Viral Infection
Conditions
Keywords
Dengue, Arbovirus Infections, Flaviviridae Infections, Flavivirus Infections, Hemorrhagic Fevers, Viral, RNA Virus Infections, Virus Diseases, Pharmaceutical Solutions, Pharmacologic Actions, Therapeutic Uses
Brief 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.
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.
Interventions
DRUGUV-4B 30 mg
Oral solution, single dose
DRUGUV-4B 90 mg
Oral solution, single dose
DRUGUV-4B 180 mg
Oral solution, single dose
DRUGUV-4B 360 mg
Oral solution, single dose
DRUGUV-4B 720 mg
Oral solution, single dose
DRUGUV-4B 1000 mg
Oral solution, single dose
DRUGPlacebo
Oral solution, single dose
DRUGUV-4B 3 mg
Oral solution, single dose
DRUGUV-4B 10 mg
Oral solution, single dose
Sponsors
Quintiles, Inc.
Unither Virology
Emergent BioSolutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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 and non-prescription drugs (exceptions: acetaminophen, vitamins, hormonal birth control)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group | 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 | 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) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vz/F by Treatment Group: UV-4 | 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 is the apparent volume of distribution of UV-4 based on the terminal phase, calculated as dose (free-base equivalent) divided by \[λ(z) × AUC(0-inf)\]. |
| t(1/2) by Treatment Group: UV-4 | 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) is the apparent terminal half-life, determined as ln(2)/λ(z). |
| Cmax by Treatment Group: UV-4 | 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) | Cmax is the maximum plasma concentration, obtained directly from the observed concentration versus time data. |
| Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | 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 | 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. |
| CLr by Treatment Group: UV-4 | 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) | CLr is the renal clearance, calculated at Ae(0-last) divided by AUC(0-last). |
| Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | 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 | 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. |
| Tmax by Treatment Group: UV-4 | 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 is the time of maximum concentration observed directly from the observed concentration versus time data. |
| AUC(0-last) by Treatment Group: UV-4 | 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) 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. |
| AUC(0-inf) by Treatment Group: UV-4 | 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) 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). |
| CL/F by Treatment Group: UV-4 | 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 is the apparent systematic clearance, calculated as dose (free-base equivalent) divided by AUC(0-inf). |
Countries
United States
Participant flow
Recruitment details
This was a single center study performed in the United States. The study was completed with a total of 64 patients enrolled.
Pre-assignment details
Each cohort was assigned 6 subjects who received the cohort's prescribed dose of UV-4B, along with 2 subjects in each cohort assigned to receive placebo.
Participants by arm
| Arm | Count |
|---|---|
| 3 mg UV-4B UV-4B 3 mg oral, single dose | 6 |
| 10 mg UV-4B UV-4B 10 mg oral, single dose | 6 |
| 30 mg UV-4B UV-4B 30 mg oral, single dose | 6 |
| 90 mg UV-4B UV-4B 90 mg oral, single dose | 6 |
| 180 mg UV-4B UV-4B 180 mg oral, single dose | 6 |
| 360 mg UV-4B UV-4B 360 mg oral, single dose | 6 |
| 720 mg UV-4B UV-4B 720 mg oral, single dose | 6 |
| 1000 mg UV-4B UV-4B 1000 mg oral, single dose | 6 |
| Placebo Placebo oral, single dose | 16 |
| Total | 64 |
Baseline characteristics
| Characteristic | 3 mg UV-4B | 10 mg UV-4B | 30 mg UV-4B | 90 mg UV-4B | 180 mg UV-4B | 360 mg UV-4B | 720 mg UV-4B | 1000 mg UV-4B | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 5 | 27 years STANDARD_DEVIATION 8 | 27 years STANDARD_DEVIATION 4 | 28 years STANDARD_DEVIATION 9 | 28 years STANDARD_DEVIATION 9 | 29 years STANDARD_DEVIATION 9 | 25 years STANDARD_DEVIATION 9 | 27 years STANDARD_DEVIATION 8 | 28 years STANDARD_DEVIATION 8 | 27 years STANDARD_DEVIATION 7 |
| Body mass index | 27.44 kg/m^2 STANDARD_DEVIATION 1.28 | 26.88 kg/m^2 STANDARD_DEVIATION 2.6 | 26.44 kg/m^2 STANDARD_DEVIATION 2.36 | 24.76 kg/m^2 STANDARD_DEVIATION 2.71 | 27.05 kg/m^2 STANDARD_DEVIATION 1.84 | 26.13 kg/m^2 STANDARD_DEVIATION 2.07 | 24.86 kg/m^2 STANDARD_DEVIATION 2.93 | 24.93 kg/m^2 STANDARD_DEVIATION 1.6 | 24.89 kg/m^2 STANDARD_DEVIATION 2.82 | 25.77 kg/m^2 STANDARD_DEVIATION 2.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 6 Participants | 5 Participants | 3 Participants | 6 Participants | 6 Participants | 5 Participants | 14 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 173.4 cm STANDARD_DEVIATION 11.1 | 171.8 cm STANDARD_DEVIATION 12.3 | 175.0 cm STANDARD_DEVIATION 11.3 | 175.2 cm STANDARD_DEVIATION 3.8 | 176.2 cm STANDARD_DEVIATION 9.9 | 174.8 cm STANDARD_DEVIATION 8.9 | 172.6 cm STANDARD_DEVIATION 8.2 | 173.5 cm STANDARD_DEVIATION 3.2 | 174.9 cm STANDARD_DEVIATION 8.1 | 174.25 cm STANDARD_DEVIATION 8.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 3 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 4 Participants | 6 Participants | 14 Participants | 51 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 3 Participants | 17 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants | 5 Participants | 13 Participants | 47 Participants |
| Weight | 82.9 kg STANDARD_DEVIATION 12.1 | 79.6 kg STANDARD_DEVIATION 13.8 | 80.8 kg STANDARD_DEVIATION 9.7 | 75.9 kg STANDARD_DEVIATION 8.3 | 84.0 kg STANDARD_DEVIATION 8.5 | 80.1 kg STANDARD_DEVIATION 10.5 | 74.1 kg STANDARD_DEVIATION 11 | 75.0 kg STANDARD_DEVIATION 5.5 | 76.2 kg STANDARD_DEVIATION 11.5 | 78.36 kg STANDARD_DEVIATION 10.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 6 / 6 | 5 / 6 | 6 / 6 | 6 / 6 | 5 / 6 | 6 / 6 | 5 / 6 | 12 / 16 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 16 |
Outcome results
Primary
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.
Time frame: Day 9 ± 1
Population: Safety Population: all subjects who received any investigational product, UV-4B or placebo
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Albumin ≤ 3.3 g/dL | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | WBC ≥ 10,800 or ≤ 3,500 cell/mm^3 | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Calcium ≤ 8.8 or ≥ 10.6 mg/dL | 1 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Bilirubin ≥ 1.1 * ULN | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Aspartate aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine glucose trace or more | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lipase ≥ 1.5 * ULN | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Neutrophils ≤ 2,000 cell/mm^3 | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Amylase ≥ 1.5 * ULN | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lymphocytes ≤ 1,000 cell/mm^3 | 1 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓ | 3 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatine phosphokinase ≥ 2 * ULN | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Eosinophils ≥ 650 cell/mm^3 | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine red blood cell count ≥ 1 rbc/hpf | 2 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatinine ≥ 1.5 mg/dL | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Prothrombin time ≥ 1 * ULN | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Blood urea nitrogen ≥ 21 mg/dL | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Total protein ≤ 5.9 g/dL | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Activated partial thromboplastin time ≥ 1 * ULN | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine protein trace or more | 1 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Sodium ≤ 134 or ≥ 148 mEq/L | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Potassium ≤ 3.5 or ≥ 5.3 mEq/L | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alkaline phosphatase ≥ 2 * ULN | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Phosphorous ≤ 2.5 mg/dL | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Magnesium ≤ 1.7 mg/dL | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alanine aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatine phosphokinase ≥ 2 * ULN | 1 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatinine ≥ 1.5 mg/dL | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Potassium ≤ 3.5 or ≥ 5.3 mEq/L | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Calcium ≤ 8.8 or ≥ 10.6 mg/dL | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Activated partial thromboplastin time ≥ 1 * ULN | 1 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Eosinophils ≥ 650 cell/mm^3 | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Bilirubin ≥ 1.1 * ULN | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Blood urea nitrogen ≥ 21 mg/dL | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine protein trace or more | 1 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Aspartate aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Phosphorous ≤ 2.5 mg/dL | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | WBC ≥ 10,800 or ≤ 3,500 cell/mm^3 | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Prothrombin time ≥ 1 * ULN | 1 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓ | 5 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine glucose trace or more | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Albumin ≤ 3.3 g/dL | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lipase ≥ 1.5 * ULN | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alanine aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lymphocytes ≤ 1,000 cell/mm^3 | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Neutrophils ≤ 2,000 cell/mm^3 | 1 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Magnesium ≤ 1.7 mg/dL | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine red blood cell count ≥ 1 rbc/hpf | 4 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Total protein ≤ 5.9 g/dL | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Amylase ≥ 1.5 * ULN | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Sodium ≤ 134 or ≥ 148 mEq/L | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alkaline phosphatase ≥ 2 * ULN | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Albumin ≤ 3.3 g/dL | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine red blood cell count ≥ 1 rbc/hpf | 3 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lymphocytes ≤ 1,000 cell/mm^3 | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine glucose trace or more | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Calcium ≤ 8.8 or ≥ 10.6 mg/dL | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Potassium ≤ 3.5 or ≥ 5.3 mEq/L | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Eosinophils ≥ 650 cell/mm^3 | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Magnesium ≤ 1.7 mg/dL | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatinine ≥ 1.5 mg/dL | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Phosphorous ≤ 2.5 mg/dL | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Blood urea nitrogen ≥ 21 mg/dL | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Prothrombin time ≥ 1 * ULN | 1 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine protein trace or more | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Total protein ≤ 5.9 g/dL | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alanine aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alkaline phosphatase ≥ 2 * ULN | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Bilirubin ≥ 1.1 * ULN | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Activated partial thromboplastin time ≥ 1 * ULN | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Aspartate aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | WBC ≥ 10,800 or ≤ 3,500 cell/mm^3 | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lipase ≥ 1.5 * ULN | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Sodium ≤ 134 or ≥ 148 mEq/L | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Neutrophils ≤ 2,000 cell/mm^3 | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓ | 5 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Amylase ≥ 1.5 * ULN | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatine phosphokinase ≥ 2 * ULN | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatinine ≥ 1.5 mg/dL | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓ | 4 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | WBC ≥ 10,800 or ≤ 3,500 cell/mm^3 | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Neutrophils ≤ 2,000 cell/mm^3 | 1 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lymphocytes ≤ 1,000 cell/mm^3 | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Eosinophils ≥ 650 cell/mm^3 | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Prothrombin time ≥ 1 * ULN | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Activated partial thromboplastin time ≥ 1 * ULN | 1 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine red blood cell count ≥ 1 rbc/hpf | 3 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alkaline phosphatase ≥ 2 * ULN | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alanine aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Aspartate aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Bilirubin ≥ 1.1 * ULN | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Calcium ≤ 8.8 or ≥ 10.6 mg/dL | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Magnesium ≤ 1.7 mg/dL | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Phosphorous ≤ 2.5 mg/dL | 1 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Potassium ≤ 3.5 or ≥ 5.3 mEq/L | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Sodium ≤ 134 or ≥ 148 mEq/L | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Albumin ≤ 3.3 g/dL | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Total protein ≤ 5.9 g/dL | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Blood urea nitrogen ≥ 21 mg/dL | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatine phosphokinase ≥ 2 * ULN | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Amylase ≥ 1.5 * ULN | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lipase ≥ 1.5 * ULN | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine glucose trace or more | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine protein trace or more | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Total protein ≤ 5.9 g/dL | 1 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine glucose trace or more | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Albumin ≤ 3.3 g/dL | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Potassium ≤ 3.5 or ≥ 5.3 mEq/L | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Aspartate aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Activated partial thromboplastin time ≥ 1 * ULN | 1 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Sodium ≤ 134 or ≥ 148 mEq/L | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine red blood cell count ≥ 1 rbc/hpf | 1 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | WBC ≥ 10,800 or ≤ 3,500 cell/mm^3 | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lipase ≥ 1.5 * ULN | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Calcium ≤ 8.8 or ≥ 10.6 mg/dL | 2 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Amylase ≥ 1.5 * ULN | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Magnesium ≤ 1.7 mg/dL | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alanine aminotransferase ≥ 1.1 * ULN | 1 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Neutrophils ≤ 2,000 cell/mm^3 | 1 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatine phosphokinase ≥ 2 * ULN | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lymphocytes ≤ 1,000 cell/mm^3 | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alkaline phosphatase ≥ 2 * ULN | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine protein trace or more | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatinine ≥ 1.5 mg/dL | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Phosphorous ≤ 2.5 mg/dL | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Bilirubin ≥ 1.1 * ULN | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Eosinophils ≥ 650 cell/mm^3 | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Blood urea nitrogen ≥ 21 mg/dL | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓ | 4 Participants |
| 180 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Prothrombin time ≥ 1 * ULN | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alanine aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine glucose trace or more | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Calcium ≤ 8.8 or ≥ 10.6 mg/dL | 2 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alkaline phosphatase ≥ 2 * ULN | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Magnesium ≤ 1.7 mg/dL | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Phosphorous ≤ 2.5 mg/dL | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine red blood cell count ≥ 1 rbc/hpf | 2 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Potassium ≤ 3.5 or ≥ 5.3 mEq/L | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Sodium ≤ 134 or ≥ 148 mEq/L | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Activated partial thromboplastin time ≥ 1 * ULN | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Albumin ≤ 3.3 g/dL | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Prothrombin time ≥ 1 * ULN | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓ | 3 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Total protein ≤ 5.9 g/dL | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Blood urea nitrogen ≥ 21 mg/dL | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Eosinophils ≥ 650 cell/mm^3 | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatinine ≥ 1.5 mg/dL | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lymphocytes ≤ 1,000 cell/mm^3 | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine protein trace or more | 1 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatine phosphokinase ≥ 2 * ULN | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Neutrophils ≤ 2,000 cell/mm^3 | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Amylase ≥ 1.5 * ULN | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lipase ≥ 1.5 * ULN | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | WBC ≥ 10,800 or ≤ 3,500 cell/mm^3 | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Aspartate aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Bilirubin ≥ 1.1 * ULN | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lymphocytes ≤ 1,000 cell/mm^3 | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Amylase ≥ 1.5 * ULN | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine glucose trace or more | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine protein trace or more | 1 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine red blood cell count ≥ 1 rbc/hpf | 5 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Prothrombin time ≥ 1 * ULN | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Magnesium ≤ 1.7 mg/dL | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Calcium ≤ 8.8 or ≥ 10.6 mg/dL | 3 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Neutrophils ≤ 2,000 cell/mm^3 | 1 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Potassium ≤ 3.5 or ≥ 5.3 mEq/L | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alanine aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Aspartate aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Blood urea nitrogen ≥ 21 mg/dL | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatine phosphokinase ≥ 2 * ULN | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Total protein ≤ 5.9 g/dL | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lipase ≥ 1.5 * ULN | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Eosinophils ≥ 650 cell/mm^3 | 1 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Albumin ≤ 3.3 g/dL | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Phosphorous ≤ 2.5 mg/dL | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Bilirubin ≥ 1.1 * ULN | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Sodium ≤ 134 or ≥ 148 mEq/L | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alkaline phosphatase ≥ 2 * ULN | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatinine ≥ 1.5 mg/dL | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓ | 3 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | WBC ≥ 10,800 or ≤ 3,500 cell/mm^3 | 1 Participants |
| 720 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Activated partial thromboplastin time ≥ 1 * ULN | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lipase ≥ 1.5 * ULN | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Total protein ≤ 5.9 g/dL | 1 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine red blood cell count ≥ 1 rbc/hpf | 3 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Eosinophils ≥ 650 cell/mm^3 | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Phosphorous ≤ 2.5 mg/dL | 1 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Blood urea nitrogen ≥ 21 mg/dL | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Aspartate aminotransferase ≥ 1.1 * ULN | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine glucose trace or more | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatinine ≥ 1.5 mg/dL | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lymphocytes ≤ 1,000 cell/mm^3 | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alanine aminotransferase ≥ 1.1 * ULN | 1 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL | 1 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Neutrophils ≤ 2,000 cell/mm^3 | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Magnesium ≤ 1.7 mg/dL | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Calcium ≤ 8.8 or ≥ 10.6 mg/dL | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatine phosphokinase ≥ 2 * ULN | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Amylase ≥ 1.5 * ULN | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | WBC ≥ 10,800 or ≤ 3,500 cell/mm^3 | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine protein trace or more | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Activated partial thromboplastin time ≥ 1 * ULN | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓ | 3 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Potassium ≤ 3.5 or ≥ 5.3 mEq/L | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Bilirubin ≥ 1.1 * ULN | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Sodium ≤ 134 or ≥ 148 mEq/L | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alkaline phosphatase ≥ 2 * ULN | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Albumin ≤ 3.3 g/dL | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Prothrombin time ≥ 1 * ULN | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Albumin ≤ 3.3 g/dL | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatinine ≥ 1.5 mg/dL | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Bilirubin ≥ 1.1 * ULN | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Aspartate aminotransferase ≥ 1.1 * ULN | 1 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lymphocytes ≤ 1,000 cell/mm^3 | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Blood urea nitrogen ≥ 21 mg/dL | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Phosphorous ≤ 2.5 mg/dL | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Lipase ≥ 1.5 * ULN | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Potassium ≤ 3.5 or ≥ 5.3 mEq/L | 2 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Prothrombin time ≥ 1 * ULN | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Eosinophils ≥ 650 cell/mm^3 | 1 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Calcium ≤ 8.8 or ≥ 10.6 mg/dL | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine glucose trace or more | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Hemoglobin ≤ 11.5 (♀), 13.5 (♂) g/dL or any ↓ | 14 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Total protein ≤ 5.9 g/dL | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine protein trace or more | 1 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Creatine phosphokinase ≥ 2 * ULN | 1 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Neutrophils ≤ 2,000 cell/mm^3 | 2 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Magnesium ≤ 1.7 mg/dL | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Glucose ≤ 69 or ≥100 (fasting)/111 (random) mg/dL | 1 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Activated partial thromboplastin time ≥ 1 * ULN | 1 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Urine red blood cell count ≥ 1 rbc/hpf | 10 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alkaline phosphatase ≥ 2 * ULN | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Alanine aminotransferase ≥ 1.1 * ULN | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Sodium ≤ 134 or ≥ 148 mEq/L | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | Amylase ≥ 1.5 * ULN | 0 Participants |
| Placebo | Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group | WBC ≥ 10,800 or ≤ 3,500 cell/mm^3 | 1 Participants |
Primary
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
Time frame: From time of the first dose administration through Day 9 ± 1
Population: Safety Population: all subjects who received any investigational product, UV-4B or placebo
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 220 ms | 0 participants |
| 3 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QRS > 120 ms | 0 participants |
| 3 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 450 ms (males) or > 470 ms (females) | 0 participants |
| 3 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | Subjects with an outlier value | 0 participants |
| 3 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 30 ms or ≤ 60 ms | 0 participants |
| 3 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 500 ms | 0 participants |
| 3 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | PR > 220 ms | 0 participants |
| 10 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 30 ms or ≤ 60 ms | 0 participants |
| 10 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | Subjects with an outlier value | 0 participants |
| 10 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QRS > 120 ms | 0 participants |
| 10 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 450 ms (males) or > 470 ms (females) | 0 participants |
| 10 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | PR > 220 ms | 0 participants |
| 10 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 500 ms | 0 participants |
| 10 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 220 ms | 0 participants |
| 30 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QRS > 120 ms | 0 participants |
| 30 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | PR > 220 ms | 0 participants |
| 30 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 30 ms or ≤ 60 ms | 0 participants |
| 30 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 220 ms | 0 participants |
| 30 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 450 ms (males) or > 470 ms (females) | 0 participants |
| 30 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 500 ms | 0 participants |
| 30 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | Subjects with an outlier value | 0 participants |
| 90 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 500 ms | 0 participants |
| 90 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QRS > 120 ms | 0 participants |
| 90 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 30 ms or ≤ 60 ms | 0 participants |
| 90 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | PR > 220 ms | 0 participants |
| 90 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | Subjects with an outlier value | 0 participants |
| 90 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 220 ms | 0 participants |
| 90 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 450 ms (males) or > 470 ms (females) | 0 participants |
| 180 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 30 ms or ≤ 60 ms | 0 participants |
| 180 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | Subjects with an outlier value | 0 participants |
| 180 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 450 ms (males) or > 470 ms (females) | 0 participants |
| 180 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 500 ms | 0 participants |
| 180 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 220 ms | 0 participants |
| 180 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | PR > 220 ms | 0 participants |
| 180 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QRS > 120 ms | 0 participants |
| 360 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 500 ms | 0 participants |
| 360 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | PR > 220 ms | 0 participants |
| 360 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | Subjects with an outlier value | 0 participants |
| 360 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 220 ms | 0 participants |
| 360 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 30 ms or ≤ 60 ms | 0 participants |
| 360 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QRS > 120 ms | 0 participants |
| 360 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 450 ms (males) or > 470 ms (females) | 0 participants |
| 720 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 220 ms | 0 participants |
| 720 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 30 ms or ≤ 60 ms | 0 participants |
| 720 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | PR > 220 ms | 0 participants |
| 720 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QRS > 120 ms | 0 participants |
| 720 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 500 ms | 0 participants |
| 720 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | Subjects with an outlier value | 0 participants |
| 720 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 450 ms (males) or > 470 ms (females) | 0 participants |
| 1000 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 30 ms or ≤ 60 ms | 0 participants |
| 1000 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 500 ms | 0 participants |
| 1000 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 220 ms | 0 participants |
| 1000 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 450 ms (males) or > 470 ms (females) | 0 participants |
| 1000 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QRS > 120 ms | 0 participants |
| 1000 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | PR > 220 ms | 0 participants |
| 1000 mg UV-4B | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | Subjects with an outlier value | 0 participants |
| Placebo | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | Subjects with an outlier value | 0 participants |
| Placebo | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | PR > 220 ms | 0 participants |
| Placebo | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QRS > 120 ms | 0 participants |
| Placebo | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 450 ms (males) or > 470 ms (females) | 0 participants |
| Placebo | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 220 ms | 0 participants |
| Placebo | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF > 500 ms | 0 participants |
| Placebo | Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group | QTcF increase from baseline > 30 ms or ≤ 60 ms | 0 participants |
Primary
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
Time frame: From time of the first dose administration through Day 9 ± 1
Population: Safety Population: all subjects who received any investigational product, UV-4B or placebo
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine diastolic BP ≥ 91 mmHg | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm) | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Temperature ≥ 100.4 ⁰F (38.0 ⁰C) | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≥ 141 mmHg | 1 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≤ 89 mmHg | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing diastolic BP ≥ 91 mmHg | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Respiratory rate ≥ 17 breaths/min | 3 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≥ 141 mmHg | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≥ 101 bpm | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≥ 101 bpm | 6 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≤ 89 mmHg | 0 Participants |
| 3 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Subjects with any Grade 1 or higher | 6 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm | 3 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Subjects with any Grade 1 or higher | 6 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Respiratory rate ≥ 17 breaths/min | 4 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Temperature ≥ 100.4 ⁰F (38.0 ⁰C) | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≥ 101 bpm | 6 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≥ 141 mmHg | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≥ 141 mmHg | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm) | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≤ 89 mmHg | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≤ 89 mmHg | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing diastolic BP ≥ 91 mmHg | 1 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≥ 101 bpm | 0 Participants |
| 10 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine diastolic BP ≥ 91 mmHg | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 54 bpm, baseline > 60 bpm | 1 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm | 1 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≤ 89 mmHg | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Subjects with any Grade 1 or higher | 5 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Respiratory rate ≥ 17 breaths/min | 1 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≥ 141 mmHg | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≥ 101 bpm | 2 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≤ 89 mmHg | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≥ 141 mmHg | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm) | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine diastolic BP ≥ 91 mmHg | 1 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Temperature ≥ 100.4 ⁰F (38.0 ⁰C) | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≥ 101 bpm | 0 Participants |
| 30 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing diastolic BP ≥ 91 mmHg | 1 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≤ 89 mmHg | 1 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≥ 101 bpm | 3 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 54 bpm, baseline > 60 bpm | 1 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine diastolic BP ≥ 91 mmHg | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing diastolic BP ≥ 91 mmHg | 2 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≥ 101 bpm | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm | 2 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Subjects with any Grade 1 or higher | 5 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≥ 141 mmHg | 1 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Respiratory rate ≥ 17 breaths/min | 2 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Temperature ≥ 100.4 ⁰F (38.0 ⁰C) | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm) | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≤ 89 mmHg | 0 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≥ 141 mmHg | 2 Participants |
| 90 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 54 bpm, baseline > 60 bpm | 1 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm | 1 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Subjects with any Grade 1 or higher | 6 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≤ 89 mmHg | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≥ 141 mmHg | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≤ 89 mmHg | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≥ 141 mmHg | 2 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine diastolic BP ≥ 91 mmHg | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing diastolic BP ≥ 91 mmHg | 2 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 54 bpm, baseline > 60 bpm | 2 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≥ 101 bpm | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm) | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≥ 101 bpm | 5 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Respiratory rate ≥ 17 breaths/min | 3 Participants |
| 180 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Temperature ≥ 100.4 ⁰F (38.0 ⁰C) | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Temperature ≥ 100.4 ⁰F (38.0 ⁰C) | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm | 1 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≥ 141 mmHg | 2 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≤ 89 mmHg | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm) | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Respiratory rate ≥ 17 breaths/min | 1 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≤ 89 mmHg | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine diastolic BP ≥ 91 mmHg | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Subjects with any Grade 1 or higher | 5 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≥ 101 bpm | 0 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing diastolic BP ≥ 91 mmHg | 2 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≥ 101 bpm | 4 Participants |
| 360 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≥ 141 mmHg | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing diastolic BP ≥ 91 mmHg | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Subjects with any Grade 1 or higher | 6 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine diastolic BP ≥ 91 mmHg | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≥ 101 bpm | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≥ 141 mmHg | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm) | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≤ 89 mmHg | 1 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≥ 141 mmHg | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Temperature ≥ 100.4 ⁰F (38.0 ⁰C) | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≥ 101 bpm | 6 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≤ 89 mmHg | 0 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Respiratory rate ≥ 17 breaths/min | 3 Participants |
| 720 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm | 1 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine diastolic BP ≥ 91 mmHg | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Temperature ≥ 100.4 ⁰F (38.0 ⁰C) | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≥ 101 bpm | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing diastolic BP ≥ 91 mmHg | 1 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Respiratory rate ≥ 17 breaths/min | 2 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≥ 141 mmHg | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≥ 101 bpm | 4 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm) | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 54 bpm, baseline > 60 bpm | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≤ 89 mmHg | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Subjects with any Grade 1 or higher | 6 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≤ 89 mmHg | 0 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≥ 141 mmHg | 1 Participants |
| 1000 mg UV-4B | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm | 3 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≥ 141 mmHg | 1 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 54 bpm, baseline > 60 bpm | 1 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≥ 141 mmHg | 1 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≥ 101 bpm | 1 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 50 bpm, baseline ≤ 60 bpm | 4 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≥ 101 bpm | 9 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine systolic BP ≤ 89 mmHg | 2 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing diastolic BP ≥ 91 mmHg | 3 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine diastolic BP ≥ 91 mmHg | 0 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Respiratory rate ≥ 17 breaths/min | 5 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Subjects with any Grade 1 or higher | 12 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing pulse ≤ 50 bpm, baseline ≤ 60 bpm) | 0 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Standing systolic BP ≤ 89 mmHg | 1 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Temperature ≥ 100.4 ⁰F (38.0 ⁰C) | 0 Participants |
| Placebo | Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) | Supine pulse ≤ 54 bpm, baseline > 60 bpm | 1 Participants |
Primary
Subjects With Serious Adverse Event (SAEs) by Treatment Group
Subjects with AEs considered serious by the investigator
Time frame: From time of the first dose administration through Day 9 ± 1
Population: Safety Population: all subjects who received any investigational product, UV-4B or placebo
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 mg UV-4B | Subjects With Serious Adverse Event (SAEs) by Treatment Group | 0 Subjects with at least 1 SAE |
| 10 mg UV-4B | Subjects With Serious Adverse Event (SAEs) by Treatment Group | 0 Subjects with at least 1 SAE |
| 30 mg UV-4B | Subjects With Serious Adverse Event (SAEs) by Treatment Group | 0 Subjects with at least 1 SAE |
| 90 mg UV-4B | Subjects With Serious Adverse Event (SAEs) by Treatment Group | 0 Subjects with at least 1 SAE |
| 180 mg UV-4B | Subjects With Serious Adverse Event (SAEs) by Treatment Group | 0 Subjects with at least 1 SAE |
| 360 mg UV-4B | Subjects With Serious Adverse Event (SAEs) by Treatment Group | 0 Subjects with at least 1 SAE |
| 720 mg UV-4B | Subjects With Serious Adverse Event (SAEs) by Treatment Group | 0 Subjects with at least 1 SAE |
| 1000 mg UV-4B | Subjects With Serious Adverse Event (SAEs) by Treatment Group | 0 Subjects with at least 1 SAE |
| Placebo | Subjects With Serious Adverse Event (SAEs) by Treatment Group | 0 Subjects with at least 1 SAE |
Primary
Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group
TEAEs are those AEs occurring only after administration of investigational product
Time frame: From time of the first dose administration through Day 9 ± 1
Population: Safety Population: all subjects who received any investigational product, UV-4B or placebo
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 mg UV-4B | Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group | 5 Subjects with at least 1 TEAE |
| 10 mg UV-4B | Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group | 6 Subjects with at least 1 TEAE |
| 30 mg UV-4B | Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group | 5 Subjects with at least 1 TEAE |
| 90 mg UV-4B | Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group | 5 Subjects with at least 1 TEAE |
| 180 mg UV-4B | Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group | 6 Subjects with at least 1 TEAE |
| 360 mg UV-4B | Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group | 5 Subjects with at least 1 TEAE |
| 720 mg UV-4B | Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group | 6 Subjects with at least 1 TEAE |
| 1000 mg UV-4B | Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group | 5 Subjects with at least 1 TEAE |
| Placebo | Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group | 12 Subjects with at least 1 TEAE |
Secondary
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).
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)
Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg UV-4B | AUC(0-inf) by Treatment Group: UV-4 | 94.6 ng * h/mL | Geometric Coefficient of Variation 16.3 |
| 10 mg UV-4B | AUC(0-inf) by Treatment Group: UV-4 | 420 ng * h/mL | Geometric Coefficient of Variation 24.2 |
| 30 mg UV-4B | AUC(0-inf) by Treatment Group: UV-4 | 1260 ng * h/mL | Geometric Coefficient of Variation 10.2 |
| 90 mg UV-4B | AUC(0-inf) by Treatment Group: UV-4 | 3700 ng * h/mL | Geometric Coefficient of Variation 13.3 |
| 180 mg UV-4B | AUC(0-inf) by Treatment Group: UV-4 | 7090 ng * h/mL | Geometric Coefficient of Variation 8.2 |
| 360 mg UV-4B | AUC(0-inf) by Treatment Group: UV-4 | 13700 ng * h/mL | Geometric Coefficient of Variation 14.6 |
| 720 mg UV-4B | AUC(0-inf) by Treatment Group: UV-4 | 32800 ng * h/mL | Geometric Coefficient of Variation 10.9 |
| 1000 mg UV-4B | AUC(0-inf) by Treatment Group: UV-4 | 42800 ng * h/mL | Geometric Coefficient of Variation 13.3 |
Secondary
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.
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)
Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg UV-4B | AUC(0-last) by Treatment Group: UV-4 | 82.1 ng * h/mL | Geometric Coefficient of Variation 18.8 |
| 10 mg UV-4B | AUC(0-last) by Treatment Group: UV-4 | 406 ng * h/mL | Geometric Coefficient of Variation 24.7 |
| 30 mg UV-4B | AUC(0-last) by Treatment Group: UV-4 | 1230 ng * h/mL | Geometric Coefficient of Variation 10.9 |
| 90 mg UV-4B | AUC(0-last) by Treatment Group: UV-4 | 3640 ng * h/mL | Geometric Coefficient of Variation 12.7 |
| 180 mg UV-4B | AUC(0-last) by Treatment Group: UV-4 | 7050 ng * h/mL | Geometric Coefficient of Variation 8.3 |
| 360 mg UV-4B | AUC(0-last) by Treatment Group: UV-4 | 13600 ng * h/mL | Geometric Coefficient of Variation 14.6 |
| 720 mg UV-4B | AUC(0-last) by Treatment Group: UV-4 | 32700 ng * h/mL | Geometric Coefficient of Variation 10.9 |
| 1000 mg UV-4B | AUC(0-last) by Treatment Group: UV-4 | 42700 ng * h/mL | Geometric Coefficient of Variation 13.2 |
Secondary
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).
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)
Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg UV-4B | CL/F by Treatment Group: UV-4 | 31.7 L/h | Geometric Coefficient of Variation 16.3 |
| 10 mg UV-4B | CL/F by Treatment Group: UV-4 | 23.8 L/h | Geometric Coefficient of Variation 24.1 |
| 30 mg UV-4B | CL/F by Treatment Group: UV-4 | 23.9 L/h | Geometric Coefficient of Variation 10.5 |
| 90 mg UV-4B | CL/F by Treatment Group: UV-4 | 24.3 L/h | Geometric Coefficient of Variation 13.5 |
| 180 mg UV-4B | CL/F by Treatment Group: UV-4 | 25.4 L/h | Geometric Coefficient of Variation 8.2 |
| 360 mg UV-4B | CL/F by Treatment Group: UV-4 | 26.3 L/h | Geometric Coefficient of Variation 14.7 |
| 720 mg UV-4B | CL/F by Treatment Group: UV-4 | 22.0 L/h | Geometric Coefficient of Variation 11 |
| 1000 mg UV-4B | CL/F by Treatment Group: UV-4 | 23.4 L/h | Geometric Coefficient of Variation 13.3 |
Secondary
CLr by Treatment Group: UV-4
CLr is the renal clearance, calculated at Ae(0-last) divided by AUC(0-last).
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)
Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing.L/h
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg UV-4B | CLr by Treatment Group: UV-4 | 14.3 L/h | Geometric Coefficient of Variation 15 |
| 10 mg UV-4B | CLr by Treatment Group: UV-4 | 11.4 L/h | Geometric Coefficient of Variation 26.9 |
| 30 mg UV-4B | CLr by Treatment Group: UV-4 | 12.5 L/h | Geometric Coefficient of Variation 10.1 |
| 90 mg UV-4B | CLr by Treatment Group: UV-4 | 13.6 L/h | Geometric Coefficient of Variation 14.2 |
| 180 mg UV-4B | CLr by Treatment Group: UV-4 | 13.9 L/h | Geometric Coefficient of Variation 12.4 |
| 360 mg UV-4B | CLr by Treatment Group: UV-4 | 13.7 L/h | Geometric Coefficient of Variation 23.6 |
| 720 mg UV-4B | CLr by Treatment Group: UV-4 | 10.9 L/h | Geometric Coefficient of Variation 17.6 |
| 1000 mg UV-4B | CLr by Treatment Group: UV-4 | 11.7 L/h | Geometric Coefficient of Variation 17.2 |
Secondary
Cmax by Treatment Group: UV-4
Cmax is the maximum plasma concentration, obtained directly from the observed concentration versus time data.
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)
Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg UV-4B | Cmax by Treatment Group: UV-4 | 22.1 ng/mL | Geometric Coefficient of Variation 15.4 |
| 10 mg UV-4B | Cmax by Treatment Group: UV-4 | 82.6 ng/mL | Geometric Coefficient of Variation 24.2 |
| 30 mg UV-4B | Cmax by Treatment Group: UV-4 | 289 ng/mL | Geometric Coefficient of Variation 17.5 |
| 90 mg UV-4B | Cmax by Treatment Group: UV-4 | 900 ng/mL | Geometric Coefficient of Variation 35.3 |
| 180 mg UV-4B | Cmax by Treatment Group: UV-4 | 2060 ng/mL | Geometric Coefficient of Variation 33.6 |
| 360 mg UV-4B | Cmax by Treatment Group: UV-4 | 4490 ng/mL | Geometric Coefficient of Variation 20 |
| 720 mg UV-4B | Cmax by Treatment Group: UV-4 | 9760 ng/mL | Geometric Coefficient of Variation 20 |
| 1000 mg UV-4B | Cmax by Treatment Group: UV-4 | 13000 ng/mL | Geometric Coefficient of Variation 15.6 |
Secondary
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.
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
Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-12) | 0.822 mg | Standard Deviation 0.177 |
| 3 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-24) | 1.02 mg | Standard Deviation 0.197 |
| 3 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(12-24) | 0.202 mg | Standard Deviation 0.0543 |
| 3 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-6) | 0.607 mg | Standard Deviation 0.145 |
| 3 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(6-12) | 0.215 mg | Standard Deviation 0.0496 |
| 3 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(24-48) | 0.170 mg | Standard Deviation 0.0416 |
| 3 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-last) | 1.19 mg | Standard Deviation 0.2 |
| 10 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-last) | 4.64 mg | Standard Deviation 0.463 |
| 10 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-12) | 3.53 mg | Standard Deviation 0.428 |
| 10 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(6-12) | 0.859 mg | Standard Deviation 0.112 |
| 10 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(12-24) | 0.608 mg | Standard Deviation 0.0888 |
| 10 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(24-48) | 0.503 mg | Standard Deviation 0.0655 |
| 10 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-6) | 2.67 mg | Standard Deviation 0.386 |
| 10 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-24) | 4.13 mg | Standard Deviation 0.515 |
| 30 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-12) | 13.0 mg | Standard Deviation 1.31 |
| 30 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-last) | 15.5 mg | Standard Deviation 0.982 |
| 30 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(24-48) | 0.887 mg | Standard Deviation 0.2 |
| 30 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(6-12) | 2.45 mg | Standard Deviation 0.145 |
| 30 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-6) | 10.6 mg | Standard Deviation 1.18 |
| 30 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-24) | 14.6 mg | Standard Deviation 1.13 |
| 30 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(12-24) | 1.61 mg | Standard Deviation 0.363 |
| 90 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(24-48) | 1.61 mg | Standard Deviation 0.474 |
| 90 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-last) | 49.6 mg | Standard Deviation 3.58 |
| 90 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(6-12) | 6.05 mg | Standard Deviation 2.55 |
| 90 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-24) | 48.0 mg | Standard Deviation 3.75 |
| 90 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(12-24) | 3.89 mg | Standard Deviation 0.799 |
| 90 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-6) | 38.1 mg | Standard Deviation 3.83 |
| 90 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-12) | 44.1 mg | Standard Deviation 3.83 |
| 180 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(24-48) | 2.43 mg | Standard Deviation 1.03 |
| 180 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-6) | 77.5 mg | Standard Deviation 3.49 |
| 180 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(6-12) | 12.1 mg | Standard Deviation 1.48 |
| 180 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(12-24) | 6.06 mg | Standard Deviation 2.4 |
| 180 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-12) | 89.6 mg | Standard Deviation 3.76 |
| 180 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-24) | 95.7 mg | Standard Deviation 4.26 |
| 180 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-last) | 97.9 mg | Standard Deviation 4.86 |
| 360 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(24-48) | 2.83 mg | Standard Deviation 0.672 |
| 360 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-last) | 188 mg | Standard Deviation 17.3 |
| 360 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-12) | 178 mg | Standard Deviation 18.7 |
| 360 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(12-24) | 7.09 mg | Standard Deviation 1.9 |
| 360 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-24) | 185 mg | Standard Deviation 17.9 |
| 360 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(6-12) | 19.1 mg | Standard Deviation 7 |
| 360 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-6) | 159 mg | Standard Deviation 24.3 |
| 720 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(6-12) | 42.5 mg | Standard Deviation 6 |
| 720 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-6) | 301 mg | Standard Deviation 36.3 |
| 720 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-24) | 355 mg | Standard Deviation 34.6 |
| 720 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-12) | 355 mg | Standard Deviation 34.6 |
| 720 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-last) | 360 mg | Standard Deviation 34.7 |
| 720 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(12-24) | 11.7 mg | Standard Deviation 1.6 |
| 720 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(24-48) | 4.09 mg | Standard Deviation 1.24 |
| 1000 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-last) | 504 mg | Standard Deviation 66.1 |
| 1000 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(24-48) | 5.21 mg | Standard Deviation 1.41 |
| 1000 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-24) | 498 mg | Standard Deviation 65.6 |
| 1000 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-6) | 428 mg | Standard Deviation 64.5 |
| 1000 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(12-24) | 16.4 mg | Standard Deviation 5.32 |
| 1000 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(0-12) | 498 mg | Standard Deviation 65.6 |
| 1000 mg UV-4B | Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group | Ae(6-12) | 53.7 mg | Standard Deviation 15.2 |
Secondary
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.
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
Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-12) | 27.4 percentage of dose | Standard Deviation 5.93 |
| 3 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-24) | 34.1 percentage of dose | Standard Deviation 6.57 |
| 3 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(12-24) | 6.71 percentage of dose | Standard Deviation 1.82 |
| 3 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-6) | 20.2 percentage of dose | Standard Deviation 4.81 |
| 3 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(6-12) | 7.17 percentage of dose | Standard Deviation 1.65 |
| 3 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(24-48) | 5.66 percentage of dose | Standard Deviation 1.39 |
| 3 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-last) | 39.8 percentage of dose | Standard Deviation 6.66 |
| 10 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-last) | 46.4 percentage of dose | Standard Deviation 4.63 |
| 10 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-12) | 35.3 percentage of dose | Standard Deviation 4.28 |
| 10 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(6-12) | 8.59 percentage of dose | Standard Deviation 1.12 |
| 10 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(12-24) | 6.08 percentage of dose | Standard Deviation 0.888 |
| 10 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(24-48) | 5.03 percentage of dose | Standard Deviation 0.655 |
| 10 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-6) | 26.7 percentage of dose | Standard Deviation 3.86 |
| 10 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-24) | 41.3 percentage of dose | Standard Deviation 5.15 |
| 30 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-12) | 43.4 percentage of dose | Standard Deviation 4.28 |
| 30 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-last) | 51.7 percentage of dose | Standard Deviation 3.27 |
| 30 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(24-48) | 2.96 percentage of dose | Standard Deviation 0.664 |
| 30 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(6-12) | 8.16 percentage of dose | Standard Deviation 0.48 |
| 30 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-6) | 35.3 percentage of dose | Standard Deviation 3.84 |
| 30 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-24) | 48.8 percentage of dose | Standard Deviation 3.72 |
| 30 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(12-24) | 5.36 percentage of dose | Standard Deviation 1.21 |
| 90 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(24-48) | 1.79 percentage of dose | Standard Deviation 0.528 |
| 90 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-last) | 55.1 percentage of dose | Standard Deviation 3.98 |
| 90 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(6-12) | 6.72 percentage of dose | Standard Deviation 2.83 |
| 90 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-24) | 53.3 percentage of dose | Standard Deviation 4.14 |
| 90 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(12-24) | 4.32 percentage of dose | Standard Deviation 0.886 |
| 90 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-6) | 42.2 percentage of dose | Standard Deviation 4.26 |
| 90 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-12) | 49.0 percentage of dose | Standard Deviation 4.28 |
| 180 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(24-48) | 1.35 percentage of dose | Standard Deviation 0.572 |
| 180 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-6) | 43.0 percentage of dose | Standard Deviation 1.96 |
| 180 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(6-12) | 6.74 percentage of dose | Standard Deviation 0.82 |
| 180 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(12-24) | 3.37 percentage of dose | Standard Deviation 1.34 |
| 180 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-12) | 49.8 percentage of dose | Standard Deviation 2.08 |
| 180 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-24) | 53.1 percentage of dose | Standard Deviation 2.37 |
| 180 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-last) | 54.5 percentage of dose | Standard Deviation 2.76 |
| 360 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(24-48) | 0.787 percentage of dose | Standard Deviation 0.186 |
| 360 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-last) | 52.3 percentage of dose | Standard Deviation 4.82 |
| 360 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-12) | 49.5 percentage of dose | Standard Deviation 5.18 |
| 360 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(12-24) | 1.97 percentage of dose | Standard Deviation 0.532 |
| 360 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-24) | 51.5 percentage of dose | Standard Deviation 4.97 |
| 360 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(6-12) | 5.32 percentage of dose | Standard Deviation 1.94 |
| 360 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-6) | 44.2 percentage of dose | Standard Deviation 6.69 |
| 720 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(6-12) | 5.90 percentage of dose | Standard Deviation 0.833 |
| 720 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-6) | 41.8 percentage of dose | Standard Deviation 5.04 |
| 720 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-24) | 49.4 percentage of dose | Standard Deviation 4.81 |
| 720 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-12) | 47.7 percentage of dose | Standard Deviation 4.86 |
| 720 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-last) | 49.9 percentage of dose | Standard Deviation 4.84 |
| 720 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(12-24) | 1.63 percentage of dose | Standard Deviation 0.221 |
| 720 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(24-48) | 0.569 percentage of dose | Standard Deviation 0.172 |
| 1000 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-last) | 50.4 percentage of dose | Standard Deviation 6.61 |
| 1000 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(24-48) | 0.521 percentage of dose | Standard Deviation 0.141 |
| 1000 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-24) | 49.8 percentage of dose | Standard Deviation 6.56 |
| 1000 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-6) | 42.8 percentage of dose | Standard Deviation 6.45 |
| 1000 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(12-24) | 1.64 percentage of dose | Standard Deviation 0.532 |
| 1000 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(0-12) | 48.2 percentage of dose | Standard Deviation 6.66 |
| 1000 mg UV-4B | Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group | fe(6-12) | 5.37 percentage of dose | Standard Deviation 1.52 |
Secondary
t(1/2) by Treatment Group: UV-4
t(1/2) is the apparent terminal half-life, determined as ln(2)/λ(z).
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)
Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 3 mg UV-4B | t(1/2) by Treatment Group: UV-4 | 9.11 hours |
| 10 mg UV-4B | t(1/2) by Treatment Group: UV-4 | 11.6 hours |
| 30 mg UV-4B | t(1/2) by Treatment Group: UV-4 | 9.98 hours |
| 90 mg UV-4B | t(1/2) by Treatment Group: UV-4 | 9.56 hours |
| 180 mg UV-4B | t(1/2) by Treatment Group: UV-4 | 8.52 hours |
| 360 mg UV-4B | t(1/2) by Treatment Group: UV-4 | 8.14 hours |
| 720 mg UV-4B | t(1/2) by Treatment Group: UV-4 | 8.03 hours |
| 1000 mg UV-4B | t(1/2) by Treatment Group: UV-4 | 7.95 hours |
Secondary
Tmax by Treatment Group: UV-4
Tmax is the time of maximum concentration observed directly from the observed concentration versus time data.
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)
Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 3 mg UV-4B | Tmax by Treatment Group: UV-4 | 0.50 hours |
| 10 mg UV-4B | Tmax by Treatment Group: UV-4 | 1.00 hours |
| 30 mg UV-4B | Tmax by Treatment Group: UV-4 | 0.50 hours |
| 90 mg UV-4B | Tmax by Treatment Group: UV-4 | 0.50 hours |
| 180 mg UV-4B | Tmax by Treatment Group: UV-4 | 0.75 hours |
| 360 mg UV-4B | Tmax by Treatment Group: UV-4 | 0.50 hours |
| 720 mg UV-4B | Tmax by Treatment Group: UV-4 | 0.75 hours |
| 1000 mg UV-4B | Tmax by Treatment Group: UV-4 | 1.00 hours |
Secondary
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 \[λ(z) × AUC(0-inf)\].
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)
Population: The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg UV-4B | Vz/F by Treatment Group: UV-4 | 470 L | Geometric Coefficient of Variation 32.8 |
| 10 mg UV-4B | Vz/F by Treatment Group: UV-4 | 409 L | Geometric Coefficient of Variation 30.6 |
| 30 mg UV-4B | Vz/F by Treatment Group: UV-4 | 344 L | Geometric Coefficient of Variation 16.7 |
| 90 mg UV-4B | Vz/F by Treatment Group: UV-4 | 358 L | Geometric Coefficient of Variation 21.5 |
| 180 mg UV-4B | Vz/F by Treatment Group: UV-4 | 317 L | Geometric Coefficient of Variation 17.2 |
| 360 mg UV-4B | Vz/F by Treatment Group: UV-4 | 308 L | Geometric Coefficient of Variation 11.9 |
| 720 mg UV-4B | Vz/F by Treatment Group: UV-4 | 259 L | Geometric Coefficient of Variation 10.3 |
| 1000 mg UV-4B | Vz/F by Treatment Group: UV-4 | 290 L | Geometric Coefficient of Variation 27.3 |