Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02061358 | Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects | PHASE1 | COMPLETED | 64 | — | — | Jul 1, 2014 | Sep 1, 2015 | Mar 18, 2024 | 1 | United States |
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 ...