Trial Outcomes & Findings for Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease (NCT NCT05074498)
NCT ID: NCT05074498
Last Updated: 2023-11-18
Results Overview
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Up to Day 104
Results posted on
2023-11-18
Participant Flow
This was a multi-center study conducted at various centers across United States (US).
This was a 2-part randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) escalation study that evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of TB006 in participants with Alzheimer's disease (AD).
Participant milestones
| Measure |
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 2: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
Part 2: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
|---|---|---|---|---|---|---|
|
Part 1 (Upto Day 104)
STARTED
|
7
|
6
|
6
|
6
|
0
|
0
|
|
Part 1 (Upto Day 104)
COMPLETED
|
6
|
6
|
6
|
5
|
0
|
0
|
|
Part 1 (Upto Day 104)
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Part 2 (Upto Day 104)
STARTED
|
0
|
0
|
0
|
0
|
63
|
66
|
|
Part 2 (Upto Day 104)
COMPLETED
|
0
|
0
|
0
|
0
|
58
|
64
|
|
Part 2 (Upto Day 104)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
5
|
2
|
Reasons for withdrawal
| Measure |
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 2: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
Part 2: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
|---|---|---|---|---|---|---|
|
Part 1 (Upto Day 104)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1 (Upto Day 104)
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Upto Day 104)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Part 2 (Upto Day 104)
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 2 (Upto Day 104)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Part 2 (Upto Day 104)
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
Part 1: Placebo
n=6 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 2: TB006 1000 mg qw
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
Part 2: Placebo
n=66 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
72.3 Years
STANDARD_DEVIATION 3.25 • n=5 Participants
|
73.0 Years
STANDARD_DEVIATION 10.41 • n=7 Participants
|
71.5 Years
STANDARD_DEVIATION 6.77 • n=5 Participants
|
72.2 Years
STANDARD_DEVIATION 6.74 • n=4 Participants
|
73.5 Years
STANDARD_DEVIATION 9.30 • n=21 Participants
|
71.5 Years
STANDARD_DEVIATION 7.65 • n=8 Participants
|
72.2 Years
STANDARD_DEVIATION 7.35 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
86 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
68 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
75 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
77 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
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
138 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to Day 104Population: Safety Population.
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
2 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameters including ALT, ALP, AST and CK. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Kinase (CK)
ALT
|
5.4 International Units per Liter
Standard Deviation 14.79
|
-1.7 International Units per Liter
Standard Deviation 2.21
|
-5.5 International Units per Liter
Standard Deviation 5.32
|
-0.7 International Units per Liter
Standard Deviation 10.33
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Kinase (CK)
ALP
|
9.0 International Units per Liter
Standard Deviation 15.98
|
-0.6 International Units per Liter
Standard Deviation 9.11
|
-4.0 International Units per Liter
Standard Deviation 5.59
|
-2.2 International Units per Liter
Standard Deviation 10.05
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Kinase (CK)
AST
|
3.2 International Units per Liter
Standard Deviation 13.65
|
-0.1 International Units per Liter
Standard Deviation 2.27
|
-3.8 International Units per Liter
Standard Deviation 5.23
|
-1.3 International Units per Liter
Standard Deviation 7.61
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Kinase (CK)
CK
|
-10.4 International Units per Liter
Standard Deviation 14.03
|
22.0 International Units per Liter
Standard Deviation 39.27
|
0.5 International Units per Liter
Standard Deviation 44.37
|
0.3 International Units per Liter
Standard Deviation 65.56
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameters including albumin and protein. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin
|
-0.04 grams per deciliter
Standard Deviation 0.167
|
-0.14 grams per deciliter
Standard Deviation 0.199
|
0.02 grams per deciliter
Standard Deviation 0.098
|
-0.03 grams per deciliter
Standard Deviation 0.367
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein
|
-0.08 grams per deciliter
Standard Deviation 0.363
|
-0.20 grams per deciliter
Standard Deviation 0.316
|
0.12 grams per deciliter
Standard Deviation 0.183
|
-0.05 grams per deciliter
Standard Deviation 0.589
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameters including Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Calcium
|
-0.18 milligrams per deciliter
Standard Deviation 0.356
|
-0.13 milligrams per deciliter
Standard Deviation 0.373
|
0.17 milligrams per deciliter
Standard Deviation 0.280
|
-0.02 milligrams per deciliter
Standard Deviation 0.360
|
|
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Cholesterol
|
-13.4 milligrams per deciliter
Standard Deviation 47.79
|
-15.4 milligrams per deciliter
Standard Deviation 21.62
|
-2.7 milligrams per deciliter
Standard Deviation 10.35
|
6.2 milligrams per deciliter
Standard Deviation 74.37
|
|
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Creatinine
|
-0.040 milligrams per deciliter
Standard Deviation 0.142
|
0.047 milligrams per deciliter
Standard Deviation 0.081
|
0.153 milligrams per deciliter
Standard Deviation 0.377
|
0.108 milligrams per deciliter
Standard Deviation 0.143
|
|
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Direct Bilirubin
|
-0.022 milligrams per deciliter
Standard Deviation 0.030
|
-0.007 milligrams per deciliter
Standard Deviation 0.032
|
-0.003 milligrams per deciliter
Standard Deviation 0.033
|
0.000 milligrams per deciliter
Standard Deviation 0.020
|
|
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Glucose
|
8.2 milligrams per deciliter
Standard Deviation 49.94
|
34.3 milligrams per deciliter
Standard Deviation 55.23
|
-15.0 milligrams per deciliter
Standard Deviation 18.51
|
21.3 milligrams per deciliter
Standard Deviation 45.45
|
|
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
HDL Cholesterol
|
4.0 milligrams per deciliter
Standard Deviation 17.13
|
-3.6 milligrams per deciliter
Standard Deviation 5.19
|
-3.0 milligrams per deciliter
Standard Deviation 4.65
|
0.2 milligrams per deciliter
Standard Deviation 13.98
|
|
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
LDL Cholesterol
|
-14.8 milligrams per deciliter
Standard Deviation 46.23
|
-9.0 milligrams per deciliter
Standard Deviation 9.04
|
-1.8 milligrams per deciliter
Standard Deviation 9.33
|
-3.5 milligrams per deciliter
Standard Deviation 64.62
|
|
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Total Bilirubin
|
-0.134 milligrams per deciliter
Standard Deviation 0.225
|
-0.036 milligrams per deciliter
Standard Deviation 0.093
|
-0.005 milligrams per deciliter
Standard Deviation 0.227
|
0.032 milligrams per deciliter
Standard Deviation 0.132
|
|
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Triglycerides
|
-23.8 milligrams per deciliter
Standard Deviation 39.06
|
-23.3 milligrams per deciliter
Standard Deviation 69.65
|
12.2 milligrams per deciliter
Standard Deviation 17.72
|
18.7 milligrams per deciliter
Standard Deviation 104.95
|
|
Part 1: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL (High Density Lipoprotein) Cholesterol, LDL (Low Density Lipoprotein) Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Urea Nitrogen
|
1.30 milligrams per deciliter
Standard Deviation 4.266
|
-0.40 milligrams per deciliter
Standard Deviation 2.171
|
6.95 milligrams per deciliter
Standard Deviation 8.277
|
2.43 milligrams per deciliter
Standard Deviation 3.449
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameters including Hemoglobin A1C. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Hemoglobin A1C
|
-0.14 percentage of glycosylated hemoglobin
Standard Deviation 1.011
|
0.06 percentage of glycosylated hemoglobin
Standard Deviation 0.162
|
-0.02 percentage of glycosylated hemoglobin
Standard Deviation 0.567
|
-0.33 percentage of glycosylated hemoglobin
Standard Deviation 0.625
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameters including Potassium and Sodium. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Potassium and Sodium
Potassium
|
0.02 Millimoles per liter
Standard Deviation 0.259
|
0.10 Millimoles per liter
Standard Deviation 0.476
|
-0.15 Millimoles per liter
Standard Deviation 0.288
|
0.07 Millimoles per liter
Standard Deviation 0.378
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters: Potassium and Sodium
Sodium
|
-1.2 Millimoles per liter
Standard Deviation 2.39
|
-1.0 Millimoles per liter
Standard Deviation 2.24
|
0.8 Millimoles per liter
Standard Deviation 1.72
|
-1.2 Millimoles per liter
Standard Deviation 2.56
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameters including Thyrotropin. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Thyrotropin
|
-0.246 micro-international units per milliliter
Standard Deviation 0.372
|
1.209 micro-international units per milliliter
Standard Deviation 3.114
|
-0.343 micro-international units per milliliter
Standard Deviation 0.298
|
-0.370 micro-international units per milliliter
Standard Deviation 1.312
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameters including Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes
|
-0.036 10^3 cells per microliter
Standard Deviation 0.250
|
-0.264 10^3 cells per microliter
Standard Deviation 0.188
|
-0.025 10^3 cells per microliter
Standard Deviation 0.241
|
-0.037 10^3 cells per microliter
Standard Deviation 1.265
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils
|
0.006 10^3 cells per microliter
Standard Deviation 0.013
|
-0.023 10^3 cells per microliter
Standard Deviation 0.015
|
-0.005 10^3 cells per microliter
Standard Deviation 0.019
|
0.005 10^3 cells per microliter
Standard Deviation 0.028
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils
|
0.030 10^3 cells per microliter
Standard Deviation 0.173
|
0.014 10^3 cells per microliter
Standard Deviation 0.138
|
0.003 10^3 cells per microliter
Standard Deviation 0.068
|
0.038 10^3 cells per microliter
Standard Deviation 0.089
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes
|
-0.28 10^3 cells per microliter
Standard Deviation 1.092
|
-0.76 10^3 cells per microliter
Standard Deviation 0.650
|
0.00 10^3 cells per microliter
Standard Deviation 1.292
|
0.40 10^3 cells per microliter
Standard Deviation 1.563
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes
|
0.028 10^3 cells per microliter
Standard Deviation 0.062
|
-0.094 10^3 cells per microliter
Standard Deviation 0.118
|
-0.017 10^3 cells per microliter
Standard Deviation 0.114
|
0.032 10^3 cells per microliter
Standard Deviation 0.108
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils
|
-0.318 10^3 cells per microliter
Standard Deviation 1.145
|
-0.396 10^3 cells per microliter
Standard Deviation 0.719
|
0.078 10^3 cells per microliter
Standard Deviation 1.171
|
0.368 10^3 cells per microliter
Standard Deviation 0.641
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets
|
-4.5 10^3 cells per microliter
Standard Deviation 50.16
|
-9.1 10^3 cells per microliter
Standard Deviation 37.53
|
5.0 10^3 cells per microliter
Standard Deviation 37.25
|
-9.6 10^3 cells per microliter
Standard Deviation 89.83
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameter: Ery. MCH. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocyte. Mean Corpuscular Hemoglobin (Ery. MCH)
|
-0.34 picograms
Standard Deviation 0.631
|
-0.40 picograms
Standard Deviation 1.134
|
-0.05 picograms
Standard Deviation 0.579
|
1.02 picograms
Standard Deviation 3.511
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameter: Hematocrit. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
|
0.32 Percentage
Standard Deviation 2.493
|
0.69 Percentage
Standard Deviation 2.563
|
1.18 Percentage
Standard Deviation 2.105
|
1.18 Percentage
Standard Deviation 7.919
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameter: Erythrocytes and Reticulocytes. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes and Reticulocytes
Erythrocytes
|
0.024 10^6 cells per microliter
Standard Deviation 0.211
|
0.039 10^6 cells per microliter
Standard Deviation 0.401
|
0.012 10^6 cells per microliter
Standard Deviation 0.219
|
-0.108 10^6 cells per microliter
Standard Deviation 0.625
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes and Reticulocytes
Reticulocytes
|
-0.005 10^6 cells per microliter
Standard Deviation 0.009
|
-0.011 10^6 cells per microliter
Standard Deviation 0.017
|
-0.005 10^6 cells per microliter
Standard Deviation 0.004
|
-0.008 10^6 cells per microliter
Standard Deviation 0.008
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameter: Ery. MCV. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocyte. Mean Corpuscular Volume (Ery. MCV)
|
0.20 femtoliters
Standard Deviation 2.699
|
0.80 femtoliters
Standard Deviation 1.926
|
2.45 femtoliters
Standard Deviation 1.343
|
5.42 femtoliters
Standard Deviation 5.724
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameter: Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
|
-0.10 grams per deciliter
Standard Deviation 0.877
|
-0.06 grams per deciliter
Standard Deviation 0.779
|
0.00 grams per deciliter
Standard Deviation 0.465
|
0.08 grams per deciliter
Standard Deviation 3.260
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Urine samples were collected for analysis of Urine pH. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=5 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Urine Potential of Hydrogen (pH)
|
-0.80 potential of Hydrogen
Standard Deviation 0.975
|
-0.36 potential of Hydrogen
Standard Deviation 1.215
|
0.40 potential of Hydrogen
Standard Deviation 1.294
|
-0.50 potential of Hydrogen
Standard Deviation 1.612
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Urine samples were collected for analysis of Urine specific gravity. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=5 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Urine Specific Gravity
|
0.007 Ratio
Standard Deviation 0.010
|
0.003 Ratio
Standard Deviation 0.008
|
0.003 Ratio
Standard Deviation 0.006
|
0.004 Ratio
Standard Deviation 0.011
|
PRIMARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Urine samples were collected for analysis of Urobilinogen. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=5 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Urobilinogen
|
0.00 milligrams per deciliter
Standard Deviation 0.000
|
0.00 milligrams per deciliter
Standard Deviation 0.462
|
-0.16 milligrams per deciliter
Standard Deviation 0.358
|
-0.13 milligrams per deciliter
Standard Deviation 0.602
|
PRIMARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Vital signs including DBP and SBP was measured by at least 5 minutes of rest with the participant in a quiet setting without distractions (eg, television, cell phones). Blood pressure measurements were taken with the participant in the sitting position. Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP
|
-7.2 Millimeters of mercury
Standard Deviation 9.09
|
-2.1 Millimeters of mercury
Standard Deviation 12.06
|
-2.3 Millimeters of mercury
Standard Deviation 10.37
|
-1.0 Millimeters of mercury
Standard Deviation 3.03
|
|
Part 1: Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP
|
2.2 Millimeters of mercury
Standard Deviation 17.74
|
-10.4 Millimeters of mercury
Standard Deviation 13.39
|
3.5 Millimeters of mercury
Standard Deviation 9.61
|
-6.2 Millimeters of mercury
Standard Deviation 13.17
|
PRIMARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Vital signs including respiratory rate was measured by at least 5 minutes of rest with the participant in a quiet setting without distractions (eg, television, cell phones). Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Respiratory Rate
|
-0.2 breaths per minute
Standard Deviation 1.30
|
0.0 breaths per minute
Standard Deviation 0.00
|
-0.7 breaths per minute
Standard Deviation 2.16
|
0.3 breaths per minute
Standard Deviation 1.03
|
PRIMARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Vital signs including temperature was measured by at least 5 minutes of rest with the participant in a quiet setting without distractions (eg, television, cell phones). Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Temperature
|
-0.22 degrees Celsius
Standard Deviation 0.130
|
0.26 degrees Celsius
Standard Deviation 0.351
|
-0.37 degrees Celsius
Standard Deviation 0.350
|
-0.03 degrees Celsius
Standard Deviation 0.833
|
PRIMARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Vital signs including heart rate was measured by at least 5 minutes of rest with the participant in a quiet setting without distractions (eg, television, cell phones). Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Heart Rate
|
-4.2 Beats per minute
Standard Deviation 9.50
|
-2.0 Beats per minute
Standard Deviation 8.00
|
3.3 Beats per minute
Standard Deviation 3.72
|
4.0 Beats per minute
Standard Deviation 5.73
|
PRIMARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
12-lead ECG measurements was obtained using an ECG machine that automatically calculates the heart rate. Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate
|
-3.4 Beats per minute
Standard Deviation 4.87
|
-4.8 Beats per minute
Standard Deviation 5.78
|
-0.9 Beats per minute
Standard Deviation 4.00
|
3.0 Beats per minute
Standard Deviation 3.82
|
PRIMARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
12-lead ECG measurements was obtained using an ECG machine that automatically calculates the PR interval, QRS duration, QT interval and QT Corrected using Bazett's formula (QTcB). Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in ECG Parameters
QTcB Interval
|
-15.2 milliseconds
Standard Deviation 4.15
|
8.1 milliseconds
Standard Deviation 11.37
|
-6.6 milliseconds
Standard Deviation 12.98
|
9.9 milliseconds
Standard Deviation 11.50
|
|
Part 1: Change From Baseline in ECG Parameters
PR Interval
|
14.9 milliseconds
Standard Deviation 5.16
|
4.8 milliseconds
Standard Deviation 10.07
|
0.7 milliseconds
Standard Deviation 5.90
|
-11.0 milliseconds
Standard Deviation 14.74
|
|
Part 1: Change From Baseline in ECG Parameters
QRS Duration
|
-4.1 milliseconds
Standard Deviation 13.50
|
0.3 milliseconds
Standard Deviation 3.07
|
1.1 milliseconds
Standard Deviation 5.27
|
1.0 milliseconds
Standard Deviation 7.16
|
|
Part 1: Change From Baseline in ECG Parameters
QT Interval
|
-5.0 milliseconds
Standard Deviation 11.47
|
21.9 milliseconds
Standard Deviation 12.72
|
-2.9 milliseconds
Standard Deviation 10.48
|
0.3 milliseconds
Standard Deviation 9.36
|
PRIMARY outcome
Timeframe: Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
The C-SSRS is an interview-based instrument to systematically assess suicidal ideation and suicidal behavior. Number of participants that have an affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) were reported. The total score ranges from 0 (no ideation present) to 5 (active suicidal ideation with specific plan and intent); higher scores indicate worse symptoms.
Outcome measures
| Measure |
Part 1: Placebo
n=5 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Any suicidal behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Actual attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Wish to be dead
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Non-specific active suicidal thoughts
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Active suicidal ideation without any methods without intent to act
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Active suicidal ideation with some intent to act, without specific plan
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Active suicidal ideation with specific plan and intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Interrupted attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Aborted attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Most recent attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
First attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Lethal attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 104Population: Full analysis set comprised of all participants who are randomly assigned to study drug. This analysis was planned but data was not captured in the database.
A complete physical examination included, at a minimum, assessment of the Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 104Population: Full Analysis Set. This analysis was planned but data was not captured in the database.
The neurological examination assessed mental status, motor and sensory skills, hearing and speech, vision, coordination, and balance. This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 and Day 29Population: Pharmacokinetic Analysis Set comprises of all participants who received at least 1 dose of TB006 and have at least 1 post-dose blood sample with measurable TB006 concentrations. Only those participants with data available at specified timepoints has been presented.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of TB006. PK parameters were analyzed using standard non-compartmental analysis. AUCtau normalized to the actual administered dose is presented. The AUCtau was divided by the actual dose strength to get the normalized area under the concentration-time curve.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=5 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Dose Normalized Area Under the Concentration Time Curve Over a Dosing Interval (AUCtau) of TB006
Day 1
|
—
|
39.81 hours*micrograms/milliliter/milligram
Geometric Coefficient of Variation 23.17
|
29.87 hours*micrograms/milliliter/milligram
Geometric Coefficient of Variation 38.15
|
11.93 hours*micrograms/milliliter/milligram
Geometric Coefficient of Variation 100.21
|
|
Part 1: Dose Normalized Area Under the Concentration Time Curve Over a Dosing Interval (AUCtau) of TB006
Day 29
|
—
|
125.92 hours*micrograms/milliliter/milligram
Geometric Coefficient of Variation 18.01
|
117.75 hours*micrograms/milliliter/milligram
Geometric Coefficient of Variation 24.52
|
82.95 hours*micrograms/milliliter/milligram
Geometric Coefficient of Variation 18.18
|
PRIMARY outcome
Timeframe: At Days 1, 8 and 29Population: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected at indicated time points for PK analysis of TB006. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Time at Which Maximum Plasma Concentration Occurs (Tmax) of TB006
Day 29
|
—
|
2.03 hours
Interval 1.1 to 5.1
|
2.18 hours
Interval 1.1 to 7.0
|
2.00 hours
Interval 1.0 to 7.0
|
|
Part 1: Time at Which Maximum Plasma Concentration Occurs (Tmax) of TB006
Day 1
|
—
|
1.12 hours
Interval 1.0 to 7.0
|
2.01 hours
Interval 1.1 to 5.0
|
2.00 hours
Interval 1.0 to 5.0
|
|
Part 1: Time at Which Maximum Plasma Concentration Occurs (Tmax) of TB006
Day 8
|
—
|
1.23 hours
Interval 1.0 to 2.0
|
1.60 hours
Interval 1.2 to 5.0
|
2.50 hours
Interval 1.1 to 5.0
|
PRIMARY outcome
Timeframe: At Days 1, 8 and 29Population: Pharmacokinetic Analysis Set. Only those participants with data available at specified timepoints has been presented.
Blood samples were collected at indicated time points for PK analysis of TB006. PK parameters were analyzed using standard non-compartmental analysis. Cmax normalized to the actual administered dose is presented. The Cmax was divided by the actual dose strength to get the normalized maximum observed plasma concentration.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Dose Normalized Maximum Observed Plasma Concentration (Cmax) of TB006
Day 1
|
—
|
0.36 micrograms/milliliter/milligram
Geometric Coefficient of Variation 25.72
|
0.29 micrograms/milliliter/milligram
Geometric Coefficient of Variation 36.97
|
0.07 micrograms/milliliter/milligram
Geometric Coefficient of Variation 105.32
|
|
Part 1: Dose Normalized Maximum Observed Plasma Concentration (Cmax) of TB006
Day 8
|
—
|
0.58 micrograms/milliliter/milligram
Geometric Coefficient of Variation 27.57
|
0.49 micrograms/milliliter/milligram
Geometric Coefficient of Variation 26.77
|
0.30 micrograms/milliliter/milligram
Geometric Coefficient of Variation 30.27
|
|
Part 1: Dose Normalized Maximum Observed Plasma Concentration (Cmax) of TB006
Day 29
|
—
|
0.95 micrograms/milliliter/milligram
Geometric Coefficient of Variation 18.15
|
0.85 micrograms/milliliter/milligram
Geometric Coefficient of Variation 22.89
|
0.61 micrograms/milliliter/milligram
Geometric Coefficient of Variation 13.40
|
PRIMARY outcome
Timeframe: Day 8 and Day 29Population: Pharmacokinetic Analysis Set. Only those participants with data available at specified timepoints has been presented.
Blood samples were collected at indicated time points for PK analysis of TB006. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=5 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Concentration at the End of a Dosing Interval (Ctrough) of TB006
Day 8
|
—
|
25.77 micrograms per milliliter
Geometric Coefficient of Variation 21.23
|
71.44 micrograms per milliliter
Geometric Coefficient of Variation 20.75
|
68.62 micrograms per milliliter
Geometric Coefficient of Variation 70.91
|
|
Part 1: Concentration at the End of a Dosing Interval (Ctrough) of TB006
Day 29
|
—
|
76.69 micrograms per milliliter
Geometric Coefficient of Variation 19.62
|
204.77 micrograms per milliliter
Geometric Coefficient of Variation 20.46
|
348.20 micrograms per milliliter
Geometric Coefficient of Variation 22.34
|
PRIMARY outcome
Timeframe: At Day 29Population: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected at indicated time points for PK analysis of TB006. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=4 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Terminal Elimination Phase Half-life (t1/2) of TB006
|
—
|
711.49 hours
Geometric Coefficient of Variation 19.87
|
757.59 hours
Geometric Coefficient of Variation 22.80
|
739.50 hours
Geometric Coefficient of Variation 14.90
|
PRIMARY outcome
Timeframe: At Day 29Population: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected at indicated time points for PK analysis of TB006. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=5 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Total Clearance (CL) of TB006
|
—
|
7.94 milliliters per hour
Geometric Coefficient of Variation 17.06
|
8.49 milliliters per hour
Geometric Coefficient of Variation 19.27
|
12.06 milliliters per hour
Geometric Coefficient of Variation 19.68
|
PRIMARY outcome
Timeframe: At Day 29Population: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected at indicated time points for PK analysis of TB006. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=4 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Volume of Distribution (Vd) of TB006
|
—
|
8151.47 milliliters
Geometric Coefficient of Variation 21.38
|
9282.51 milliliters
Geometric Coefficient of Variation 28.97
|
13617.70 milliliters
Geometric Coefficient of Variation 30.63
|
PRIMARY outcome
Timeframe: Day 1 (Predose), Day 8 (Predose), Day 36 and Day 104Population: Safety Analysis Set.
Plasma samples were collected at indicated time points for the determination of anti-TB006 antibodies. Plasma samples were screened for antibodies binding to TB006 and the titer of confirmed positive samples has been reported.
Outcome measures
| Measure |
Part 1: Placebo
n=6 Participants
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 Participants
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Anti-TB006 Antibodies (Immunogenicity of TB006)
Day 36
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Anti-TB006 Antibodies (Immunogenicity of TB006)
Day 1 (Predose)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Anti-TB006 Antibodies (Immunogenicity of TB006)
Day 8 (Predose)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Anti-TB006 Antibodies (Immunogenicity of TB006)
Day 104
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 104Population: Efficacy Analysis Set comprised of all participants who received assigned dose of TB006 in Part 2 and the participants enrolled at the same TB006 dose level in Part 1, as well as all placebo participants were included and had at least one post-dose evaluable Pharmacodynamic assessment across participant.
The Clinical Dementia Rating was obtained through semi-structured interviews of participants and informants, and cognitive functioning was rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain was rated on a five-point scale of functioning as follows: 0: no impairment; 0.5: questionable impairment; 1: mild impairment; 2: moderate impairment; and 3: severe impairment. The Clinical Dementia Rating Scale - Sum of Boxes was based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes, and higher total scores represent worse outcomes. Baseline was defined as the last available value prior to the subject receiving the first study drug infusion on Day 1. Change from Baseline value was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=67 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=72 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline Through Day 104 on the Clinical Dementia Rating Scale - Sum of Boxes Total Score
|
—
|
0.01 Scores on a scale
Standard Error 0.147
|
0.35 Scores on a scale
Standard Error 0.142
|
—
|
SECONDARY outcome
Timeframe: Baseline through Day 36Population: Efficacy Analysis Set.
The Clinical Dementia Rating was obtained through semi-structured interviews of participants and informants, and cognitive functioning was rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain was rated on a five-point scale of functioning as follows: 0: no impairment; 0.5: questionable impairment; 1: mild impairment; 2: moderate impairment; and 3: severe impairment. The Clinical Dementia Rating Scale - Sum of Boxes was based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes, and higher total scores represent worse outcomes. Baseline was defined as the last available value prior to the subject receiving the first study drug infusion on Day 1. Change from Baseline value was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=67 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=72 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline Through Day 36 on the Clinical Dementia Rating Scale - Sum of Boxes Total Score
|
—
|
-0.16 Scores on a scale
Standard Error 0.162
|
0.23 Scores on a scale
Standard Error 0.157
|
—
|
SECONDARY outcome
Timeframe: At Days 36 and 104Population: Efficacy Analysis Set.
The Clinical Dementia Rating is obtained through semi-structured interviews of participants and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The Clinical Dementia Rating Scale - Sum of Boxes is based on summing each of the domain box scores with total scores ranging from 0-18, where lower total scores represent better outcomes, and higher total scores represent worse outcomes. A responder was defined as a participant with at least 1 point improvement from Baseline on the Sum of Boxes score. Percentage of responders on the Clinical Dementia Rating Scale - Sum of Boxes has been presented.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=67 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=72 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Percentage of Responders on the Clinical Dementia Rating Scale - Sum of Boxes
Day 36
|
—
|
25.4 Percentage of responders
|
9.7 Percentage of responders
|
—
|
|
Part 2: Percentage of Responders on the Clinical Dementia Rating Scale - Sum of Boxes
Day 104
|
—
|
22.4 Percentage of responders
|
15.3 Percentage of responders
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 36 and 104Population: Efficacy Analysis Set. Only those participants with data available at specified timepoints has been presented.
The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia participants. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from Baseline. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=66 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=70 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline on Mini-Mental State Examination (MMSE) Score
Day 36
|
—
|
1.2 Scores on a scale
Standard Deviation 2.59
|
0.2 Scores on a scale
Standard Deviation 2.52
|
—
|
|
Part 2: Change From Baseline on Mini-Mental State Examination (MMSE) Score
Day 104
|
—
|
1.0 Scores on a scale
Standard Deviation 3.10
|
0.6 Scores on a scale
Standard Deviation 2.97
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Days 36 and 104Population: Efficacy Analysis Set. Only those participants with data available at specified time points has been presented.
The NPI was a questionnaire that quantified psychiatric symptoms and behavioral disorders in dementia. A total of 12 items (the original NPI-10 consisting of 10 behavioral domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor behavior, The NPI total score was calculated by adding the scores of the domains (each domain scores ranges from 0 to 12). The NPI total score ranges from 0 to 120 with higher scores indicating greater behavioral impairment. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=66 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=69 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline on the Neuropsychiatric Inventory (NPI) Score
Day 36
|
—
|
-2.5 Scores on a scale
Standard Deviation 8.10
|
-0.8 Scores on a scale
Standard Deviation 9.12
|
—
|
|
Part 2: Change From Baseline on the Neuropsychiatric Inventory (NPI) Score
Day 104
|
—
|
-3.5 Scores on a scale
Standard Deviation 11.47
|
-1.1 Scores on a scale
Standard Deviation 6.79
|
—
|
SECONDARY outcome
Timeframe: Up to Day 104Population: Safety Population.
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=66 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Number of Participants With AEs and SAEs
Any AE
|
—
|
28 Participants
|
17 Participants
|
—
|
|
Part 2: Number of Participants With AEs and SAEs
Any SAE
|
—
|
4 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameters including ALT, ALP, AST and CK. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=64 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK
ALT
|
—
|
-0.5 International Units per Liter
Standard Deviation 12.88
|
-0.4 International Units per Liter
Standard Deviation 5.40
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK
ALP
|
—
|
1.0 International Units per Liter
Standard Deviation 12.01
|
0.0 International Units per Liter
Standard Deviation 11.92
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK
AST
|
—
|
-0.4 International Units per Liter
Standard Deviation 10.44
|
-0.5 International Units per Liter
Standard Deviation 3.58
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK
CK
|
—
|
-14.3 International Units per Liter
Standard Deviation 77.24
|
6.3 International Units per Liter
Standard Deviation 52.07
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameters including albumin and protein. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=64 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin
|
—
|
-0.10 grams per deciliter
Standard Deviation 0.300
|
-0.01 grams per deciliter
Standard Deviation 0.251
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein
|
—
|
-0.10 grams per deciliter
Standard Deviation 0.470
|
0.00 grams per deciliter
Standard Deviation 0.404
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameters including Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=64 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
LDL Cholesterol
|
—
|
-7.5 milligrams per deciliter
Standard Deviation 24.64
|
-4.6 milligrams per deciliter
Standard Deviation 23.63
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Total Bilirubin
|
—
|
0.023 milligrams per deciliter
Standard Deviation 0.157
|
-0.014 milligrams per deciliter
Standard Deviation 0.128
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Calcium
|
—
|
-0.09 milligrams per deciliter
Standard Deviation 0.437
|
-0.11 milligrams per deciliter
Standard Deviation 0.432
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Cholesterol
|
—
|
-5.8 milligrams per deciliter
Standard Deviation 32.30
|
0.3 milligrams per deciliter
Standard Deviation 28.17
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Creatinine
|
—
|
0.014 milligrams per deciliter
Standard Deviation 0.098
|
-0.017 milligrams per deciliter
Standard Deviation 0.124
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Direct Bilirubin
|
—
|
0.005 milligrams per deciliter
Standard Deviation 0.037
|
-0.006 milligrams per deciliter
Standard Deviation 0.030
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Glucose
|
—
|
-5.6 milligrams per deciliter
Standard Deviation 26.98
|
-6.3 milligrams per deciliter
Standard Deviation 27.92
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
HDL Cholesterol
|
—
|
-2.4 milligrams per deciliter
Standard Deviation 8.49
|
-0.3 milligrams per deciliter
Standard Deviation 8.26
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Triglycerides
|
—
|
-9.2 milligrams per deciliter
Standard Deviation 73.95
|
-0.4 milligrams per deciliter
Standard Deviation 46.29
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameters: Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, HDL Cholesterol, LDL Cholesterol, Total Bilirubin, Triglycerides and Urea Nitrogen
Urea Nitrogen
|
—
|
0.41 milligrams per deciliter
Standard Deviation 3.817
|
-1.03 milligrams per deciliter
Standard Deviation 4.777
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameter including Hemoglobin A1C. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=54 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameter: Hemoglobin A1C
|
—
|
-0.06 percentage of glycosylated hemoglobin
Standard Deviation 0.638
|
0.07 percentage of glycosylated hemoglobin
Standard Deviation 0.555
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameters including Potassium and Sodium. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=64 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Potassium and Sodium
Potassium
|
—
|
-0.14 Millimoles per liter
Standard Deviation 0.469
|
-0.13 Millimoles per liter
Standard Deviation 0.521
|
—
|
|
Part 2: Change From Baseline in Clinical Chemistry Parameters: Potassium and Sodium
Sodium
|
—
|
-0.7 Millimoles per liter
Standard Deviation 2.11
|
-0.7 Millimoles per liter
Standard Deviation 3.05
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following clinical chemistry parameter including Thyrotropin. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=64 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Clinical Chemistry Parameter: Thyrotropin
|
—
|
-0.118 micro-international units per milliliter
Standard Deviation 0.619
|
0.134 micro-international units per milliliter
Standard Deviation 1.000
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameters including Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils
|
—
|
-0.004 10^3 cells per microliter
Standard Deviation 0.027
|
-0.002 10^3 cells per microliter
Standard Deviation 0.022
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils
|
—
|
-0.008 10^3 cells per microliter
Standard Deviation 0.113
|
-0.040 10^3 cells per microliter
Standard Deviation 0.130
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes
|
—
|
-0.26 10^3 cells per microliter
Standard Deviation 1.383
|
-0.02 10^3 cells per microliter
Standard Deviation 1.244
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes
|
—
|
-0.118 10^3 cells per microliter
Standard Deviation 0.392
|
-0.053 10^3 cells per microliter
Standard Deviation 0.411
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes
|
—
|
-0.021 10^3 cells per microliter
Standard Deviation 0.109
|
0.003 10^3 cells per microliter
Standard Deviation 0.107
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils
|
—
|
-0.109 10^3 cells per microliter
Standard Deviation 1.295
|
0.067 10^3 cells per microliter
Standard Deviation 1.206
|
—
|
|
Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets
|
—
|
-1.9 10^3 cells per microliter
Standard Deviation 32.08
|
-12.1 10^3 cells per microliter
Standard Deviation 46.27
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameter: Ery. MCH. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Ery. MCH
|
—
|
0.19 picograms
Standard Deviation 0.775
|
0.51 picograms
Standard Deviation 1.045
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameter: Ery. MCV. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Ery. MCV
|
—
|
1.54 femtoliters
Standard Deviation 2.743
|
2.04 femtoliters
Standard Deviation 3.412
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameter: Erythrocytes and Reticulocytes. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes and Reticulocytes
Erythrocytes
|
—
|
-0.028 10^6 cells per microliter
Standard Deviation 0.269
|
0.024 10^6 cells per microliter
Standard Deviation 0.228
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes and Reticulocytes
Reticulocytes
|
—
|
0.001 10^6 cells per microliter
Standard Deviation 0.012
|
-0.003 10^6 cells per microliter
Standard Deviation 0.012
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameter: Hematocrit. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
|
—
|
0.41 Percentage
Standard Deviation 2.735
|
1.11 Percentage
Standard Deviation 2.403
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected for analysis of following hematology parameter: Hemoglobin. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
|
—
|
0.00 grams per deciliter
Standard Deviation 0.766
|
0.29 grams per deciliter
Standard Deviation 0.827
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Urine samples were collected for analysis of Urine pH. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=57 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=61 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Urine pH
|
—
|
-0.13 potential of Hydrogen
Standard Deviation 0.788
|
0.18 potential of Hydrogen
Standard Deviation 0.791
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Urine samples were collected for analysis of Urine specific gravity. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=57 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=61 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Urine Specific Gravity
|
—
|
0.002 Ratio
Standard Deviation 0.010
|
0.001 Ratio
Standard Deviation 0.008
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Urine samples were collected for analysis of Urobilinogen. Baseline was defined as Day 1. Change from Baseline was obtained by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=57 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=61 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Urobilinogen
|
—
|
0.07 milligrams per deciliter
Standard Deviation 0.313
|
0.05 milligrams per deciliter
Standard Deviation 0.354
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Vital signs including DBP and SBP was measured by at least 5 minutes of rest with the participant in a quiet setting without distractions (eg, television, cell phones). Blood pressure measurements were taken with the participant in the sitting position. Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=64 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in DBP and SBP
DBP
|
—
|
0.8 Millimeters of mercury
Standard Deviation 6.42
|
0.7 Millimeters of mercury
Standard Deviation 9.48
|
—
|
|
Part 2: Change From Baseline in DBP and SBP
SBP
|
—
|
1.4 Millimeters of mercury
Standard Deviation 15.02
|
0.0 Millimeters of mercury
Standard Deviation 15.57
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Vital signs including respiratory rate was measured by at least 5 minutes of rest with the participant in a quiet setting without distractions (eg, television, cell phones). Blood pressure measurements were taken with the participant in the sitting position. Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=64 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Respiratory Rate
|
—
|
0.1 breaths per minute
Standard Deviation 0.97
|
0.2 breaths per minute
Standard Deviation 0.97
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Vital signs including temperature was measured by at least 5 minutes of rest with the participant in a quiet setting without distractions (eg, television, cell phones). Blood pressure measurements were taken with the participant in the sitting position. Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=64 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Temperature
|
—
|
0.01 degrees Celsius
Standard Deviation 0.489
|
-0.03 degrees Celsius
Standard Deviation 0.461
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
Vital signs including heart rate was measured by at least 5 minutes of rest with the participant in a quiet setting without distractions (eg, television, cell phones). Blood pressure measurements were taken with the participant in the sitting position. Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=64 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Heart Rate
|
—
|
-4.2 Beats per minute
Standard Deviation 8.59
|
-2.1 Beats per minute
Standard Deviation 7.86
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
12-lead ECG measurements was obtained using an ECG machine that automatically calculates the PR interval, QRS duration, QT interval and QTcB. Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in ECG Parameters
PR Interval
|
—
|
-1.6 milliseconds
Standard Deviation 13.17
|
2.1 milliseconds
Standard Deviation 18.32
|
—
|
|
Part 2: Change From Baseline in ECG Parameters
QRS Duration
|
—
|
-2.2 milliseconds
Standard Deviation 13.31
|
-1.4 milliseconds
Standard Deviation 7.71
|
—
|
|
Part 2: Change From Baseline in ECG Parameters
QT Interval
|
—
|
4.2 milliseconds
Standard Deviation 26.29
|
3.9 milliseconds
Standard Deviation 20.28
|
—
|
|
Part 2: Change From Baseline in ECG Parameters
QTcB Interval
|
—
|
-2.0 milliseconds
Standard Deviation 18.01
|
-1.7 milliseconds
Standard Deviation 15.99
|
—
|
SECONDARY outcome
Timeframe: Baseline and Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
12-lead ECG measurements was obtained using an ECG machine that automatically calculates the heart rate. Baseline was defined as the last available value prior to the participant receiving the first study drug infusion on Day 1. Change from Baseline was obtained by subtracting the Baseline value from post-dose visit value.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=63 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in ECG Mean Heart Rate
|
—
|
-1.8 Beats per minute
Standard Deviation 8.87
|
-1.3 Beats per minute
Standard Deviation 7.40
|
—
|
SECONDARY outcome
Timeframe: Up to Day 104Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.
The C-SSRS is an interview-based instrument to systematically assess suicidal ideation and suicidal behavior. Number of participants that have an affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) were reported. The total score ranges from 0 (no ideation present) to 5 (active suicidal ideation with specific plan and intent); higher scores indicate worse symptoms.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=64 Participants
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Active suicidal ideation without any methods without intent to act
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Most recent attempt
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Preparatory acts or behavior
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
First attempt
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Wish to be dead
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Non-specific active suicidal thoughts
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Active suicidal ideation with some intent to act, without specific plan
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Active suicidal ideation with specific plan and intent
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Any suicidal behavior
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Actual attempt
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Interrupted attempt
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Aborted attempt
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Lethal attempt
|
—
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 104Population: Full Analysis Set. This analysis was planned but data was not captured in the database.
A complete physical examination included, at a minimum, assessment of the Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 104Population: Full Analysis Set. This analysis was planned but data was not captured in the database.
The neurological examination assessed mental status, motor and sensory skills, hearing and speech, vision, coordination, and balance. This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29Population: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected at indicated time points for PK analysis of TB006. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=59 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Ctrough of TB006
|
—
|
395.82 micrograms per milliliter
Geometric Coefficient of Variation 35.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected at indicated time points for PK analysis of TB006. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=48 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: t1/2 of TB006
|
—
|
756.78 hours
Geometric Coefficient of Variation 22.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 29Population: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Blood samples were collected at indicated time points for PK analysis of TB006. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Placebo
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=58 Participants
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
|---|---|---|---|---|
|
Part 2: Cmax of TB006
Day 1
|
—
|
339.17 Micrograms per milliliter
Geometric Coefficient of Variation 23.82
|
—
|
—
|
|
Part 2: Cmax of TB006
Day 29
|
—
|
731.55 Micrograms per milliliter
Geometric Coefficient of Variation 25.13
|
—
|
—
|
Adverse Events
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1: TB006 420 mg qw
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: TB006 1000 mg qw
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: TB006 1000 mg qw
Serious events: 4 serious events
Other events: 28 other events
Deaths: 1 deaths
Part 2: Placebo
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 participants at risk
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 participants at risk
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 participants at risk
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
Part 1: Placebo
n=6 participants at risk
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 2: TB006 1000 mg qw
n=63 participants at risk
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
Part 2: Placebo
n=66 participants at risk
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Part 1: TB006 140 Milligrams (mg) Weekly (qw)
n=7 participants at risk
Participants were randomized to receive intravenous infusions of TB006 140 mg weekly for over 1 hour.
|
Part 1: TB006 420 mg qw
n=6 participants at risk
Participants were randomized to receive intravenous infusions of TB006 420 mg weekly for over 1 hour.
|
Part 1: TB006 1000 mg qw
n=6 participants at risk
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
Part 1: Placebo
n=6 participants at risk
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
Part 2: TB006 1000 mg qw
n=63 participants at risk
Participants were randomized to receive intravenous infusions of TB006 1000 mg weekly for over 1 hour.
|
Part 2: Placebo
n=66 participants at risk
Participants were randomized to receive intravenous infusions of matching placebo weekly for over 1 hour.
|
|---|---|---|---|---|---|---|
|
Investigations
Blood glucose increased
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
4.8%
3/63 • Number of events 3 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
7.9%
5/63 • Number of events 5 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
3.0%
2/66 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Investigations
Blood urea increased
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Investigations
Thyroid function test abnormal
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rash
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
3.0%
2/66 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Claustrophobia
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
3.0%
2/66 • Number of events 4 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
3.0%
2/66 • Number of events 2 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/66 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/6 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
0.00%
0/63 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
4.5%
3/66 • Number of events 3 • Up to Day 104
Serious adverse events and non-Serious adverse events were collected in Safety Analysis Set and comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER