Viral InfectionPhase 1NCT02696291
Safety and Pharmacokinetics of UV-4B Solution Administered Orally as Multiple Ascending Doses to Healthy Subjects
A Phase 1 study testing UV-4B 30 mg oral solution, UV-4B 75 mg oral solution and UV-4B 150 mg oral solution in people with Viral Infection, run by Emergent BioSolutions at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Infection
- What is being tested?
- UV-4B 30 mg oral solution, UV-4B 75 mg oral solution and UV-4B 150 mg oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 May 2016to 2 Mar 2017
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nonsmoking, healthy male or female subject aged 18 to 45 years, inclusive.
- Female subject is not pregnant and not lactating.
- (Female subjects only who are not postmenopausal or sterile) agreement to use hormonal contraception OR intrauterine device PLUS barrier contraception (condom or occlusive cap such as a diaphragm or surgical vault cap) AND spermicidal foam/gel/cream/suppository starting at least 14 days before the first dose and continuing for at least 3 months after the last dose.
- (Male subjects only) agreement to use barrier contraception during sexual intercourse and to also refrain from sperm donation from the first day of dosing until 3 months after the last dose of the study product.
- Body weight within 60 to 90 kg, inclusive, and body mass index between 18 to 32 kg/m², inclusive.
- Agreement to avoid strenuous exercise starting 4 days before the start of dosing through the period of confinement in the clinical unit and for at least 96 hours before the follow-up visits.
Who cannot join
- History of allergy to drugs in the iminosugar class.
- Treatment with any investigational products or therapies within 30 days (or 5 half-lives, whichever is greater) before the first day of dosing.
- Current or past history of disease/dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal genitourinary, or other body system.
- Abnormalities on physical examination suggestive of conditions that may pose an increased risk to the subject; abnormal electrocardiogram results (excluding benign conditions); and Grade 1 or higher abnormalities in vital signs at screening and Grade 2 or higher abnormalities in vital signs at check-in based on a modified version of the FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
- Clinical laboratory tests outside the normal range at screening and Grade 2 or higher at check-in to the clinical unit.
- Creatinine clearance < 90 mL/min (based on Cockcroft-Gault equation).
Show all 16Show fewer
- Proteinuria greater than or equal to 1+.
- Any known or expected risk of bleeding.
- Scheduled surgical procedure during study participation.
- History of alcohol and/or drug abuse within 1 year prior to dosing and/or a positive urine drug screen for substances of abuse at screening or check-in. Urine alcohol above 50 mg/dL.
- Plasma or blood donation within 30 days before the first day of dosing or intention to donate within 30 days after the final day of dosing.
- Treatment with any medication, either prescription or nonprescription, including dietary supplements or herbal medications, within 14 days before dosing (within 30 days before dosing for hepatic or renal clearance-altering agents) and is unable to refrain from any medication during the study period. Exceptions are acetaminophen (not more than 2 g/day), vitamin products at recommended daily doses or hormonal birth control.
- Positive serology test for HIV antibodies, hepatitis B surface antigen, or hepatitis C virus antibody at screening.
- History of relevant food allergies (ie, eggs or other components of standard clinic meals) or unwilling to comply with diet restrictions.
- Psychological and/or emotional problems which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements;
- Concurrent enrollment in any other clinical trial within 30 days.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Research Unit
Dallas, Texas, 75247
Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
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.
Read the detailed description
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.
- Conditions
- Viral Infection
- Being tested
- UV-4B 30 mg oral solution, UV-4B 75 mg oral solution, UV-4B 150 mg oral solution, UV-4B X mg (dose to be determined) oral solution, UV-4B Y mg (dose to be determined) oral solution
- Keywords
- Dengue, Arbovirus Infections, Flaviviridae Infections, Flavivirus Infections, Hemorrhagic Fevers, Viral, RNA Virus Infections, Virus Diseases, Pharmaceutical Solutions, Pharmacologic Actions, Therapeutic Uses
- Medical subject headings
- Virus Diseases, Dengue, Arbovirus Infections, Flaviviridae Infections, Flavivirus Infections, Hemorrhagic Fevers, Viral, RNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV-4B 30 mg oral solutionDrug
UV-4B 30 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days
UV-4B 75 mg oral solutionDrug
UV-4B 75 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days
UV-4B 150 mg oral solutionDrug
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 solutionDrug
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 solutionDrug
UV-4B Y mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days
PlaceboDrug
Placebo oral solution administered TID (every 8 ± 0.5 hours) for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - 30 mg | Experimental | Subjects receiving UV-4B 30 mg oral solution or placebo Receives: Drug: UV-4B 30 mg oral solution; Drug: Placebo |
| Cohort 2 - 75 mg | Experimental | Subjects receiving UV-4B 75 mg oral solution or placebo Receives: Drug: UV-4B 75 mg oral solution; Drug: Placebo |
| Cohort 3 - 150 mg | Experimental | Subjects receiving UV-4B 150 mg oral solution or placebo Receives: Drug: UV-4B 150 mg oral solution; Drug: Placebo |
| Cohort 4 - X mg (dose to be determined) | Experimental | Subjects receiving UV-4B X mg (dose to be determined) oral solution or placebo Receives: Drug: UV-4B X mg (dose to be determined) oral solution; Drug: Placebo |
| Cohort 5 - Y mg (dose to be determined) | Experimental | Subjects receiving UV-4B Y mg (dose to be determined) oral solution or placebo Receives: Drug: UV-4B Y mg (dose to be determined) oral solution; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From the time of first dosing on Day 1 through the Day 15 final follow-up visit
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7
Accumulation Ratio (AR)
Accumulation Ratio (AR) Day 1/Day 7
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study start27 May 2016
- Primary completion2 Mar 2017
- Study completion2 Mar 2017
Why it stopped: Product development halted for business reasons.
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 Viral InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Babinchak, MD, Study director, Emergent BioSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696291
- Sponsor's protocol ID
- DMID 15-0062
- Other IDs
- HHSN272201100030C, 8311-270
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2016
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02696291
- Acronym / sponsor ID
- DMID 15-0062
- Conditions
- Viral Infection
- Keywords
- Dengue, Arbovirus Infections, Flaviviridae Infections, Flavivirus Infections, Hemorrhagic Fevers, Viral, RNA Virus Infections, Virus Diseases, Pharmaceutical Solutions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Product development halted for business reasons.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 27 May 2016 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Posted 16 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - 30 mg | Experimental | Drug: UV-4B 30 mg oral solution, Drug: PlaceboSubjects receiving UV-4B 30 mg oral solution or placebo |
| Cohort 2 - 75 mg | Experimental | Drug: UV-4B 75 mg oral solution, Drug: PlaceboSubjects receiving UV-4B 75 mg oral solution or placebo |
| Cohort 3 - 150 mg | Experimental | Drug: UV-4B 150 mg oral solution, Drug: PlaceboSubjects receiving UV-4B 150 mg oral solution or placebo |
| Cohort 4 - X mg (dose to be determined) | Experimental | Drug: UV-4B X mg (dose to be determined) oral solution, Drug: PlaceboSubjects receiving UV-4B X mg (dose to be determined) oral solution or placebo |
| Cohort 5 - Y mg (dose to be determined) | Experimental | Drug: UV-4B Y mg (dose to be determined) oral solution, Drug: PlaceboSubjects receiving UV-4B Y mg (dose to be determined) oral solution or placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Nonsmoking, healthy male or female subject aged 18 to 45 years, inclusive.
- Female subject is not pregnant and not lactating.
- (Female subjects only who are not postmenopausal or sterile) agreement to use hormonal contraception OR intrauterine device PLUS barrier contraception (condom or occlusive cap such as a diaphragm or surgical vault cap) AND spermicidal foam/gel/cream/suppository starting at least 14 days before the first dose and continuing for at least 3 months after the last dose.
- (Male subjects only) agreement to use barrier contraception during sexual intercourse and to also refrain from sperm donation from the first day of dosing until 3 months after the last dose of the study product.
- Body weight within 60 to 90 kg, inclusive, and body mass index between 18 to 32 kg/m², inclusive.
Key exclusion criteria (16 listed)
- History of allergy to drugs in the iminosugar class.
- Treatment with any investigational products or therapies within 30 days (or 5 half-lives, whichever is greater) before the first day of dosing.
- Current or past history of disease/dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal genitourinary, or other body system.
- Abnormalities on physical examination suggestive of conditions that may pose an increased risk to the subject; abnormal electrocardiogram results (excluding benign conditions); and Grade 1 or higher abnormalities in vital signs at screening and Grade 2 or higher abnormalities in vital signs at check-in based on a modified version of the FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
- Clinical laboratory tests outside the normal range at screening and Grade 2 or higher at check-in to the clinical unit.
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 |
|---|---|---|
| UV-4B 30 mg oral solutionUV-4B 30 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days | Drug | Cohort 1 - 30 mg |
| UV-4B 75 mg oral solutionUV-4B 75 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days | Drug | Cohort 2 - 75 mg |
| UV-4B 150 mg oral solutionUV-4B 150 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days | Drug | Cohort 3 - 150 mg |
| UV-4B X mg (dose to be determined) oral solutionUV-4B X mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days | Drug | Cohort 4 - X mg (dose to be determined) |
| UV-4B Y mg (dose to be determined) oral solutionUV-4B Y mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days | Drug | Cohort 5 - Y mg (dose to be determined) |
| PlaceboPlacebo oral solution administered TID (every 8 ± 0.5 hours) for 7 days | Drug | Cohort 1 - 30 mg, Cohort 2 - 75 mg, Cohort 3 - 150 mg, Cohort 4 - X mg (dose to be determined), Cohort 5 - Y mg (dose to be determined) |
Primary outcome
Number of Subjects Reporting Treatment-emergent Adverse Events (TEAEs) by Group
Time frame: From the time of first dosing on Day 1 through the Day 15 final follow-up visit
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.
Number of Subjects Reporting Serious Adverse Events (SAEs) by Group
Time frame: From the time of first dosing on Day 1 through the Day 15 final follow-up visit
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.
Number of Subjects With Clinical Laboratory Abnormalities of Toxicity Grade 1 or Higher by Group
Time frame: From the time of first dosing on Day 1 through the Day 15 final follow-up visit
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.
11 secondary outcomes
Number of Subjects With Outlying Vital Sign Results by Group
Time frame: 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
Time frame: From the time of first dosing on Day 1 through the Day 15 final follow-up visit
Maximum Plasma Concentration (Cmax)
Time frame: Day 1, Day 7
Time of Maximum Plasma Concentration (Tmax)
Time frame: 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)]
Time frame: 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)]
Time frame: Day 7
Area Under the Concentration-time Curve From Time Zero (Predose) Until 8 Hours After the Final Dose [AUC(0-8)]
Time frame: Day 1, Day 7
Apparent Systemic Clearance (CL/F) at Steady State
Time frame: Day 7
Apparent Volume of Distribution of UV-4 During the Terminal Phase (Vz/F) After Multiple Doses
Time frame: Day 7
Apparent Terminal Half Life (t1/2)
Time frame: Day 7
Accumulation Ratio (AR)
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- For information on dengue feverLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Timothy Babinchak, MD study director
Emergent BioSolutions
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UV-4B 30 mg oral solution, UV-4B 75 mg oral solution and UV-4B 150 mg oral solution in people with Viral Infection, run by Emergent BioSolutions at 2 sites 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 16 Mar 2018). 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 Subjects Reporting Treatment-emergent Adverse Events (TEAEs) by Group (time frame: From the time of first dosing on Day 1 through the Day 15 final follow-up visit). The study lists 3 primary outcomes in all. 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 18 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.