Trial Outcomes & Findings for A Study of AZD8233 in Participants With Dyslipidemia. (NCT NCT04823611)
NCT ID: NCT04823611
Last Updated: 2024-12-24
Results Overview
Part B: Change from baseline in LDL-C at week 12. Results are based on Mixed Model Repeated Measures (MMRM) analysis on the log-transformed change from baseline. Log-transformed change from baseline is calculated as the visit value in log minus the baseline value in log. The results from the model are then back transformed. Note: log(week 12 data) - log(baseline data) = log(week12/baseline), which is a ratio
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Baseline to week 12
Results posted on
2024-12-24
Participant Flow
Participant milestones
| Measure |
Part A:AZD8233 90mg
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
AZD8233 medium dose for subcutaneous injection.
|
Part B:AZD8233 15mg
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
22
|
22
|
21
|
8
|
3
|
|
Overall Study
COMPLETED
|
6
|
3
|
21
|
22
|
21
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A:AZD8233 90mg
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
AZD8233 medium dose for subcutaneous injection.
|
Part B:AZD8233 15mg
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of AZD8233 in Participants With Dyslipidemia.
Baseline characteristics by cohort
| Measure |
Part A:AZD8233 90mg
n=8 Participants
AZD8233 for subcutaneous injection.
|
Part A:Placebo
n=3 Participants
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
n=22 Participants
AZD8233 medium dose for subcutaneous injection.
|
Part B:AZD8233 15mg
n=22 Participants
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
n=21 Participants
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
n=8 Participants
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
n=3 Participants
Placebo solution for subcutaneous injection.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.1 Years
STANDARD_DEVIATION 5.38 • n=99 Participants
|
47.0 Years
STANDARD_DEVIATION 11.36 • n=107 Participants
|
60.6 Years
STANDARD_DEVIATION 6.29 • n=206 Participants
|
64.4 Years
STANDARD_DEVIATION 5.50 • n=7 Participants
|
61.9 Years
STANDARD_DEVIATION 7.04 • n=31 Participants
|
52.0 Years
STANDARD_DEVIATION 6.37 • n=30 Participants
|
52.0 Years
STANDARD_DEVIATION 3.61 • n=3 Participants
|
59.6 Years
STANDARD_DEVIATION 7.86 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
33 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
54 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
87 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: Full Analysis Set (Part B only). These data were not pre-specified for parts A and C
Part B: Change from baseline in LDL-C at week 12. Results are based on Mixed Model Repeated Measures (MMRM) analysis on the log-transformed change from baseline. Log-transformed change from baseline is calculated as the visit value in log minus the baseline value in log. The results from the model are then back transformed. Note: log(week 12 data) - log(baseline data) = log(week12/baseline), which is a ratio
Outcome measures
| Measure |
Part B:AZD8233 15mg
n=22 Participants
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
n=21 Participants
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
Part A:AZD8233 90mg
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
n=20 Participants
AZD8233 medium dose for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Part B: Change in LDL-C in Serum at Week 12
|
0.458 Ratio
Interval 0.388 to 0.541
|
0.953 Ratio
Interval 0.806 to 1.128
|
—
|
—
|
—
|
—
|
0.198 Ratio
Interval 0.167 to 0.235
|
SECONDARY outcome
Timeframe: Measurement at baseline and week 12Population: Full Analysis Set (Part B only). These data were not pre-specified for parts A and C
Percentage change from baseline to week 12 in Low-density Lipoprotein Cholesterol (LDL-C) in serum
Outcome measures
| Measure |
Part B:AZD8233 15mg
n=22 Participants
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
n=21 Participants
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
Part A:AZD8233 90mg
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
n=21 Participants
AZD8233 medium dose for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Part B: Percentage Change From Baseline in LDL-C in Serum at Week 12
|
-52.48 % change from baseline
Interval -58.85 to -46.11
|
-3.24 % change from baseline
Interval -9.68 to 3.19
|
—
|
—
|
—
|
—
|
-77.13 % change from baseline
Interval -83.67 to -70.59
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Full Analysis Set (Part B only). These data were not pre-specified for parts A and C
Part B: Change from baseline in PCSK9 in plasma at week 12. Results are based on Mixed Model Repeated Measures (MMRM) analysis on the log-transformed change from baseline. Log-transformed change from baseline is calculated as the visit value in log minus the baseline value in log. The results from the model are then back transformed. Note: log(week 12 data) - log(baseline data) = log(week12/baseline), which is a ratio
Outcome measures
| Measure |
Part B:AZD8233 15mg
n=22 Participants
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
n=21 Participants
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
Part A:AZD8233 90mg
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
n=21 Participants
AZD8233 medium dose for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Part B: Change in PCSK9 in Plasma at Week 12
|
0.296 Ratio
Interval 0.248 to 0.352
|
0.874 Ratio
Interval 0.731 to 1.045
|
—
|
—
|
—
|
—
|
0.066 Ratio
Interval 0.055 to 0.079
|
SECONDARY outcome
Timeframe: Measurement at baseline and week 12Population: Full Analysis Set (Part B only). These data were not pre-specified for parts A and C
Percentage change from baseline to week 12 in proprotein convertase subtilisin/kexin type-9 (PCSK9) in plasma
Outcome measures
| Measure |
Part B:AZD8233 15mg
n=22 Participants
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
n=21 Participants
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
Part A:AZD8233 90mg
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
n=21 Participants
AZD8233 medium dose for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Part B: Percentage Change From Baseline in PCSK9 in Plasma at Week 12
|
-65.07 % change from baseline
Interval -71.03 to -59.12
|
-11.92 % change from baseline
Interval -18.01 to -5.82
|
—
|
—
|
—
|
—
|
-92.91 % change from baseline
Interval -99.0 to -86.82
|
SECONDARY outcome
Timeframe: Day 1 and Day 57Population: Pharmacokinetic Analysis Set (Parts A and C only). These data were not pre-specified for part B
Area Under the plasma concentration time curve from time 0 to time 24 hours
Outcome measures
| Measure |
Part B:AZD8233 15mg
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
n=8 Participants
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
Part A:AZD8233 90mg
n=8 Participants
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
AZD8233 medium dose for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Part A & Part C: AUC (0-24) of AZD8233
Day 1
|
—
|
—
|
3906 h.ng/mL
Geometric Coefficient of Variation 26.56
|
—
|
5736 h.ng/mL
Geometric Coefficient of Variation 53.55
|
—
|
—
|
|
Part A & Part C: AUC (0-24) of AZD8233
Day 57
|
—
|
—
|
3493 h.ng/mL
Geometric Coefficient of Variation 32.47
|
—
|
5377 h.ng/mL
Geometric Coefficient of Variation 50.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 57Population: Pharmacokinetic Analysis Set (Parts A and C only). These data were not pre-specified for part B
Maximum plasma concentration
Outcome measures
| Measure |
Part B:AZD8233 15mg
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
n=8 Participants
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
Part A:AZD8233 90mg
n=8 Participants
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
AZD8233 medium dose for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Part A & Part C: Cmax of AZD8233
Day 57
|
—
|
—
|
781.2 ng/mL
Geometric Coefficient of Variation 50.34
|
—
|
1271 ng/mL
Geometric Coefficient of Variation 70.63
|
—
|
—
|
|
Part A & Part C: Cmax of AZD8233
Day 1
|
—
|
—
|
830.8 ng/mL
Geometric Coefficient of Variation 23.90
|
—
|
1525 ng/mL
Geometric Coefficient of Variation 62.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 57Population: Pharmacokinetic Analysis Set (Parts A and C only). These data were not pre-specified for part B
Terminal half-life
Outcome measures
| Measure |
Part B:AZD8233 15mg
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
n=8 Participants
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
Part A:AZD8233 90mg
n=8 Participants
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
AZD8233 medium dose for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Part A & Part C: t1/2 of AZD8233
Day 1
|
—
|
—
|
2.751 hours
Geometric Coefficient of Variation 35.94
|
—
|
3.459 hours
Geometric Coefficient of Variation 45.69
|
—
|
—
|
|
Part A & Part C: t1/2 of AZD8233
Day 57
|
—
|
—
|
2.527 hours
Geometric Coefficient of Variation 28.36
|
—
|
2.848 hours
Geometric Coefficient of Variation 44.73
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 57Population: Pharmacokinetic Analysis Set (Parts A and C only). These data were not pre-specified for part B
Apparent plasma clearance
Outcome measures
| Measure |
Part B:AZD8233 15mg
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
n=8 Participants
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
Part A:AZD8233 90mg
n=8 Participants
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
AZD8233 medium dose for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Part A & Part C: CL/F (L/h) of AZD8233
Day 1
|
—
|
—
|
15.31 L/h
Geometric Coefficient of Variation 26.36
|
—
|
15.58 L/h
Geometric Coefficient of Variation 52.84
|
—
|
—
|
|
Part A & Part C: CL/F (L/h) of AZD8233
Day 57
|
—
|
—
|
17.14 L/h
Geometric Coefficient of Variation 32.25
|
—
|
16.62 L/h
Geometric Coefficient of Variation 50.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 57Population: Pharmacokinetic Analysis Set (Parts A and C only). These data were not pre-specified for part B
Apparent Volume of distribution during the terminal phase
Outcome measures
| Measure |
Part B:AZD8233 15mg
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
n=8 Participants
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
Placebo solution for subcutaneous injection.
|
Part A:AZD8233 90mg
n=8 Participants
AZD8233 for subcutaneous injection.
|
Part A:Placebo
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
AZD8233 medium dose for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
Part A & Part C: Vz/F (L)
Day 1
|
—
|
—
|
60.77 L
Geometric Coefficient of Variation 56.66
|
—
|
77.74 L
Geometric Coefficient of Variation 106.7
|
—
|
—
|
|
Part A & Part C: Vz/F (L)
Day 57
|
—
|
—
|
62.49 L
Geometric Coefficient of Variation 56.80
|
—
|
68.30 L
Geometric Coefficient of Variation 58.04
|
—
|
—
|
Adverse Events
Part A:AZD8233 90mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A:Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B:AZD8233 50mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B:AZD8233 15mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B:Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part C: AZD8233 60mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A:AZD8233 90mg
n=8 participants at risk
AZD8233 for subcutaneous injection.
|
Part A:Placebo
n=3 participants at risk
Placebo solution for subcutaneous injection.
|
Part B:AZD8233 50mg
n=22 participants at risk
AZD8233 medium dose for subcutaneous injection.
|
Part B:AZD8233 15mg
n=22 participants at risk
AZD8233 low dose for subcutaneous injection.
|
Part B:Placebo
n=21 participants at risk
Placebo solution for subcutaneous injection.
|
Part C: AZD8233 60mg
n=8 participants at risk
AZD8233 medium dose for subcutaneous injection.
|
Part C: Placebo
n=3 participants at risk
Placebo solution for subcutaneous injection.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 2 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Infections and infestations
COVID-19
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
25.0%
2/8 • Number of events 2 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
75.0%
6/8 • Number of events 6 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
33.3%
1/3 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
33.3%
1/3 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Infections and infestations
Cystitis
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Infections and infestations
Myringitis
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 2 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.5%
1/22 • Number of events 2 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
4.8%
1/21 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
12.5%
1/8 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
12.5%
1/8 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/3 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/22 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/21 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
0.00%
0/8 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
33.3%
1/3 • Number of events 1 • From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.
MedDRA 24.1 for Part A, MedDRA 25.0 for Parts B \& C
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place