ETI-204, Placebo
- First posted
- 2013-08-27
- Last updated
- 2019-04-08
- Results first posted
- 2019-04-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced Adverse Events | Up to 71 days or 101 days (30 days after the final study visit) for subjects with ongoing adverse events at the final 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, skin assessments, infusion site assessments, and adverse events. |
| Secondary | Maximum Observed Plasma Concentration of ETI-204 (Cmax) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL. |
| Secondary | Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL. |
| Secondary | Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL. |
| Secondary | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL. |
| Secondary | Terminal Half-life (t1/2) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL. |
| Secondary | Systemic Clearance (CL) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL. |
| Secondary | Volume of Distribution (Vd) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL. |
| Secondary | Volume of Distribution at Steady State (Vss) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL. |
| Secondary | Number of Participants With Anti-ETI-204 Antibodies | On Day 1 prior to the start of infusion and on Days 8, 43, and 71. | Serum anti-ETI-204 antibody titers were determined for all subjects in the safety population. 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 post-treatment ≥ 4-times higher than baseline at Day 8, 43 or 71, 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced Adverse Events | Up to 71 days or 101 days (30 days after the final study visit) for subjects with ongoing adverse events at the final study visit, for each group. | All randomized participants who received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Plasma Concentration of ETI-204 (Cmax) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Of the 210 participants who received ETI-204, 202 were included in the PK population. One was excluded due to missing dosing record and 7 received partial doses of ETI-204 (6 discontinued study drug due to an AE and one received a partial dose because of mechanical issues with the infusion pump). | µg/mL | MEAN |
| SECONDARY | Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Of the 210 participants who received ETI-204, 202 were included in the PK population. One was excluded due to missing dosing record and 7 received partial doses of ETI-204 (6 discontinued study drug due to an AE and one received a partial dose because of mechanical issues with the infusion pump). | days | MEDIAN |
| SECONDARY | Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | Of the 210 participants who received ETI-204, 202 were included in the PK population. Reasons for exclusion were: missing dosing record (1), discontinued study drug due to an AE (6) and mechanical issues with the infusion pump (1). 3 additional participants were excluded from the AUC0-last calculation because of missing PK collection time points. | µg.day/mL | MEAN |
| SECONDARY | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | In addition, for several participants, certain PK parameter values were set to missing for the purposes of calculating descriptive statistics in the primary analysis, in accordance with the SAP. The extrapolated portion of AUC(0-inf) exceeded 20% of AUC(0-inf) in 8 participants, therefore, AUC(0-inf) was not reported for these individuals. | µg.day/mL | MEAN |
| SECONDARY | Terminal Half-life (t1/2) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | In addition, for several participants, certain PK parameter values were set to missing for the purposes of calculating descriptive statistics in the primary analysis, in accordance with the SAP. ETI-204 t1/2 values were not reported for 6 participants as they were greater than 50% of the 71-day sample collection interval. | days | MEAN |
| SECONDARY | Systemic Clearance (CL) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | In addition, for several participants, certain PK parameter values were set to missing for the purposes of calculating descriptive statistics in the primary analysis, in accordance with the SAP. The extrapolated portion of AUC(0-inf) exceeded 20% of AUC(0-inf) in 8 participants, therefore, CL was not reported for these individuals. | Liters/day | MEAN |
| SECONDARY | Volume of Distribution (Vd) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | In addition, for several participants, certain PK parameter values were set to missing for the purposes of calculating descriptive statistics in the primary analysis, in accordance with the SAP. The extrapolated portion of AUC(0-inf) exceeded 20% of AUC(0-inf) in 8 participants, therefore, Vd was not reported for these individuals. | Liters | MEAN |
| SECONDARY | Volume of Distribution at Steady State (Vss) | On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71. | In addition, for several participants, certain PK parameter values were set to missing for the purposes of calculating descriptive statistics in the primary analysis, in accordance with the SAP. The extrapolated portion of AUC(0-inf) exceeded 20% of AUC(0-inf) in 8 participants, therefore, Vss was not reported for these individuals. | Liters | MEAN |
| SECONDARY | Number of Participants With Anti-ETI-204 Antibodies | On Day 1 prior to the start of infusion and on Days 8, 43, and 71. | All participants who received study drug and were included in the safety population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced Adverse Events | ETI-204 | 88 | Participants | ||
| Number of Participants Who Experienced Adverse Events | Placebo | 27 | Participants | ||
| Maximum Observed Plasma Concentration of ETI-204 (Cmax) | ETI-204 | 400 | Standard Deviation 91.2 | µg/mL | |
| Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax) | ETI-204 | 0.0782 | Full Range 0.0674 to 1.01 | days | |
| Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) | ETI-204 | 4770 | Standard Deviation 1160 | µg.day/mL | |
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) | ETI-204 | 5170 | Standard Deviation 1360 | µg.day/mL | |
| Terminal Half-life (t1/2) | ETI-204 | 20.2 | Standard Deviation 5.26 | days | |
| Systemic Clearance (CL) | ETI-204 | 0.270 | Standard Deviation 0.0886 | Liters/day | |
| Volume of Distribution (Vd) | ETI-204 | 7.41 | Standard Deviation 1.90 | Liters | |
| Volume of Distribution at Steady State (Vss) | ETI-204 | 6.34 | Standard Deviation 1.55 | Liters |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ETI-204 | 210 | |
| Overall Study | STARTED | Placebo | 70 | |
| Overall Study | COMPLETED | ETI-204 | 205 | |
| Overall Study | COMPLETED | Placebo | 69 | |
| Overall Study | NOT COMPLETED | ETI-204 | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | ETI-204 | 0 | 210 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 70 | |
| other | Nausea | Gastrointestinal disorders | ETI-204 | 5 | 210 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 70 | |
| other | Infusion site erythema | General disorders | ETI-204 | 0 | 210 | |
| other | Infusion site erythema | General disorders | Placebo | 2 | 70 | |
| other | Pain | General disorders | ETI-204 | 3 | 210 | |
| other | Pain | General disorders | Placebo | 2 | 70 | |
| other | Vessel puncture site bruise | General disorders | ETI-204 | 7 | 210 | |
| other | Vessel puncture site bruise | General disorders | Placebo | 1 | 70 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ETI-204 | 0 | 210 |
| Total, all-cause mortality | Placebo | 0 | 70 |
| Total, other adverse events | ETI-204 | 52 | 210 |
| Total, other adverse events | Placebo | 18 | 70 |
| Total, serious adverse events | ETI-204 | 0 | 210 |
| Total, serious adverse events | Placebo | 1 | 70 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27568215 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ETI-204 vs Placebo: Number of Participants With Anti-ETI-204 Antibodies | Trial comparisons |
| ETI-204 vs Placebo: Number of Participants Who Experienced Adverse Events | Trial comparisons |
| ETI-204 vs Placebo: deaths from any cause | Trial comparisons |
| ETI-204 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01929226
GET https://conductscience.org/api/trials/v1/NCT01929226/events?page=2