Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UV-4B · 1 trial · 1 indication
TEAEs are those AEs occurring only after administration of investigational product
Subjects with AEs considered serious by the investigator
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 in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals
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.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - 3 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 3 mg oral solution or placebo |
| Cohort 2 - 10 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 10 mg oral solution or placebo |
| Cohort 3- 30 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 30 mg oral solution or placebo |
| Cohort 4 - 90 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 90 mg oral solution or placebo |
| Cohort 5 - 180 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 180 mg oral solution or placebo |
| Cohort 6 - 360 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 360 mg oral solution or placebo |
| Cohort 7 - 720 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 720 mg oral solution or placebo |
| Cohort 8 - 1000 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 1000 mg oral solution or placebo |
| Name | Type | Description |
|---|---|---|
| UV-4B 3 mg | DRUG | Oral solution, single dose |
| UV-4B 10 mg | DRUG | Oral solution, single dose |
| UV-4B 30 mg | DRUG | Oral solution, single dose |
| UV-4B 90 mg | DRUG | Oral solution, single dose |
| UV-4B 180 mg | DRUG | Oral solution, single dose |
| UV-4B 360 mg | DRUG | Oral solution, single dose |
| UV-4B 720 mg | DRUG | Oral solution, single dose |
| UV-4B 1000 mg | DRUG | Oral solution, single dose |
| Placebo | DRUG | Oral solution, single dose |
Inclusion Criteria: * 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 Exclusion Criteria: * Health conditions * Taking prescription ...
UV-4B is an investigational small molecule being developed for the treatment of viral infections. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy.
UV-4B is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
UV-4B is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not received FDA approval and is not yet available for commercial use.
UV-4B has one completed clinical trial, NCT02061358, which was a Phase 1 study to determine the safety, tolerability, and pharmacokinetics of UV-4B solution administered orally in healthy subjects. The trial enrolled 64 participants in the United States and was randomized, double-blind, and controlled.
UV-4B is a distinct investigational small molecule developed by Emergent BioSolutions. It is being studied for viral infections, but no alternative names or comparisons to other approved antiviral drugs have been established in the available clinical trial information.