Trial Outcomes & Findings for A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers (NCT NCT02005211)
NCT ID: NCT02005211
Last Updated: 2016-11-04
Results Overview
Safety - Number of subjects reporting any adverse events during the study
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
114 participants
Primary outcome timeframe
Day of first dose to follow up
Results posted on
2016-11-04
Participant Flow
Healthy subjects, adult and elderly Japanese vlounteers, male and female (non-fertile); First patient enrolled 24 Dec 2013, last patient completed 29 Jul 2014
Single Japanese Centre: SAD Part 1: 24 young adult subjects in 3 cohorts of 8, 2 placebo and 6 active AZD3293 dose (15 mg, 50 mg, 150 mg); MAD Part 2:16 elderly subjects in 2 Cohorts of 8, randomized 2 placebo and 6 active dose AZD3293 (15 mg, 50 mg) - Only data on subjests enrolled into cohorts was included in the data base for reporting
Participant milestones
| Measure |
Placebo Part 1
Placebo Part 1 - SAD
|
AZD3293 15 mg Part 1
AZD3293 15 mg Part 1 - SAD
|
AZD3293 50 mg Part 1
AZD3293 50 mg Part 1 - SAD
|
AZD3293 150 mg Part 1
AZD3293 150 mg Part 1 - SAD
|
AZD3293 15 mg Part 2
AZD3293 15 mg Part 2 -MAD
|
AZD3293 50 mg Part 2
AZD3293 50 mg Part 2 - MAD
|
Placebo Part 2
Placebo Part 2 - MAD
|
|---|---|---|---|---|---|---|---|
|
Part 1 - Cohorts 1-3 Adult Subjects
STARTED
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
|
Part 1 - Cohorts 1-3 Adult Subjects
COMPLETED
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
|
Part 1 - Cohorts 1-3 Adult Subjects
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 - Elderly Subjects Cohorts 4 & 5
STARTED
|
0
|
0
|
0
|
0
|
6
|
6
|
4
|
|
Part 2 - Elderly Subjects Cohorts 4 & 5
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
6
|
4
|
|
Part 2 - Elderly Subjects Cohorts 4 & 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Part 1
Placebo Part 1 - SAD
|
AZD3293 15 mg Part 1
AZD3293 15 mg Part 1 - SAD
|
AZD3293 50 mg Part 1
AZD3293 50 mg Part 1 - SAD
|
AZD3293 150 mg Part 1
AZD3293 150 mg Part 1 - SAD
|
AZD3293 15 mg Part 2
AZD3293 15 mg Part 2 -MAD
|
AZD3293 50 mg Part 2
AZD3293 50 mg Part 2 - MAD
|
Placebo Part 2
Placebo Part 2 - MAD
|
|---|---|---|---|---|---|---|---|
|
Part 2 - Elderly Subjects Cohorts 4 & 5
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers
Baseline characteristics by cohort
| Measure |
Placebo Part 1
n=6 Participants
Placebo Part 1 - SAD
|
AZD3293 15 mg Part 1
n=6 Participants
AZD3293 15 mg Part 1 - SAD
|
AZD3293 50 mg Part 1
n=6 Participants
AZD3293 50 mg Part 1 - SAD
|
AZD3293 150 mg Part 1
n=6 Participants
AZD3293 150 mg Part 1 - SAD
|
AZD3293 15 mg Part 2
n=6 Participants
AZD3293 15 mg Part 2 -MAD
|
AZD3293 50 mg Part 2
n=6 Participants
AZD3293 50 mg Part 2 - MAD
|
Placebo Part 2
n=4 Participants
Placebo Part 2 - MAD
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Young adult
|
28.8 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
32.2 Years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
23.8 Years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
22.7 Years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
NA Years
STANDARD_DEVIATION NA • n=21 Participants
|
NA Years
STANDARD_DEVIATION NA • n=10 Participants
|
NA Years
STANDARD_DEVIATION NA • n=115 Participants
|
26.9 Years
STANDARD_DEVIATION 7.8 • n=6 Participants
|
|
Age, Continuous
Elderly Adults
|
NA Years
STANDARD_DEVIATION NA • n=5 Participants
|
NA Years
STANDARD_DEVIATION NA • n=7 Participants
|
NA Years
STANDARD_DEVIATION NA • n=5 Participants
|
NA Years
STANDARD_DEVIATION NA • n=4 Participants
|
65.5 Years
STANDARD_DEVIATION 3.8 • n=21 Participants
|
64.2 Years
STANDARD_DEVIATION 5.0 • n=10 Participants
|
60.5 Years
STANDARD_DEVIATION 5.4 • n=115 Participants
|
63.8 Years
STANDARD_DEVIATION 4.8 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
28 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
40 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
40 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day of first dose to follow upPopulation: Safety
Safety - Number of subjects reporting any adverse events during the study
Outcome measures
| Measure |
AZD3293 15 mg Part 1
n=6 Participants
AZD3293 15 mg Part 1 - SAD
|
AZD3293 50 mg Part 1
n=6 Participants
AZD3293 50 mg Part 1 - SAD
|
AZD3293 150 mg Part 1
n=6 Participants
AZD3293 150 mg Part 1 - SAD
|
AZD3293 15 mg Part 2
n=6 Participants
AZD3293 15 mg Part 2 -MAD
|
AZD3293 50 mg Part 2
n=6 Participants
AZD3293 50 mg Part 2 - MAD
|
AZD3293 50 mg Part 2
n=6 Participants
AZD3293 50 mg Part 2 - MAD
|
Placebo Part 2
n=4 Participants
Placebo Part 2 - MAD
|
|---|---|---|---|---|---|---|---|
|
Safety - Adverse Events
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hrPopulation: Pharmacokinetic
Pharmacokinetic maximum concentration
Outcome measures
| Measure |
AZD3293 15 mg Part 1
n=6 Participants
AZD3293 15 mg Part 1 - SAD
|
AZD3293 50 mg Part 1
n=6 Participants
AZD3293 50 mg Part 1 - SAD
|
AZD3293 150 mg Part 1
n=6 Participants
AZD3293 150 mg Part 1 - SAD
|
AZD3293 15 mg Part 2
n=5 Participants
AZD3293 15 mg Part 2 -MAD
|
AZD3293 50 mg Part 2
n=6 Participants
AZD3293 50 mg Part 2 - MAD
|
AZD3293 50 mg Part 2
AZD3293 50 mg Part 2 - MAD
|
Placebo Part 2
Placebo Part 2 - MAD
|
|---|---|---|---|---|---|---|---|
|
PK Cmax - Overall Study
Single dose
|
82.5 ng/mL
Geometric Coefficient of Variation 20.9
|
395 ng/mL
Geometric Coefficient of Variation 24.9
|
1480 ng/mL
Geometric Coefficient of Variation 14.4
|
86.6 ng/mL
Geometric Coefficient of Variation 31.7
|
395 ng/mL
Geometric Coefficient of Variation 38.5
|
—
|
—
|
|
PK Cmax - Overall Study
MAD -Day 10 steady state
|
NA ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
NA ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
NA ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
115 ng/mL
Geometric Coefficient of Variation 29.7
|
465 ng/mL
Geometric Coefficient of Variation 42.2
|
—
|
—
|
|
PK Cmax - Overall Study
MAD - Day 14 steady state
|
NA ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
NA ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
NA ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
119 ng/mL
Geometric Coefficient of Variation 23.3
|
502 ng/mL
Geometric Coefficient of Variation 30.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hrPopulation: healthy Japanese participants
Pharmacokintic Area Under the Curve (0 to t)
Outcome measures
| Measure |
AZD3293 15 mg Part 1
n=6 Participants
AZD3293 15 mg Part 1 - SAD
|
AZD3293 50 mg Part 1
n=6 Participants
AZD3293 50 mg Part 1 - SAD
|
AZD3293 150 mg Part 1
n=6 Participants
AZD3293 150 mg Part 1 - SAD
|
AZD3293 15 mg Part 2
n=5 Participants
AZD3293 15 mg Part 2 -MAD
|
AZD3293 50 mg Part 2
n=6 Participants
AZD3293 50 mg Part 2 - MAD
|
AZD3293 50 mg Part 2
AZD3293 50 mg Part 2 - MAD
|
Placebo Part 2
Placebo Part 2 - MAD
|
|---|---|---|---|---|---|---|---|
|
PK AUC - Overall Study (SAD & MAD Parts)
Single dose
|
839 hr.ng/mL
Geometric Coefficient of Variation 28.1
|
2810 hr.ng/mL
Geometric Coefficient of Variation 17.6
|
10700 hr.ng/mL
Geometric Coefficient of Variation 10.1
|
877 hr.ng/mL
Geometric Coefficient of Variation 12.5
|
3070 hr.ng/mL
Geometric Coefficient of Variation 27.7
|
—
|
—
|
|
PK AUC - Overall Study (SAD & MAD Parts)
MAD -Day 10 Steady state
|
NA hr.ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
NA hr.ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
NA hr.ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
1060 hr.ng/mL
Geometric Coefficient of Variation 18.3
|
3540 hr.ng/mL
Geometric Coefficient of Variation 37.3
|
—
|
—
|
|
PK AUC - Overall Study (SAD & MAD Parts)
MAD -Day 14 Steady state
|
NA hr.ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
NA hr.ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
NA hr.ng/mL
Geometric Coefficient of Variation NA
PART 1 - Single dose
|
1030 hr.ng/mL
Geometric Coefficient of Variation 12.8
|
3280 hr.ng/mL
Geometric Coefficient of Variation 30.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre dose vs Day 14Population: Pharmacodynamic
Biomarker (Abeta 1-40; A beta 1-42) % change from baseline
Outcome measures
| Measure |
AZD3293 15 mg Part 1
n=6 Participants
AZD3293 15 mg Part 1 - SAD
|
AZD3293 50 mg Part 1
n=6 Participants
AZD3293 50 mg Part 1 - SAD
|
AZD3293 150 mg Part 1
n=6 Participants
AZD3293 150 mg Part 1 - SAD
|
AZD3293 15 mg Part 2
n=6 Participants
AZD3293 15 mg Part 2 -MAD
|
AZD3293 50 mg Part 2
n=5 Participants
AZD3293 50 mg Part 2 - MAD
|
AZD3293 50 mg Part 2
n=6 Participants
AZD3293 50 mg Part 2 - MAD
|
Placebo Part 2
n=4 Participants
Placebo Part 2 - MAD
|
|---|---|---|---|---|---|---|---|
|
Biomarker
Plasma Abeta(1-40), Day 1
|
-9.03 % change from baseline
Standard Deviation 14.3
|
-69.6 % change from baseline
Standard Deviation 8.36
|
-75.8 % change from baseline
Standard Deviation 6.34
|
-62.7 % change from baseline
Standard Deviation 37.6
|
-65.9 % change from baseline
Standard Deviation 4.54
|
-70.2 % change from baseline
Standard Deviation 3.76
|
-7.4 % change from baseline
Standard Deviation 3.89
|
|
Biomarker
Plasma Abeta (1-42) Day 1
|
4.80 % change from baseline
Standard Deviation 9.78
|
-58.3 % change from baseline
Standard Deviation 22.3
|
-71.9 % change from baseline
Standard Deviation 9.74
|
-79.4 % change from baseline
Standard Deviation 4.84
|
-73.7 % change from baseline
Standard Deviation 4.03
|
-77.1 % change from baseline
Standard Deviation 5.31
|
12.4 % change from baseline
Standard Deviation 16.9
|
|
Biomarker
Plasma Abeta(1-40) Day 14
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
-74.7 % change from baseline
Standard Deviation 5.28
|
-77.0 % change from baseline
Standard Deviation 3.36
|
-5.1 % change from baseline
Standard Deviation 8.56
|
|
Biomarker
CSF Abeta(1-40) Day 14
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
-50.4 % change from baseline
Standard Deviation 7.49
|
-76.6 % change from baseline
Standard Deviation 3.96
|
-8.0 % change from baseline
Standard Deviation 22.7
|
|
Biomarker
CSF Abeta(1-42) Day 14
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
-63.2 % change from baseline
Standard Deviation 9.12
|
-79.3 % change from baseline
Standard Deviation 4.69
|
1.75 % change from baseline
Standard Deviation 21.9
|
|
Biomarker
Plasma Abeta(1-42) Day 14
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
NA % change from baseline
Standard Deviation NA
PART 1 - Single dose
|
-77.6 % change from baseline
Standard Deviation 4.73
|
-78.6 % change from baseline
Standard Deviation 4.27
|
15.9 % change from baseline
Standard Deviation 19.9
|
Adverse Events
Placebo Part 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AZD3293 15 mg Part 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AZD3293 50 mg Part 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AZD3293 150 mg Part 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AZD3293 15 mg Part 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AZD3293 50 mg Part 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Part 2
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 |
Placebo Part 1
n=6 participants at risk
Placebo Part 1 - SAD
|
AZD3293 15 mg Part 1
n=6 participants at risk
AZD3293 15 mg Part 1 - SAD
|
AZD3293 50 mg Part 1
n=6 participants at risk
AZD3293 50 mg Part 1 - SAD
|
AZD3293 150 mg Part 1
n=6 participants at risk
AZD3293 150 mg Part 1 - SAD
|
AZD3293 15 mg Part 2
n=6 participants at risk
AZD3293 15 mg Part 2 -MAD
|
AZD3293 50 mg Part 2
n=6 participants at risk
AZD3293 50 mg Part 2 - MAD
|
Placebo Part 2
n=4 participants at risk
Placebo Part 2 - MAD
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
16.7%
1/6 • Number of events 1 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
33.3%
2/6 • Number of events 2 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
25.0%
1/4 • Number of events 1 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
|
Infections and infestations
Nasopharengitis
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
16.7%
1/6 • Number of events 1 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
16.7%
1/6 • Number of events 1 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/4 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
16.7%
1/6 • Number of events 1 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/4 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
|
Nervous system disorders
Dizziness postural
|
16.7%
1/6 • Number of events 1 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/6 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
0.00%
0/4 • up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60