Viral InfectionPhase 1UVNCT02061358

Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

A Phase 1 study testing UV-4B 3 mg, UV-4B 10 mg and UV-4B 30 mg in people with Viral Infection, run by Emergent BioSolutions at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects. 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 3 mg, UV-4B 10 mg and UV-4B 30 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Sep 2015
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

Healthy subjects
Women: non-pregnant, non-lactating; if of childbearing potential, on specified contraception measures during the study period
Men: using barrier contraception measures during the study period

Who cannot join

Health conditions
Taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins, hormonal birth control)

Trial locations and contacts

1 site in 1 country.

United States1 site

Quintiles, Inc
Overland Park, Kansas, 66211

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single-Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

Read the detailed description

The causative agent of dengue fever is Dengue Virus (DENV), a member of the flavivirus genus. There are four DENV serotypes. Infection with one serotype results in lifelong immunity against that serotype, but only limited short-term cross-protection from infection with the other serotypes. Immunity to one serotype has a downside as subsequent infections by other serotypes increase the risk of developing more severe forms of dengue, which includes the most lethal form of the disease, dengue hemorrhagic fever. Traditional epidemiologic and serologic-based estimates suggest a range of 50 to 100 million DENV infections per year distributed over 100 countries. Recent cartographic-based modeling studies suggest that up to 390 million of dengue infections per year, of which 96 million are associated with clinical symptoms.

Conditions: Viral Infection
Being tested: UV-4B 3 mg, UV-4B 10 mg, UV-4B 30 mg, UV-4B 90 mg, UV-4B 180 mg
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 3 mgDrug
Oral solution, single dose
UV-4B 10 mgDrug
Oral solution, single dose
UV-4B 30 mgDrug
Oral solution, single dose
UV-4B 90 mgDrug
Oral solution, single dose
UV-4B 180 mgDrug
Oral solution, single dose
UV-4B 360 mgDrug
Oral solution, single dose
UV-4B 720 mgDrug
Oral solution, single dose
UV-4B 1000 mgDrug
Oral solution, single dose
PlaceboDrug
Oral solution, single dose

Study groups in NCT02061358
Study group	Role	What they receive
Cohort 1 - 3 mg UV-4B	Experimental	Subjects receiving UV-4B 3 mg oral solution or placebo Receives: Drug: UV-4B 3 mg; Drug: Placebo
Cohort 2 - 10 mg UV-4B	Experimental	Subjects receiving UV-4B 10 mg oral solution or placebo Receives: Drug: UV-4B 10 mg; Drug: Placebo
Cohort 3- 30 mg UV-4B	Experimental	Subjects receiving UV-4B 30 mg oral solution or placebo Receives: Drug: UV-4B 30 mg; Drug: Placebo
Cohort 4 - 90 mg UV-4B	Experimental	Subjects receiving UV-4B 90 mg oral solution or placebo Receives: Drug: UV-4B 90 mg; Drug: Placebo
Cohort 5 - 180 mg UV-4B	Experimental	Subjects receiving UV-4B 180 mg oral solution or placebo Receives: Drug: UV-4B 180 mg; Drug: Placebo
Cohort 6 - 360 mg UV-4B	Experimental	Subjects receiving UV-4B 360 mg oral solution or placebo Receives: Drug: UV-4B 360 mg; Drug: Placebo
Cohort 7 - 720 mg UV-4B	Experimental	Subjects receiving UV-4B 720 mg oral solution or placebo Receives: Drug: UV-4B 720 mg; Drug: Placebo
Cohort 8 - 1000 mg UV-4B	Experimental	Subjects receiving UV-4B 1000 mg oral solution or placebo Receives: Drug: UV-4B 1000 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group
TEAEs are those AEs occurring only after administration of investigational product
Measured: From time of the first dose administration through Day 9 ± 1
Subjects With Serious Adverse Event (SAEs) by Treatment Group
Subjects with AEs considered serious by the investigator
Measured: From time of the first dose administration through Day 9 ± 1
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Number of subjects in a treatment group, who had a vital sign value of toxicity Grade 1 or higher: supine and standing systolic blood pressure (BP), supine and standing diastolic BP, supine and standing pulse rate, respiratory rate, and temperature
Measured: From time of the first dose administration through Day 9 ± 1
Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group
Number of subjects in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals
Measured: From time of the first dose administration through Day 9 ± 1
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Number of subjects with Grade 1 toxicity or higher for hematology, coagulation, chemistry and urinalysis analytes. ULN=upper limit of normal; WBC=white blood cell count.
Measured: Day 9 ± 1

Secondary outcomes (10)

Cmax by Treatment Group: UV-4
Cmax is the maximum plasma concentration, obtained directly from the observed concentration versus time data.
Measured: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
Tmax by Treatment Group: UV-4
Tmax is the time of maximum concentration observed directly from the observed concentration versus time data.
Measured: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
AUC(0-last) by Treatment Group: UV-4
AUC(0-last) is the area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration, calculated by linear up/log down trapezoidal summation.
Measured: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
AUC(0-inf) by Treatment Group: UV-4
AUC(0-inf) is the area under the concentration-time curve in the sample from pre-dose extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant: AUC(0-last) - C(last)/λ(z).
Measured: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
CL/F by Treatment Group: UV-4
CL/F is the apparent systematic clearance, calculated as dose (free-base equivalent) divided by AUC(0-inf).
Measured: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
Vz/F by Treatment Group: UV-4
Vz/F is the apparent volume of distribution of UV-4 based on the terminal phase, calculated as dose (free-base equivalent) divided by [λ(z) × AUC(0-inf)].
Measured: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
t(1/2) by Treatment Group: UV-4
t(1/2) is the apparent terminal half-life, determined as ln(2)/λ(z).
Measured: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group
Ae is the by-interval and cumulative amounts of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. Ae by-interval amounts were calculated as the product of urine volume and urine concentration. Ae(0-last) is the cumulative amount of UV-4 drug excreted in urine over the entire collection period, 48 hours. Cumulative amounts were calculated as the summation of the amounts excreted in collection intervals.
Measured: Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose
Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group
fe is the by-interval percentage of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. fe = Ae/(UV-4B dose x 100). fe(0-12), fe(0-24) and fe(0-last) are the cumulative percentages of UV-4 drug excreted in urine over 24 hours and the entire collection period, respectively.
Measured: Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose
CLr by Treatment Group: UV-4
CLr is the renal clearance, calculated at Ae(0-last) divided by AUC(0-last).
Measured: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Sep 2015

First posted12 Feb 2014 (estimated)
Study startJul 2014
Primary completionJul 2015
Study completionSep 2015

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.
Publications (1)Papers the sponsor has linked to this study.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02061358
Sponsor's protocol ID: DMID 13-0001
Other IDs: KQA71264, UV-DEN-0001
Acronym: UV
Status last verified: Mar 2024
First submitted: 6 Feb 2014
Last updated: 18 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Callahan M, Treston AM, Lin G, Smith M, Kaufman B, Khaliq M, Evans DeWald L, Spurgers K, Warfield KL, Lowe P, Duchars M, Sampath A, Ramstedt U. Randomized single oral dose phase 1 study of safety, tolerability, and pharmacokinetics of Iminosugar UV-4 Hydrochloride (UV-4B) in healthy subjects. PLoS Negl Trop Dis. 2022 Aug 8;16(8):e0010636. doi: 10.1371/journal.pntd.0010636. eCollection 2022 Aug.
PubMed 35939501

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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, Parallel Group, Single-Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
ClinicalTrials.gov ID: NCT02061358
Acronym / sponsor ID: UV / DMID 13-0001
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: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Emergent BioSolutionsIndustry (pharma, biotech, devices)
Collaborators: Quintiles, Inc., Unither Virology
Study start: Jul 2014
Primary completion: Jul 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 12 Feb 2014 (estimated)
Results: Posted 1 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Cohort 1 - 3 mg UV-4B	Experimental	Drug: UV-4B 3 mg, Drug: PlaceboSubjects receiving UV-4B 3 mg oral solution or placebo
Cohort 2 - 10 mg UV-4B	Experimental	Drug: UV-4B 10 mg, Drug: PlaceboSubjects receiving UV-4B 10 mg oral solution or placebo
Cohort 3- 30 mg UV-4B	Experimental	Drug: UV-4B 30 mg, Drug: PlaceboSubjects receiving UV-4B 30 mg oral solution or placebo
Cohort 4 - 90 mg UV-4B	Experimental	Drug: UV-4B 90 mg, Drug: PlaceboSubjects receiving UV-4B 90 mg oral solution or placebo
Cohort 5 - 180 mg UV-4B	Experimental	Drug: UV-4B 180 mg, Drug: PlaceboSubjects receiving UV-4B 180 mg oral solution or placebo
Cohort 6 - 360 mg UV-4B	Experimental	Drug: UV-4B 360 mg, Drug: PlaceboSubjects receiving UV-4B 360 mg oral solution or placebo
Cohort 7 - 720 mg UV-4B	Experimental	Drug: UV-4B 720 mg, Drug: PlaceboSubjects receiving UV-4B 720 mg oral solution or placebo
Cohort 8 - 1000 mg UV-4B	Experimental	Drug: UV-4B 1000 mg, Drug: PlaceboSubjects receiving UV-4B 1000 mg oral solution or placebo

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy subjects
Women: non-pregnant, non-lactating; if of childbearing potential, on specified contraception measures during the study period
Men: using barrier contraception measures during the study period

Key exclusion criteria (2 listed)

Health conditions
Taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins, hormonal birth control)

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 3 mgOral solution, single dose	Drug	Cohort 1 - 3 mg UV-4B
UV-4B 10 mgOral solution, single dose	Drug	Cohort 2 - 10 mg UV-4B
UV-4B 30 mgOral solution, single dose	Drug	Cohort 3- 30 mg UV-4B
UV-4B 90 mgOral solution, single dose	Drug	Cohort 4 - 90 mg UV-4B
UV-4B 180 mgOral solution, single dose	Drug	Cohort 5 - 180 mg UV-4B
UV-4B 360 mgOral solution, single dose	Drug	Cohort 6 - 360 mg UV-4B
UV-4B 720 mgOral solution, single dose	Drug	Cohort 7 - 720 mg UV-4B
UV-4B 1000 mgOral solution, single dose	Drug	Cohort 8 - 1000 mg UV-4B
PlaceboOral solution, single dose	Drug	Cohort 1 - 3 mg UV-4B, Cohort 2 - 10 mg UV-4B, Cohort 3- 30 mg UV-4B, Cohort 4 - 90 mg UV-4B, Cohort 5 - 180 mg UV-4B, Cohort 6 - 360 mg UV-4B, Cohort 7 - 720 mg UV-4B, Cohort 8 - 1000 mg UV-4B

Primary outcome

Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group
Time frame: From time of the first dose administration through Day 9 ± 1
TEAEs are those AEs occurring only after administration of investigational product
Subjects With Serious Adverse Event (SAEs) by Treatment Group
Time frame: From time of the first dose administration through Day 9 ± 1
Subjects with AEs considered serious by the investigator
Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)
Time frame: From time of the first dose administration through Day 9 ± 1
Number of subjects in a treatment group, who had a vital sign value of toxicity Grade 1 or higher: supine and standing systolic blood pressure (BP), supine and standing diastolic BP, supine and standing pulse rate, respiratory rate, and temperature
Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group
Time frame: From time of the first dose administration through Day 9 ± 1
Number of subjects in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals
Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group
Time frame: Day 9 ± 1
Number of subjects with Grade 1 toxicity or higher for hematology, coagulation, chemistry and urinalysis analytes. ULN=upper limit of normal; WBC=white blood cell count.

10 secondary outcomes

Cmax by Treatment Group: UV-4
Time frame: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
Tmax by Treatment Group: UV-4
Time frame: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
AUC(0-last) by Treatment Group: UV-4
Time frame: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
AUC(0-inf) by Treatment Group: UV-4
Time frame: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
CL/F by Treatment Group: UV-4
Time frame: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
Vz/F by Treatment Group: UV-4
Time frame: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
t(1/2) by Treatment Group: UV-4
Time frame: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)
Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group
Time frame: Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose
Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group
Time frame: Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose
CLr by Treatment Group: UV-4
Time frame: Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)

Results and safety

Results posted to the registry on 1 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3 mg UV-4B	6	6
10 mg UV-4B	6	6
30 mg UV-4B	6	6
90 mg UV-4B	6	6
180 mg UV-4B	6	6
360 mg UV-4B	6	6
720 mg UV-4B	6	6
1000 mg UV-4B	6	6
Placebo	16	16

Primary outcome: Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group

Time frame: From time of the first dose administration through Day 9 ± 1. Number. Unit: Subjects with at least 1 TEAE

Measure	3 mg UV-4B n = 6	10 mg UV-4B n = 6	30 mg UV-4B n = 6	90 mg UV-4B n = 6	180 mg UV-4B n = 6	360 mg UV-4B n = 6	720 mg UV-4B n = 6	1000 mg UV-4B n = 6	Placebo n = 16
Value	5	6	5	5	6	5	6	5	12

Population analysed: Safety Population: all subjects who received any investigational product, UV-4B or placebo

Primary outcome: Subjects With Serious Adverse Event (SAEs) by Treatment Group

Time frame: From time of the first dose administration through Day 9 ± 1. Number. Unit: Subjects with at least 1 SAE

Measure	3 mg UV-4B n = 6	10 mg UV-4B n = 6	30 mg UV-4B n = 6	90 mg UV-4B n = 6	180 mg UV-4B n = 6	360 mg UV-4B n = 6	720 mg UV-4B n = 6	1000 mg UV-4B n = 6	Placebo n = 16
Value	0	0	0	0	0	0	0	0	0

Population analysed: Safety Population: all subjects who received any investigational product, UV-4B or placebo

Primary outcome: Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)

Time frame: From time of the first dose administration through Day 9 ± 1. Number. Unit: Participants

Measure	3 mg UV-4B n = 6	10 mg UV-4B n = 6	30 mg UV-4B n = 6	90 mg UV-4B n = 6	180 mg UV-4B n = 6	360 mg UV-4B n = 6	720 mg UV-4B n = 6	1000 mg UV-4B n = 6	Placebo n = 16
Subjects with any Grade 1 or higher	6	6	5	5	6	5	6	6	12
Supine systolic BP ≤ 89 mmHg	0	0	0	0	0	0	0	0	2
Supine systolic BP ≥ 141 mmHg	0	0	0	1	0	0	0	0	1
Standing systolic BP ≤ 89 mmHg	0	0	0	1	0	0	1	0	1
Standing systolic BP ≥ 141 mmHg	1	0	0	2	2	2	0	1	1
Supine diastolic BP ≥ 91 mmHg	0	0	1	0	0	0	0	0	0
Standing diastolic BP ≥ 91 mmHg	0	1	1	2	2	2	0	1	3
Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm	0	3	1	2	1	1	1	3	4

Population analysed: Safety Population: all subjects who received any investigational product, UV-4B or placebo

Primary outcome: Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group

Time frame: From time of the first dose administration through Day 9 ± 1. Number. Unit: participants

Measure	3 mg UV-4B n = 6	10 mg UV-4B n = 6	30 mg UV-4B n = 6	90 mg UV-4B n = 6	180 mg UV-4B n = 6	360 mg UV-4B n = 6	720 mg UV-4B n = 6	1000 mg UV-4B n = 6	Placebo n = 16
Subjects with an outlier value	0	0	0	0	0	0	0	0	0
QTcF > 450 ms (males) or > 470 ms (females)	0	0	0	0	0	0	0	0	0
QTcF > 500 ms	0	0	0	0	0	0	0	0	0
QTcF increase from baseline > 30 ms or ≤ 60 ms	0	0	0	0	0	0	0	0	0
QTcF increase from baseline > 220 ms	0	0	0	0	0	0	0	0	0
PR > 220 ms	0	0	0	0	0	0	0	0	0
QRS > 120 ms	0	0	0	0	0	0	0	0	0

Population analysed: Safety Population: all subjects who received any investigational product, UV-4B or placebo

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of the first dose administration through 9 ± 1 days after dosing. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3 mg UV-4B	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
10 mg UV-4B	0 of 6 (0%)	6 of 6 (100%)	Not reported
30 mg UV-4B	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
90 mg UV-4B	0 of 6 (0%)	6 of 6 (100%)	Not reported
180 mg UV-4B	0 of 6 (0%)	6 of 6 (100%)	Not reported
360 mg UV-4B	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
720 mg UV-4B	0 of 6 (0%)	6 of 6 (100%)	Not reported
1000 mg UV-4B	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Placebo	0 of 16 (0%)	12 of 16 (75%)	Not reported

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.
Derived from this study: PubMed 35939501Callahan M, Treston AM, Lin G, Smith M, Kaufman B, Khaliq M, Evans DeWald L, Spurgers K, Warfield KL, Lowe P, Duchars M, Sampath A, Ramstedt U. Randomized single oral dose phase 1 study of safety, tolerability, and pharmacokinetics of Iminosugar UV-4 Hydrochloride (UV-4B) in healthy subjects. PLoS Negl Trop Dis. 2022 Aug 8;16(8):e0010636. doi: 10.1371/journal.pntd.0010636. eCollection 2022 Aug.
Information on dengue feverLink provided by the sponsor.
Individual participant dataSharing planned: No

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VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)

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.

Thomas Murtaugh, Dr principal investigator

Senior Medical Research Director, Quintiles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UV-4B 3 mg, UV-4B 10 mg and UV-4B 30 mg in people with Viral Infection, run by Emergent BioSolutions at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 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 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2016). 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?

Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group (time frame: From time of the first dose administration through Day 9 ± 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02061358, which also lists 1 linked publication.

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.