Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HHSN272201100030C | Other Grant/Funding Number | NIAID | |
| 8311-270 | Other Identifier | Covance |
Not provided
Not provided
Not provided
Product development halted for business reasons.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and pharmacokinetics of UV-4B oral solution when administered to healthy subjects three times a day (TID) for 7 days.
This is a phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose study to evaluate the safety and pharmacokinetics of UV-4B oral solution when administered to healthy subjects TID for 7 days. Three cohorts of 8 subjects each (6 active, 2 placebo) are planned and up to 2 additional cohorts may be added pending safety review of the initial cohorts. Safety review will occur after each cohort. Safety is evaluated through Day 15 on the basis of adverse event (AE) monitoring, clinical laboratory testing (hematology, serum chemistry, coagulation, urinalysis), vital signs, physical examinations (PE), electrocardiograms (ECG), and fecal occult blood testing. Blood samples are collected at specified intervals up to Day 10 for pharmacokinetic assessment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - 30 mg | Experimental | Subjects receiving UV-4B 30 mg oral solution or placebo |
|
| Cohort 2 - 75 mg | Experimental | Subjects receiving UV-4B 75 mg oral solution or placebo |
|
| Cohort 3 - 150 mg | Experimental | Subjects receiving UV-4B 150 mg oral solution or placebo |
|
| Cohort 4 - X mg (dose to be determined) | Experimental | Subjects receiving UV-4B X mg (dose to be determined) oral solution or placebo |
|
| Cohort 5 - Y mg (dose to be determined) | Experimental | Subjects receiving UV-4B Y mg (dose to be determined) oral solution or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UV-4B 30 mg oral solution | Drug | UV-4B 30 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Treatment-emergent Adverse Events (TEAEs) by Group | The incidence of TEAEs spontaneously reported by subjects or elicited during examination is reported by dose group. Subjects having multiple TEAEs are counted only once. | From the time of first dosing on Day 1 through the Day 15 final follow-up visit |
| Number of Subjects Reporting Serious Adverse Events (SAEs) by Group | The incidence of SAEs spontaneously reported by subjects or elicited during examination is reported by dose group. Subjects having multiple SAEs are counted only once. | From the time of first dosing on Day 1 through the Day 15 final follow-up visit |
| Number of Subjects With Clinical Laboratory Abnormalities of Toxicity Grade 1 or Higher by Group | Clinical laboratory abnormalities are presented as the total of Grade 1 (mild) through Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the Food and Drug Administration (FDA) Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) and the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table (November 2007). Within each parameter, subjects having multiple abnormalities are counted only once. | From the time of first dosing on Day 1 through the Day 15 final follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Outlying Vital Sign Results by Group | Vital signs of blood pressure (BP), pulse, respiratory rate, and oral temperature were taken after being supine for 10 minutes. Orthostatic vital signs (BP, pulse) were taken after 2 minutes standing. Vital sign results are presented as the number of subjects having Grade 1 (mild) through Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the FDA Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007), or having abnormal orthostatic change (standing minus supine result). Within each parameter, subjects having multiple abnormalities are counted only once. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy Babinchak, MD | Emergent BioSolutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Unit | Dallas | Texas | 75247 | United States | ||
| Clinical Research Unit |
Not provided
| Label | URL |
|---|---|
| For information on dengue fever | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Healthy subjects were recruited from a phase 1 clinical research unit. Recruitment was initiated on 27 May 2016 and the last subject completed the final study visit for Cohort 1 on 02 March 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - 30 mg UV-4B | Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days |
| FG001 | Cohort 1 - Placebo | Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2017 | Feb 15, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| UV-4B 75 mg oral solution | Drug | UV-4B 75 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days |
|
| UV-4B 150 mg oral solution | Drug | UV-4B 150 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days |
|
| UV-4B X mg (dose to be determined) oral solution | Drug | UV-4B X mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days |
|
| UV-4B Y mg (dose to be determined) oral solution | Drug | UV-4B Y mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days |
|
| Placebo | Drug | Placebo oral solution administered TID (every 8 ± 0.5 hours) for 7 days |
|
| From the time of first dosing on Day 1 through the Day 15 final follow-up visit |
| Number of Subjects With 12-lead Electrocardiogram (ECG) Abnormalities Postdose by Group | ECGs (ventricular heart rate, wave intervals - PR, QRS, QT, QTcF) were recorded in a supine position (for at least 10 minutes). Baseline was calculated from the average of the triplicate ECGs on Day 1 predose. Within each parameter, subjects having multiple abnormalities are counted only once. | From the time of first dosing on Day 1 through the Day 15 final follow-up visit |
| Maximum Plasma Concentration (Cmax) | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of Cmax are derived from individual subject plasma concentration-time data. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Day 1, Day 7 |
| Time of Maximum Plasma Concentration (Tmax) | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of tmax are derived from individual subject plasma concentration-time data. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Day 1, Day 7 |
| Area Under the Concentration-time Curve From Time Zero (Predose) to Time of the Last Quantifiable Concentration After the Last Dose [AUC(0-last)] | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-last) are derived from individual subject plasma concentration-time data, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Day 7 |
| Total Daily Exposure at Steady State: Area Under the Concentration-time Curve From Time Zero (Predose) Until 24 Hours After the Last Dose [AUC(0-24)] | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-24) are derived from individual subject plasma concentration-time data, calculated as AUC(0-8) x 3 (Day 7 last dose only). Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Day 7 |
| Area Under the Concentration-time Curve From Time Zero (Predose) Until 8 Hours After the Final Dose [AUC(0-8)] | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-8) are derived from individual subject plasma concentration-time data, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Day 1, Day 7 |
| Apparent Systemic Clearance (CL/F) at Steady State | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of CL/F are derived from individual subject plasma concentration-time data, calculated as dose (free-base equivalent) divided by AUC(0-8). Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Day 7 |
| Apparent Volume of Distribution of UV-4 During the Terminal Phase (Vz/F) After Multiple Doses | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of Vz/F are derived from individual subject plasma concentration-time data, calculated as CL/F divided by λz. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Day 7 |
| Apparent Terminal Half Life (t1/2) | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of t1/2 are derived from individual subject plasma concentration-time data, calculated as ln2/λz. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Day 7 |
| Accumulation Ratio (AR) | Accumulation Ratio (AR) Day 1/Day 7 | Day 7 |
| Madison |
| Wisconsin |
| 53704 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - 30 mg UV-4B | Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days |
| BG001 | Cohort 1 - Placebo | Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Reporting Treatment-emergent Adverse Events (TEAEs) by Group | The incidence of TEAEs spontaneously reported by subjects or elicited during examination is reported by dose group. Subjects having multiple TEAEs are counted only once. | Safety Population: all subjects who received at least one dose of study product or placebo. | Posted | Count of Participants | Participants | From the time of first dosing on Day 1 through the Day 15 final follow-up visit |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) by Group | The incidence of SAEs spontaneously reported by subjects or elicited during examination is reported by dose group. Subjects having multiple SAEs are counted only once. | Safety Population: all subjects who received at least one dose of study product or placebo. | Posted | Count of Participants | Participants | From the time of first dosing on Day 1 through the Day 15 final follow-up visit |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Clinical Laboratory Abnormalities of Toxicity Grade 1 or Higher by Group | Clinical laboratory abnormalities are presented as the total of Grade 1 (mild) through Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the Food and Drug Administration (FDA) Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) and the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table (November 2007). Within each parameter, subjects having multiple abnormalities are counted only once. | Safety Population: all subjects who received at least one dose of study product or placebo. | Posted | Count of Participants | Participants | From the time of first dosing on Day 1 through the Day 15 final follow-up visit |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Outlying Vital Sign Results by Group | Vital signs of blood pressure (BP), pulse, respiratory rate, and oral temperature were taken after being supine for 10 minutes. Orthostatic vital signs (BP, pulse) were taken after 2 minutes standing. Vital sign results are presented as the number of subjects having Grade 1 (mild) through Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the FDA Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007), or having abnormal orthostatic change (standing minus supine result). Within each parameter, subjects having multiple abnormalities are counted only once. | Safety Population: all subjects who received at least one dose of study product or placebo. | Posted | Count of Participants | Participants | From the time of first dosing on Day 1 through the Day 15 final follow-up visit |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With 12-lead Electrocardiogram (ECG) Abnormalities Postdose by Group | ECGs (ventricular heart rate, wave intervals - PR, QRS, QT, QTcF) were recorded in a supine position (for at least 10 minutes). Baseline was calculated from the average of the triplicate ECGs on Day 1 predose. Within each parameter, subjects having multiple abnormalities are counted only once. | Safety Population: all subjects who received at least one dose of study product or placebo. | Posted | Count of Participants | Participants | From the time of first dosing on Day 1 through the Day 15 final follow-up visit |
|
| ||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of Cmax are derived from individual subject plasma concentration-time data. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1, Day 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Time of Maximum Plasma Concentration (Tmax) | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of tmax are derived from individual subject plasma concentration-time data. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug. | Posted | Mean | Standard Deviation | h | Day 1, Day 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve From Time Zero (Predose) to Time of the Last Quantifiable Concentration After the Last Dose [AUC(0-last)] | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-last) are derived from individual subject plasma concentration-time data, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Total Daily Exposure at Steady State: Area Under the Concentration-time Curve From Time Zero (Predose) Until 24 Hours After the Last Dose [AUC(0-24)] | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-24) are derived from individual subject plasma concentration-time data, calculated as AUC(0-8) x 3 (Day 7 last dose only). Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve From Time Zero (Predose) Until 8 Hours After the Final Dose [AUC(0-8)] | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-8) are derived from individual subject plasma concentration-time data, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1, Day 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Apparent Systemic Clearance (CL/F) at Steady State | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of CL/F are derived from individual subject plasma concentration-time data, calculated as dose (free-base equivalent) divided by AUC(0-8). Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Day 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution of UV-4 During the Terminal Phase (Vz/F) After Multiple Doses | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of Vz/F are derived from individual subject plasma concentration-time data, calculated as CL/F divided by λz. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Day 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Half Life (t1/2) | Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of t1/2 are derived from individual subject plasma concentration-time data, calculated as ln2/λz. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7. | Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug. | Posted | Median | Full Range | h | Day 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Accumulation Ratio (AR) | Accumulation Ratio (AR) Day 1/Day 7 | Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Day 7 |
|
|
Up to Day 15.
On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 15.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 - 30 mg UV-4B | Subjects receiving UV-4B 30 mg oral solution TID (every 8 ± 0.5 hours) for 7 days | 0 | 5 | 1 | 5 | 5 | 5 |
| EG001 | Cohort 1 - Placebo | Subjects receiving placebo TID (every 8 ± 0.5 hours) for 7 days | 0 | 2 | 0 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Testis discomfort | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
Study was terminated after Cohort 1. While no analysis was performed for change from baseline for physical exam (PE, a secondary endpoint), any change from baseline PE was reported/analyzed as an AE. AUC0-inf (secondary endpoint) was not calculated.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Babinchak, MD | Emergent Product Development Gaithersburg, Inc. | (240) 631-3585 | tbabinchak@ebsi.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2017 | Feb 15, 2018 | SAP_000.pdf |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D003715 | Dengue |
| D001102 | Arbovirus Infections |
| D018178 | Flaviviridae Infections |
| D018177 | Flavivirus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|