NCT02061358: UV

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

Completed Phase 1 Results posted Last updated 14 March 2024

What this trial tests

Phase 1 trial testing UV-4B 3 mg in Viral Infection in 64 participants. Completed in 1 September 2015.

Timeline

1 July 2014

Primary endpoint
1 July 2015

1 September 2015

Quick facts

Lead sponsor	Emergent BioSolutions
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	1 July 2014
Primary completion	1 July 2015
Estimated completion	1 September 2015
Sites	1 location across United States

Drugs / interventions tested

• UV-4B 3 mg — full drug profile →
• UV-4B 10 mg — full drug profile →
• UV-4B 30 mg
• UV-4B 90 mg
• UV-4B 180 mg — full drug profile →
• UV-4B 360 mg — full drug profile →
• UV-4B 720 mg — full drug profile →
• UV-4B 1000 mg
• Placebo

Conditions studied

• Viral Infection — all drugs for Viral Infection →

Sponsor

Emergent BioSolutions — full company profile →

Who can join

Adults 18 to 45, any sex, with Viral Infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Medicinal chemistry strategies toward host targeting antiviral agents.
   Ji X, Li Z. · · 2020 · cited 79× · PMID 32060956 · DOI 10.1002/med.21664
2. Dengue: Update on Clinically Relevant Therapeutic Strategies and Vaccines.
   Palanichamy Kala M, St John AL, Rathore APS. · · 2023 · cited 64× · PMID 37124673 · DOI 10.1007/s40506-023-00263-w
3. Dengue virus pathogenesis and host molecular machineries.
   Sinha S, Singh K, Ravi Kumar YS, Roy R, et al · · 2024 · cited 58× · PMID 38649998 · DOI 10.1186/s12929-024-01030-9
4. Inhibition of endoplasmic reticulum glucosidases is required for in vitro and in vivo dengue antiviral activity by the iminosugar UV-4.
   Warfield KL, Plummer EM, Sayce AC, Alonzi DS, et al · · 2016 · cited 57× · PMID 26946111 · DOI 10.1016/j.antiviral.2016.03.001
5. Iminosugars: A host-targeted approach to combat Flaviviridae infections.
   Evans DeWald L, Starr C, Butters T, Treston A, et al · · 2020 · cited 31× · PMID 32768411 · DOI 10.1016/j.antiviral.2020.104881
6. Mechanisms of Antiviral Activity of Iminosugars Against Dengue Virus.
   Miller JL, Tyrrell BE, Zitzmann N. · · 2018 · cited 31× · PMID 29845540 · DOI 10.1007/978-981-10-8727-1_20
7. Enhancing the antiviral potency of ER α-glucosidase inhibitor IHVR-19029 against hemorrhagic fever viruses in vitro and in vivo.
   Ma J, Zhang X, Soloveva V, Warren T, et al · · 2018 · cited 27× · PMID 29253498 · DOI 10.1016/j.antiviral.2017.12.008
8. Randomized single oral dose phase 1 study of safety, tolerability, and pharmacokinetics of Iminosugar UV-4 Hydrochloride (UV-4B) in healthy subjects.
   Callahan M, Treston AM, Lin G, Smith M, et al · · 2022 · cited 21× · PMID 35939501 · DOI 10.1371/journal.pntd.0010636