Trial Outcomes & Findings for Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD) (NCT NCT05454410)
NCT ID: NCT05454410
Last Updated: 2025-04-13
Results Overview
The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline and 24 hours after SC injection
Results posted on
2025-04-13
Participant Flow
All inclusion and exclusion criteria were checked during screening and on Day 1, prior to randomization.
Participant milestones
| Measure |
MIJ821 10 mg
Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
14
|
17
|
|
Overall Study
COMPLETED
|
15
|
14
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
MIJ821 10 mg
Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)
Baseline characteristics by cohort
| Measure |
MIJ821 10 mg
n=15 Participants
Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous injection on Day 1.
|
MIJ821 4 mg
n=14 Participants
Participants received a single dose of 4 mg MIJ821 administered as a subcutaneous injection on Day 1.
|
MIJ821 1 mg
n=14 Participants
Participants received a single dose of 1 mg MIJ821 administered as a subcutaneous injection on Day 1.
|
Placebo
n=17 Participants
Participants received a single dose of 0.9% sodium chloride solution administered as a subcutaneous injection on Day 1.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 12.36 • n=99 Participants
|
43.9 years
STANDARD_DEVIATION 11.29 • n=107 Participants
|
46.9 years
STANDARD_DEVIATION 9.73 • n=206 Participants
|
47.1 years
STANDARD_DEVIATION 12.05 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 11.26 • n=31 Participants
|
|
Sex/Gender, Customized
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Female
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
37 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
52 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
57 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian / Japanese
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 hours after SC injectionPopulation: The Full Analysis Set (FAS) included all randomized participants who received a dose of the randomized treatment. Participants were analyzed according to the assigned treatment groups.
The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel.
Outcome measures
| Measure |
MIJ821 10 mg
n=15 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
n=14 Participants
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
n=14 Participants
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
n=17 Participants
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score 24 Hours (Day 2) After Injection
|
-14.1 Scores on a Scale
Standard Error 1.95
|
-11.4 Scores on a Scale
Standard Error 2.04
|
-8.4 Scores on a Scale
Standard Error 2.02
|
-8.9 Scores on a Scale
Standard Error 1.82
|
SECONDARY outcome
Timeframe: From Day 1 after SC injection to end of study, up to 29 DaysPopulation: The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
A TEAE was defined as an adverse event starting or worsening after the administration of study medication and up to the end of study visit. The following events were considered AESIs: * Dissociation * Sedation * Cardiovascular effects (Blood Pressure changes and QT interval prolongation on electrocardiogram \[ECG\]) * Respiratory effects (difficulty in breathing, changes in oxygen saturation) * Suicidality (suicidal ideation or behavior) * Memory gaps/amnesia * Cystitis or lower urinary tract adverse events
Outcome measures
| Measure |
MIJ821 10 mg
n=15 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
n=14 Participants
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
n=14 Participants
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
n=17 Participants
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)
With at least one AE
|
10 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)
With at least one AESI
|
9 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)
Blood pressure increased
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)
Dissociation
|
5 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)
Derealization
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)
Vision blurred
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)
Amnesia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)
Somnolence
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Including Adverse Events of Special Interest (AESIs)
Sedation
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injectionPopulation: The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data.
Blood samples were collected at the indicated time points for PK analysis. AUClast was defined as the area under the curve from time zero to the last measurable concentration sampling time (tlast).
Outcome measures
| Measure |
MIJ821 10 mg
n=15 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
n=13 Participants
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
n=13 Participants
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of MIJ821 in Plasma for Area Under the Curve From the Time of Dosing to the Time of the Last Measurable Concentration (AUClast)
|
231 h*ng/mL
Geometric Coefficient of Variation 33.5
|
89.5 h*ng/mL
Geometric Coefficient of Variation 45.7
|
5.92 h*ng/mL
Geometric Coefficient of Variation 85.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injectionPopulation: The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data.
Blood samples were collected at the indicated time points for PK analysis. Cmax was defined as the maximum (peak) observed plasma drug concentration after single dose administration.
Outcome measures
| Measure |
MIJ821 10 mg
n=15 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
n=13 Participants
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
n=13 Participants
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
PK of MIJ821 in Plasma for Maximum Serum Concentration (Cmax)
|
42.7 ng/mL
Geometric Coefficient of Variation 37.2
|
17.5 ng/mL
Geometric Coefficient of Variation 46.7
|
2.32 ng/mL
Geometric Coefficient of Variation 55.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.17 hour, 0.33 hour, 0.5 hour, 0.75 hour, 1, 1.5, 2, 4 and 24 hours post injectionPopulation: The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data.
Blood samples were collected at the indicated time points for PK analysis. Tmax was defined as the time to reach maximum (peak) plasma drug concentration after single dose administration (time).
Outcome measures
| Measure |
MIJ821 10 mg
n=15 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
n=14 Participants
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
n=14 Participants
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
PK of MIJ821 in Plasma for Time to Maximum Drug Concentration (Tmax)
|
0.750 hour (h)
Interval 0.333 to 2.0
|
0.500 hour (h)
Interval 0.15 to 1.0
|
0.500 hour (h)
Interval 0.167 to 0.783
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 8, 15, 22 and 29Population: The Full Analysis Set (FAS) included all randomized participants who received a dose of the randomized treatment. Participants were analyzed according to the assigned treatment groups.
The MADRS (SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 - 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS scores were collected electronically by qualified personnel.
Outcome measures
| Measure |
MIJ821 10 mg
n=15 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
n=14 Participants
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
n=14 Participants
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
n=17 Participants
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Change From Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits
Change from Baseline (Day 8)
|
-15.3 Scores on a Scale
Standard Error 2.0
|
-9.9 Scores on a Scale
Standard Error 2.1
|
-8.2 Scores on a Scale
Standard Error 2.0
|
-7.4 Scores on a Scale
Standard Error 1.8
|
|
Change From Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits
Change from Baseline (Day 15)
|
-14.0 Scores on a Scale
Standard Error 2.2
|
-8.5 Scores on a Scale
Standard Error 2.2
|
-11.0 Scores on a Scale
Standard Error 2.2
|
-7.7 Scores on a Scale
Standard Error 2.0
|
|
Change From Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits
Change from Baseline (Day 22)
|
-14.9 Scores on a Scale
Standard Error 2.2
|
-10.7 Scores on a Scale
Standard Error 2.3
|
-9.7 Scores on a Scale
Standard Error 2.3
|
-7.0 Scores on a Scale
Standard Error 2.0
|
|
Change From Baseline in the MADRS Total Scores at Day 8, 15, 22 and 29 Visits
Change from Baseline (Day 29)
|
-14.9 Scores on a Scale
Standard Error 2.3
|
-12.7 Scores on a Scale
Standard Error 2.4
|
-10.7 Scores on a Scale
Standard Error 2.4
|
-7.0 Scores on a Scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline up to 24 HoursPopulation: The Full Analysis Set (FAS) included all randomized participants who received a dose of the randomized treatment. Participants were analyzed according to the assigned treatment groups.
The multiple comparison procedure - modelling (MCP-Mod) approach was an integrated approach used to investigate DR relationships, while confirming efficacy of the test product based on hypothesis testing. A set of candidate models was tested using Multiple Comparison Procedures (MCP) that preserve the family-wise error rate (FWER) to determine the model best representing the underlying DR. Efficacy via DR was established when at least one of the model tests was significant.
Outcome measures
| Measure |
MIJ821 10 mg
n=15 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
n=14 Participants
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
n=14 Participants
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
n=17 Participants
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Dose-response (DR) Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score at 24 Hours After Single SC Injection
|
-14.1 Scores on a Scale
Standard Error 1.95
|
-11.4 Scores on a Scale
Standard Error 2.04
|
-8.4 Scores on a Scale
Standard Error 2.02
|
-8.9 Scores on a Scale
Standard Error 1.82
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 15, 22 and 29Population: The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data.
The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter.
Outcome measures
| Measure |
MIJ821 10 mg
n=41 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameters: Placebo Effect E0, Emax
Exposure-response Relationship Cmax: placebo effect E0
|
NA Scores on a scale
estimates in the Sigmoid emax (or Emax) model were not available due to non-convergence issues
|
—
|
—
|
—
|
|
Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameters: Placebo Effect E0, Emax
Exposure-response Relationship Cmax: Emax
|
NA Scores on a scale
estimates in the Sigmoid emax (or Emax) model were not available due to non-convergence issues
|
—
|
—
|
—
|
|
Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameters: Placebo Effect E0, Emax
Exposure-response Relationship AUClast: placebo effect E0
|
NA Scores on a scale
estimates in the Sigmoid emax (or Emax) model were not available due to non-convergence issues
|
—
|
—
|
—
|
|
Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameters: Placebo Effect E0, Emax
Exposure-response Relationship AUClast: Emax
|
NA Scores on a scale
estimates in the Sigmoid emax (or Emax) model were not available due to non-convergence issues
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 15, 22 and 29Population: The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data.
The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter.
Outcome measures
| Measure |
MIJ821 10 mg
n=41 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: EC50 (Cmax)
|
NA ng/mL
estimates in the Sigmoid emax (or Emax) model were not available due to non-convergence issues
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 15, 22 and 29Population: The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data.
The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter.
Outcome measures
| Measure |
MIJ821 10 mg
n=41 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: EC50 (AUClast)
|
NA h*ng/mL
estimates in the Sigmoid emax (or Emax) model were not available due to non-convergence issues
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 15, 22 and 29Population: The PK analysis set included all participants with at least one available, valid PK concentration measurement, who received any study drug and with no protocol deviations that had an impact on PK data.
The exposure-response relationship was investigated considering PK exposure parameters (AUClast and Cmax) and the change from baseline MADRS score derived at 4 h and 24 h after injection and Day 8, Day 15, Day 22 and Day 29 during the follow-up. The emax model or sigmoid emax model were planned to be fitted for the change from baseline at each follow up visit and the PK exposure parameters, Cmax and AUClast. If the model converges, parameters estimated from the Sigmoid emax model are: the placebo effect E0, EC50, Emax and the hill parameter.
Outcome measures
| Measure |
MIJ821 10 mg
n=41 Participants
Participants received a single dose of 10mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4 mg
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1 mg
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
Participants received a single dose of 0.9% sodium chloride solution administered as a SC injection on Day 1.
|
|---|---|---|---|---|
|
Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: Hill Parameter
Exposure-response Relationship Cmax: Hill parameter
|
NA Hill coefficient
estimates in the Sigmoid emax (or Emax) model were not available due to non-convergence issues
|
—
|
—
|
—
|
|
Exposure-response Relationship of MIJ821 With Respect to Change From Baseline in MADRS Total Score. Estimated Parameter: Hill Parameter
Exposure-response Relationship AUClast: Hill parameter
|
NA Hill coefficient
estimates in the Sigmoid emax (or Emax) model were not available due to non-convergence issues
|
—
|
—
|
—
|
Adverse Events
MIJ821 10 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
MIJ821 4mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MIJ821 1mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
All MIJ821
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
All Participants
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MIJ821 10 mg
n=15 participants at risk
Participants received a single dose of 10 mg MIJ821 administered as a subcutaneous (SC) injection on Day 1.
|
MIJ821 4mg
n=14 participants at risk
Participants received a single dose of 4 mg MIJ821 administered as a SC injection on Day 1.
|
MIJ821 1mg
n=14 participants at risk
Participants received a single dose of 1 mg MIJ821 administered as a SC injection on Day 1.
|
Placebo
n=17 participants at risk
Participants received a single dose of 0.9% sodium chloride solution administered as a subcutaneous injection on Day 1.
|
All MIJ821
n=43 participants at risk
All MIJ821 Dosages
|
All Participants
n=60 participants at risk
All Participants included in the Safety Analysis Set
|
|---|---|---|---|---|---|---|
|
Investigations
Heart rate increased
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Nervous system disorders
Amnesia
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
3.3%
2/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
17.6%
3/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
11.7%
7/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Nervous system disorders
Sedation
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
3.3%
2/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Nervous system disorders
Somnolence
|
26.7%
4/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
11.6%
5/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
10.0%
6/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Eye disorders
Vision blurred
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
11.8%
2/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
3.3%
2/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
General disorders
Injection site erythema
|
20.0%
3/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
5.0%
3/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Infections and infestations
Gastrointestinal infection
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Infections and infestations
Pharyngitis
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Infections and infestations
Tooth infection
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Investigations
Blood pressure increased
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
3.3%
2/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Nervous system disorders
Tension headache
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
7.1%
1/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Psychiatric disorders
Derealisation
|
6.7%
1/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Psychiatric disorders
Dissociation
|
33.3%
5/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
14.3%
2/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
11.8%
2/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
16.3%
7/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
15.0%
9/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/14 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
1.7%
1/60 • Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of 29 days.
The Safety Analysis Set included all participants who received any study drug. Participants were analyzed according to the study treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER