Trial Outcomes & Findings for Safety Study of SLV213 for the Treatment of COVID-19. (NCT NCT06146374)
NCT ID: NCT06146374
Last Updated: 2025-07-22
Results Overview
The number of participants who experienced at least one unsolicited TEAE of any relatedness are summarized by the maximum severity recorded. A TEAE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. A TEAE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as a TEAE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as a TEAE.
TERMINATED
PHASE1
16 participants
Day 1 through Day 28
2025-07-22
Participant Flow
The study population included healthy male and female adults, ages 18-65, inclusive, who met all eligibility criteria. Participants were enrolled at a single clinical trial unit between April 9, 2024 and June 10, 2024 and were recruited via IRB-approved strategies, including direct mailing, recruitment from an IRB-approved trial registry and local advertisements/flyers.
Participant milestones
| Measure |
Cohort 1 - 400 mg SLV213
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
SLV213: SLV213 drug substance (K777) is 4-methylpiperazine-1-carboxylic acid, a vinyl sulfone cysteine protease inhibitor for the treatment of participants infected with SARS-CoV-2. SLV213 is a white powder substance without excipients or stabilizer that was packed into gelatin capsules. SLV213 has been demonstrated to exhibit broad inhibitory properties against host cathepsins (e.g., Cathepsin L).
|
Cohort 2 - 600 mg SLV213
600 mg (6 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
SLV213: SLV213 drug substance (K777) is 4-methylpiperazine-1-carboxylic acid, a vinyl sulfone cysteine protease inhibitor for the treatment of participants infected with SARS-CoV-2. SLV213 is a white powder substance without excipients or stabilizer that was packed into gelatin capsules. SLV213 has been demonstrated to exhibit broad inhibitory properties against host cathepsins (e.g., Cathepsin L).
The study was terminated early due to halting criteria being met in Cohort 1, so this Cohort was not enrolled.
|
Cohort 3 - 800 mg SLV213
800 mg (8 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
SLV213: SLV213 drug substance (K777) is 4-methylpiperazine-1-carboxylic acid, a vinyl sulfone cysteine protease inhibitor for the treatment of participants infected with SARS-CoV-2. SLV213 is a white powder substance without excipients or stabilizer that was packed into gelatin capsules. SLV213 has been demonstrated to exhibit broad inhibitory properties against host cathepsins (e.g., Cathepsin L).
The study was terminated early due to halting criteria being met in Cohort 1, so this Cohort was not enrolled.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
Placebo for SLV213: Microcrystalline cellulose in a size 1 orange hard gelatin capsule.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
0
|
0
|
5
|
|
Overall Study
COMPLETED
|
11
|
0
|
0
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of SLV213 for the Treatment of COVID-19.
Baseline characteristics by cohort
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.51 kg/m^2
STANDARD_DEVIATION 3.33 • n=5 Participants
|
27.70 kg/m^2
STANDARD_DEVIATION 4.41 • n=7 Participants
|
27.57 kg/m^2
STANDARD_DEVIATION 3.55 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one unsolicited TEAE of any relatedness are summarized by the maximum severity recorded. A TEAE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. A TEAE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as a TEAE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as a TEAE.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by Maximum Severity
None
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by Maximum Severity
Mild
|
7 Participants
|
3 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by Maximum Severity
Moderate
|
4 Participants
|
2 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by Maximum Severity
Severe
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one related unsolicited TEAE of any severity. A TEAE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. A TEAE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as a TEAE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as a TEAE. A TEAE is considered related if there is a reasonable possibility that the study intervention caused the TEAE, or there is a temporal relationship between the study intervention and event.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Related Treatment-Related TEAEs
|
11 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one SAE throughout the course of the study. An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening adverse event * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or * A congenital anomaly/birth defect.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one laboratory AE of any relatedness are summarized by the maximum severity recorded. Graded chemistry measurements include sodium, potassium, carbon dioxide, calcium, creatinine, blood urea nitrogen, fasting glucose, total protein, albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, amylase, lipase, magnesium, and inorganic phosphorous. Graded hematology measurements include hemoglobin, platelets, white blood cells, neutrophils, lymphocytes, monocytes, basophils, and eosinophils. Graded coagulation measurements include prothrombin time and activated partial thromboplastin time. Graded urinalysis measurements include nitrite, urine protein, urine glucose, white blood cells, red blood cells, and bacteria. If a laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Laboratory AEs by Maximum Severity
None
|
0 Participants
|
0 Participants
|
|
Frequency of Laboratory AEs by Maximum Severity
Mild
|
10 Participants
|
4 Participants
|
|
Frequency of Laboratory AEs by Maximum Severity
Moderate
|
0 Participants
|
1 Participants
|
|
Frequency of Laboratory AEs by Maximum Severity
Severe
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one related laboratory AE of any severity. Graded chemistry measurements include sodium, potassium, carbon dioxide, calcium, creatinine, blood urea nitrogen, fasting glucose, total protein, albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, amylase, lipase, magnesium, and inorganic phosphorous. Graded hematology measurements include hemoglobin, platelets, white blood cells, neutrophils, lymphocytes, monocytes, basophils, and eosinophils. Graded coagulation measurements include prothrombin time and activated partial thromboplastin time. Graded urinalysis measurements include nitrite, urine protein, urine glucose, white blood cells, red blood cells, and bacteria. If a laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Treatment-Related Laboratory AEs
|
11 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one ECG AE of any relatedness are summarized by the maximum severity recorded. Graded ECG parameters include PR Internal and QTcF Interval.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Electrocardiogram (ECG) AEs by Maximum Severity
None
|
11 Participants
|
4 Participants
|
|
Frequency of Electrocardiogram (ECG) AEs by Maximum Severity
Mild
|
0 Participants
|
1 Participants
|
|
Frequency of Electrocardiogram (ECG) AEs by Maximum Severity
Moderate
|
0 Participants
|
0 Participants
|
|
Frequency of Electrocardiogram (ECG) AEs by Maximum Severity
Severe
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one related ECG AE of any severity. Graded ECG parameters include PR Internal and QTcF Interval.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Treatment-Related ECG AEs
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who terminated early or were withdrawn due to a treatment-related TEAE. This outcome is used to assess the tolerability of the study treatment.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Early Terminations or Withdrawals Due to Treatment-Related TEAEs
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one TEAE of any severity. This outcome is used to assess the tolerability of the study treatment.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of TEAEs
|
11 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one Grade 3 (severe) or higher laboratory AE. This outcome is used to assess the tolerability of the study treatment.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Grade 3 or Higher Laboratory AEs
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one Grade 3 (severe) or higher vital signs AE. This outcome is used to assess the tolerability of the study treatment.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Grade 3 or Higher Vital Signs AEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who experienced at least one Grade 3 (severe) or higher ECG AE. This outcome is used to assess the tolerability of the study treatment.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Grade 3 or Higher ECG AEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 28Population: The safety population includes all participants who received at least one dose of any study treatment.
The number of participants who received all doses of study product. This outcome is used to assess the tolerability of the study treatment.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 Participants
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Frequency of Participants Who Received All Oral Medication Doses
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Maximum Concentration (Cmax) of SLV213 in Plasma After Dose 1
|
617.1 ng/mL
Geometric Coefficient of Variation 65
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Minimum Concentration (Cmin) of SLV213 in Plasma After Dose 1
|
22.45 ng/mL
Geometric Coefficient of Variation 43
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Time of Maximum Concentration (Tmax) of SLV213 in Plasma After Dose 1
|
2.00 h
Interval 1.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Time of Minimum Concentration (Tmin) of SLV213 in Plasma After Dose 1
|
11.80 h
Interval 8.0 to 11.9
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to Infinity (AUC0-inf) of SLV213 in Plasma After Dose 1
|
2234.6 ng*h/mL
Geometric Coefficient of Variation 65
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to 12 h (AUC0-12) of SLV213 in Plasma After Dose 1
|
2172.4 ng*h/mL
Geometric Coefficient of Variation 64
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to the Last Concentration Above the Lower Limit of Quantitation (AUC0-last) of SLV213 in Plasma After Dose 1
|
2157.5 ng*h/mL
Geometric Coefficient of Variation 66
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to the End of the Dosing Interval (AUC0-tau) of SLV213 in Plasma After Dose 1
|
2172.4 ng*h/mL
Geometric Coefficient of Variation 64
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis. t1/2 was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Terminal Half-Life (t1/2) of SLV213 in Plasma After Dose 1
|
2.15 h
Geometric Coefficient of Variation 22
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis. CLT was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Total Clearance (CLT) of SLV213 in Plasma After Dose 1
|
179.0 L/h
Geometric Coefficient of Variation 65
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis. Ke was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Terminal Phase Elimination Rate Constant (Ke) of SLV213 in Plasma After Dose 1
|
0.3220 1/h
Geometric Coefficient of Variation 22
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis. Vd was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Volume of Distribution (Vd) of SLV213 in Plasma After Dose 1
|
555.5 L
Geometric Coefficient of Variation 63
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Dose-normalized AUC0-Tau (AUC0-tau/Dose) of SLV213 in Plasma After Dose 1
|
5.428 ng*h/mL/mg
Geometric Coefficient of Variation 64
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=11 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Dose-normalized Cmax (Cmax/Dose) of SLV213 in Plasma After Dose 1
|
1.544 ng/mL/mg
Geometric Coefficient of Variation 65
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Cmax at Steady State (Cmax,ss) of SLV213 in Plasma After Dose 14
|
419.0 ng/mL
Geometric Coefficient of Variation 58
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Cmin at Steady State (Cmin,ss) of SLV213 in Plasma After Dose 14
|
23.66 ng/mL
Geometric Coefficient of Variation 47
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Average Concentration During the Dosing Interval (Cavg) of SLV213 in Plasma After Dose 14
|
135.2 ng/mL
Geometric Coefficient of Variation 58
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Tmax at Steady State (Tmax,ss) of SLV213 in Plasma After Dose 14
|
2.00 h
Interval 1.0 to 2.1
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Tmin at Steady State (Tmin,ss) of SLV213 in Plasma After Dose 14
|
12.05 h
Interval 12.0 to 12.2
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to 48 h at Steady State (AUC0-48,ss) of SLV213 in Plasma After Dose 14
|
1734.6 ng*h/mL
Geometric Coefficient of Variation 56
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
AUC0-tau at Steady State (AUC0-tau,ss) of SLV213 in Plasma After Dose 14
|
1624.4 ng*h/mL
Geometric Coefficient of Variation 58
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. t1/2 was estimated for parameters meeting the following lambda-z acceptance criteria: rsq\_adjusted (adjusted r squared) \>= 0.90 and includes at least 3 time points after Tmax.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
t1/2 of SLV213 in Plasma After Dose 14
|
3.05 h
Geometric Coefficient of Variation 20
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
CLT at Steady State (CLT,ss) of SLV213 in Plasma After Dose 14
|
246.1 L/h
Geometric Coefficient of Variation 58
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Vd at Steady State (Vd,ss) of SLV213 in Plasma After Dose 14
|
1079.1 L
Geometric Coefficient of Variation 73
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Dose-Normalized AUC0-tau,ss (AUC0-tau,ss/Dose) of SLV213 in Plasma After Dose 14
|
4.061 ng*h/mL/mg
Geometric Coefficient of Variation 58
|
—
|
SECONDARY outcome
Timeframe: 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Dose-Normalized Cmax,ss (Cmax,ss/Dose) of SLV213 in Plasma After Dose 14
|
1.047 ng/mL/mg
Geometric Coefficient of Variation 58
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1, 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
Linearity index is estimated as AUC0-tau,ss (Dose 14)/AUC0-inf (Dose 1). PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 and dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Linearity Index of SLV213 in Plasma
|
0.625 ratio
Geometric Coefficient of Variation 40
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1, 0 h through 48 h post dose 14Population: The PK population includes all randomized participants, including replacement participants, who received at least one dose of study treatment and have at least one quantifiable post-dosing plasma concentration to use for the PK analysis.
RAUC is estimated as AUC0-tau,ss (Dose 14)/AUC0-tau (Dose 1). PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 and dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Accumulation Ratio for AUC (RAUC) of SLV213 in Plasma
|
0.641 ratio
Geometric Coefficient of Variation 40
|
—
|
SECONDARY outcome
Timeframe: 0 h through 12 h post dose 1, 0 h through 48 h post dose 14Population: 0 h through 12 h post dose 1, 0 h through 48 h post dose 14
RCmax is estimated as Cmax,ss (Dose 14)/Cmax (Dose 1). PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 and dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis.
Outcome measures
| Measure |
Cohort 1 - 400 mg SLV213
n=8 Participants
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Accumulation Ratio for Cmax (RCmax) of SLV213 in Plasma
|
0.598 ratio
Geometric Coefficient of Variation 47
|
—
|
Adverse Events
Cohort 1 - 400 mg SLV213
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 - 400 mg SLV213
n=11 participants at risk
400 mg (4 x 100 mg capsules) of SLV213 administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.
|
Placebo
n=5 participants at risk
Placebo participants from Cohort 1. Placebo capsules were administered by the same route as active drug.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Gastrointestinal disorders
Eructation
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 2 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Immune system disorders
Drug hypersensitivity
|
18.2%
2/11 • Number of events 2 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Blood pressure diastolic increased
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/11 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 3 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/11 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Heart rate decreased
|
27.3%
3/11 • Number of events 8 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
40.0%
2/5 • Number of events 5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Orthostatic heart rate response increased
|
63.6%
7/11 • Number of events 23 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
40.0%
2/5 • Number of events 9 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Respiratory rate increased
|
100.0%
11/11 • Number of events 47 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
80.0%
4/5 • Number of events 12 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Nervous system disorders
Dizziness
|
90.9%
10/11 • Number of events 14 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
80.0%
4/5 • Number of events 7 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Nervous system disorders
Taste disorder
|
18.2%
2/11 • Number of events 2 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 3 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Amylase increased
|
9.1%
1/11 • Number of events 4 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Number of events 2 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/11 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Blood calcium decreased
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Blood glucose increased
|
27.3%
3/11 • Number of events 3 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Blood phosphate decrease decreased
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Blood potassium increased
|
0.00%
0/11 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Blood sodium increased
|
9.1%
1/11 • Number of events 2 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Glucose urine present
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Haemoglobin decreased
|
90.9%
10/11 • Number of events 28 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
100.0%
5/5 • Number of events 17 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Lymphocyte count decreased
|
18.2%
2/11 • Number of events 2 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Neutrophil count decreased
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Protein total decreased
|
9.1%
1/11 • Number of events 2 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Protein urine present
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Prothrombin time prolonged
|
18.2%
2/11 • Number of events 2 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
Red blood cells urine positive
|
9.1%
1/11 • Number of events 2 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
0.00%
0/5 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
White blood cell count decreased
|
9.1%
1/11 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
|
Investigations
White blood cells urine positive
|
18.2%
2/11 • Number of events 3 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
20.0%
1/5 • Number of events 1 • All TEAEs were documented from time of starting drug administration through the time of the last assessment (e.g., Day 8 for clinical safety labs and ECGs) or Final Visit (Day 28 +/- 2 days).
Any systemic medical condition, vital sign and ECG measurement, and clinical safety lab test value that was present on Day 1 prior to dosing was considered a baseline findings. If the condition increases in severity or frequency after study product administration, it was reported as a TEAE.
|
Additional Information
George A. Saviolakis, MD, PhD
DynPort Vaccine Company, a GDIT Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60