Trial Outcomes & Findings for MW151-101: First-in-human Study of MW151 (NCT NCT04120233)
NCT ID: NCT04120233
Last Updated: 2022-12-30
Results Overview
Percentage of participants experiencing drug-related serious adverse events from the start of study drug administration up to 7-day follow-up.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Seven days
Results posted on
2022-12-30
Participant Flow
The study was initiated on October 11, 2019 and last follow-up was completed on September 16,2021.
A total of 97 subjects were screened and 40 subjects were randomized.
Participant milestones
| Measure |
Placebo
Participants will receive placebo.
Placebo: Matched placebo administered orally
|
Dose 1
Participants will receive 10 mg of MW151.
MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally
|
Dose 2
Participants will receive 20mg of MW151.
MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally
|
Dose 3
Participants will receive 40mg of MW151.
MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally
|
Dose 4
Participants will receive 80mg of MW151.
MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally
|
Dose 5
Participants will receive 160mg of MW151.
MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
6
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants will receive placebo.
Placebo: Matched placebo administered orally
|
Dose 1
Participants will receive 10 mg of MW151.
MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally
|
Dose 2
Participants will receive 20mg of MW151.
MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally
|
Dose 3
Participants will receive 40mg of MW151.
MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally
|
Dose 4
Participants will receive 80mg of MW151.
MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally
|
Dose 5
Participants will receive 160mg of MW151.
MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
MW151-101: First-in-human Study of MW151
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Participants will receive placebo.
Placebo: Matched placebo administered orally
|
Dose 1
n=6 Participants
Participants will receive 10 mg of MW151.
MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally
|
Dose 2
n=6 Participants
Participants will receive 20mg of MW151.
MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally
|
Dose 3
n=6 Participants
Participants will receive 40mg of MW151.
MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally
|
Dose 4
n=6 Participants
Participants will receive 80mg of MW151.
MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally
|
Dose 5
n=6 Participants
Participants will receive 160mg of MW151.
MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
37.9 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
39.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
40.9 years
STANDARD_DEVIATION 6.4 • n=21 Participants
|
35.2 years
STANDARD_DEVIATION 7.4 • n=8 Participants
|
36.8 years
STANDARD_DEVIATION 8.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
40 participants
n=8 Participants
|
|
Height
|
163.3 cm
STANDARD_DEVIATION 5.8 • n=5 Participants
|
178.1 cm
STANDARD_DEVIATION 8.2 • n=7 Participants
|
158.0 cm
STANDARD_DEVIATION 7.5 • n=5 Participants
|
162.5 cm
STANDARD_DEVIATION 1.9 • n=4 Participants
|
169.3 cm
STANDARD_DEVIATION 7.5 • n=21 Participants
|
165.1 cm
STANDARD_DEVIATION 4.3 • n=8 Participants
|
165.9 cm
STANDARD_DEVIATION 8.5 • n=8 Participants
|
|
Weight
|
74.8 kg
STANDARD_DEVIATION 11.7 • n=5 Participants
|
85.3 kg
STANDARD_DEVIATION 15.2 • n=7 Participants
|
70.5 kg
STANDARD_DEVIATION 12.9 • n=5 Participants
|
68.1 kg
STANDARD_DEVIATION 7.6 • n=4 Participants
|
79.6 kg
STANDARD_DEVIATION 17.4 • n=21 Participants
|
75.1 kg
STANDARD_DEVIATION 10.2 • n=8 Participants
|
75.5 kg
STANDARD_DEVIATION 13.1 • n=8 Participants
|
|
Body Mass Index (BMI)
|
28.0 kg/m^2
STANDARD_DEVIATION 3.6 • n=5 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 3.8 • n=7 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 2.6 • n=4 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 4.3 • n=21 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 4.0 • n=8 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 3.7 • n=8 Participants
|
PRIMARY outcome
Timeframe: Seven daysPercentage of participants experiencing drug-related serious adverse events from the start of study drug administration up to 7-day follow-up.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants will receive placebo.
Placebo: Matched placebo administered orally
|
Dose 1
n=6 Participants
Participants will receive 10 mg of MW151.
MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally
|
Dose 2
n=6 Participants
Participants will receive 20mg of MW151.
MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally
|
Dose 3
n=6 Participants
Participants will receive 40mg of MW151.
MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally
|
Dose 4
n=6 Participants
Participants will receive 80mg of MW151.
MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally
|
Dose 5
n=6 Participants
Participants will receive 160mg of MW151.
MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Drug-related Serious Adverse Events.
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dosePopulation: The PK population included all subjects who were administered MW151 and had at least 1 quantifiable concentration of MW151 measurement. One subject in Cohort 4 withdrew prior to the 36h plasma sampling, so that sampling point was excluded from the PK dataset at that timepoint. PK parameters for MW151 cannot be analyzed in the placebo group, as they did not receive the study drug.
Peak serum concentration of MW151.
Outcome measures
| Measure |
Placebo
Participants will receive placebo.
Placebo: Matched placebo administered orally
|
Dose 1
n=6 Participants
Participants will receive 10 mg of MW151.
MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally
|
Dose 2
n=6 Participants
Participants will receive 20mg of MW151.
MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally
|
Dose 3
n=6 Participants
Participants will receive 40mg of MW151.
MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally
|
Dose 4
n=6 Participants
Participants will receive 80mg of MW151.
MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally
|
Dose 5
n=6 Participants
Participants will receive 160mg of MW151.
MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally
|
|---|---|---|---|---|---|---|
|
Maximum Drug Concentration (Cmax)
|
—
|
32.2 ng/mL
Standard Deviation 14.6
|
132.0 ng/mL
Standard Deviation 62.5
|
283.0 ng/mL
Standard Deviation 244
|
361.0 ng/mL
Standard Deviation 53.2
|
1190.0 ng/mL
Standard Deviation 707.0
|
SECONDARY outcome
Timeframe: predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dosePopulation: The PK population included all subjects who were administered MW151 and had at least 1 quantifiable concentration of MW151 measurement. One subject in Cohort 4 withdrew prior to the 36h plasma sampling, so that sampling point was excluded from the PK dataset at that timepoint. PK parameters for MW151 cannot be analyzed in the placebo group, as they did not receive the study drug.
Time required to reach the maximum serum concentration of MW151.
Outcome measures
| Measure |
Placebo
Participants will receive placebo.
Placebo: Matched placebo administered orally
|
Dose 1
n=6 Participants
Participants will receive 10 mg of MW151.
MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally
|
Dose 2
n=6 Participants
Participants will receive 20mg of MW151.
MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally
|
Dose 3
n=6 Participants
Participants will receive 40mg of MW151.
MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally
|
Dose 4
n=6 Participants
Participants will receive 80mg of MW151.
MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally
|
Dose 5
n=6 Participants
Participants will receive 160mg of MW151.
MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally
|
|---|---|---|---|---|---|---|
|
Time to Maximum Drug Concentration (Tmax)
|
—
|
1.8 hours
Standard Deviation 0.4
|
1.6 hours
Standard Deviation 0.7
|
1.5 hours
Standard Deviation 1.4
|
2.3 hours
Standard Deviation 1.4
|
2.0 hours
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dosePopulation: The PK population included all subjects who were administered MW151 and had at least 1 quantifiable concentration of MW151 measurement. One subject in Cohort 4 withdrew prior to the 36h plasma sampling, so that sampling point was excluded from the PK dataset at that timepoint. PK parameters for MW151 cannot be analyzed in the placebo group, as they did not receive the study drug.
Overall drug exposure (h\*ng/mL) determined by calculating the area under the curve (AUC) from a plasma drug concentration-time curve.
Outcome measures
| Measure |
Placebo
Participants will receive placebo.
Placebo: Matched placebo administered orally
|
Dose 1
n=6 Participants
Participants will receive 10 mg of MW151.
MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally
|
Dose 2
n=6 Participants
Participants will receive 20mg of MW151.
MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally
|
Dose 3
n=6 Participants
Participants will receive 40mg of MW151.
MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally
|
Dose 4
n=6 Participants
Participants will receive 80mg of MW151.
MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally
|
Dose 5
n=6 Participants
Participants will receive 160mg of MW151.
MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally
|
|---|---|---|---|---|---|---|
|
Overall Drug Exposure (AUC)
|
—
|
208.0 h*ng/mL
Standard Deviation 91.8
|
741.0 h*ng/mL
Standard Deviation 168.0
|
1250.0 h*ng/mL
Standard Deviation 453.0
|
3120.0 h*ng/mL
Standard Deviation 1290.0
|
7590.0 h*ng/mL
Standard Deviation 1800.0
|
SECONDARY outcome
Timeframe: predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dosePopulation: Placebo: PK parameters for MW151 cannot be analyzed, as they did not receive the study drug. Dose 2: Data from two participants were excluded for being nonacceptable, and were not analyzed. Dose 3, 4 and 5: Data from 5 participants in each group were nonacceptable, and were not analyzed. Non-acceptance data are defined as: R\^2\_adjusted \<0.8 and terminal elimination phase time span \<3 half-lives after Tmax.
Time at which the concentration of MW151 is at half the maximum concentration.
Outcome measures
| Measure |
Placebo
Participants will receive placebo.
Placebo: Matched placebo administered orally
|
Dose 1
n=6 Participants
Participants will receive 10 mg of MW151.
MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally
|
Dose 2
n=4 Participants
Participants will receive 20mg of MW151.
MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally
|
Dose 3
n=1 Participants
Participants will receive 40mg of MW151.
MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally
|
Dose 4
n=1 Participants
Participants will receive 80mg of MW151.
MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally
|
Dose 5
n=1 Participants
Participants will receive 160mg of MW151.
MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally
|
|---|---|---|---|---|---|---|
|
Drug Half-Life (T1/2)
|
—
|
8.2 hour
Standard Deviation 1.9
|
10.6 hour
Standard Deviation 1.4
|
8.8 hour
Standard Deviation NA
Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.
|
10.4 hour
Standard Deviation NA
Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.
|
10.6 hour
Standard Deviation NA
Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.
|
SECONDARY outcome
Timeframe: predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dosePopulation: Placebo: PK parameters for MW151 cannot be analyzed, as they did not receive the study drug. Dose 2: Data from two participants were excluded for being nonacceptable, and were not analyzed. Dose 3, 4 and 5: Data from 5 participants in each group were nonacceptable, and were not analyzed. Non-acceptance data are defined as: R\^2\_adjusted \<0.8 and terminal elimination phase time span \<3 half-lives after Tmax.
Fraction of MW151 eliminated per unit of time (mathematical determination).
Outcome measures
| Measure |
Placebo
Participants will receive placebo.
Placebo: Matched placebo administered orally
|
Dose 1
n=6 Participants
Participants will receive 10 mg of MW151.
MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally
|
Dose 2
n=4 Participants
Participants will receive 20mg of MW151.
MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally
|
Dose 3
n=1 Participants
Participants will receive 40mg of MW151.
MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally
|
Dose 4
n=1 Participants
Participants will receive 80mg of MW151.
MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally
|
Dose 5
n=1 Participants
Participants will receive 160mg of MW151.
MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally
|
|---|---|---|---|---|---|---|
|
Elimination Rate Constant (Kel)
|
—
|
0.09 1/h
Standard Deviation 0.02
|
0.07 1/h
Standard Deviation 0.01
|
0.08 1/h
Standard Deviation NA
Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.
|
0.07 1/h
Standard Deviation NA
Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.
|
0.07 1/h
Standard Deviation NA
Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Participants will receive placebo.
Placebo: Matched placebo administered orally
|
Dose 1
n=6 participants at risk
Participants will receive 10 mg of MW151.
MW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally
|
Dose 2
n=6 participants at risk
Participants will receive 20mg of MW151.
MW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally
|
Dose 3
n=6 participants at risk
Participants will receive 40mg of MW151.
MW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally
|
Dose 4
n=6 participants at risk
Participants will receive 80mg of MW151.
MW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally
|
Dose 5
n=6 participants at risk
Participants will receive 160mg of MW151.
MW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
|
Infections and infestations
Asymptomatic bacteriuria
|
10.0%
1/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
50.0%
3/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
33.3%
2/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
General disorders
Infusion site pain
|
10.0%
1/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Investigations
Heart rate increased
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Investigations
Amylase increased
|
10.0%
1/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Investigations
Blood triglycerides increased
|
10.0%
1/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
33.3%
2/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
33.3%
2/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
|
Vascular disorders
Phlebitis
|
0.00%
0/10 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
16.7%
1/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
0.00%
0/6 • From the start of study drug administration up to 7-day follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place