Trial Outcomes & Findings for AZD8108 SAD/MAD in Healthy Volunteers (NCT NCT02248818)
NCT ID: NCT02248818
Last Updated: 2017-04-07
Results Overview
Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
258 participants
Primary outcome timeframe
Day -1 to 7 days after last dose
Results posted on
2017-04-07
Participant Flow
Healthy Adult volunteer study, Part 1: SAD: single ascending dose cohorts, followed by Part 2: MAD: multiple ascending dose cohorts. Plan was for each cohort to have 8 subjects, 2 placebo dosed and 6 AZD8108 dosed.
Protocol allowed for 258 subjects to be screened, only 155 subjects were screened before all cohorts for the study were filled and recruitment ended.
Participant milestones
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
Screen
Screen - no treatment
|
|---|---|---|---|---|---|---|---|---|---|
|
Screening
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
155
|
|
Screening
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
48
|
|
Screening
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
107
|
|
Randomised Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
8
|
6
|
4
|
0
|
|
Randomised Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
0
|
6
|
4
|
0
|
|
Randomised Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
Screen
Screen - no treatment
|
|---|---|---|---|---|---|---|---|---|---|
|
Screening
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
|
Screening
Study fully enrolled
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
|
Screening
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
73
|
|
Screening
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Screening
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
|
Randomised Study
Administrative - randomization error
|
0
|
0
|
0
|
0
|
0
|
8
|
0
|
0
|
0
|
Baseline Characteristics
AZD8108 SAD/MAD in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
AZD8108 20 mg - SAD
n=6 Participants
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg - SAD
n=6 Participants
AZD8108 60 mg SAD, Cohort 2
|
AZD8108 95 mg - SAD
n=6 Participants
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
n=6 Participants
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
n=8 Participants
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
n=4 Participants
Placebo MAD, pooled across Cohorts 5 \& 7
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.0 Years
STANDARD_DEVIATION 10.81 • n=5 Participants
|
36.3 Years
STANDARD_DEVIATION 12.55 • n=7 Participants
|
38.7 Years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
38.0 Years
STANDARD_DEVIATION 10.53 • n=4 Participants
|
36.7 Years
STANDARD_DEVIATION 7.89 • n=21 Participants
|
35.4 Years
STANDARD_DEVIATION 10.31 • n=8 Participants
|
31.2 Years
STANDARD_DEVIATION 2.64 • n=8 Participants
|
39.3 Years
STANDARD_DEVIATION 9.22 • n=24 Participants
|
36.0 Years
STANDARD_DEVIATION 9.62 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day -1 to 7 days after last dosePopulation: Safety population
Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal
Outcome measures
| Measure |
AZD8108 20 mg SAD
n=6 Participants
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
n=6 Participants
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
n=6 Participants
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
n=6 Participants
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
n=8 Participants
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
n=4 Participants
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dosePopulation: Pharmacokinetic Population (those dosed with AZD8108)
Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108
Outcome measures
| Measure |
AZD8108 20 mg SAD
n=6 Participants
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
n=6 Participants
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
n=6 Participants
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
n=8 Participants
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108
|
726 hours*ng/mL
Geometric Coefficient of Variation 22.4
|
2651 hours*ng/mL
Geometric Coefficient of Variation 17.1
|
4533 hours*ng/mL
Geometric Coefficient of Variation 11.3
|
—
|
2160 hours*ng/mL
Geometric Coefficient of Variation 37.8
|
4318 hours*ng/mL
Geometric Coefficient of Variation 13.2
|
4597 hours*ng/mL
Geometric Coefficient of Variation 21.8
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dosePopulation: Pharmacokinetic Population (those dosed with AZD8108)
Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 \& 7, Cohort 6 did not reach Day 6
Outcome measures
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108
|
—
|
—
|
—
|
—
|
2061 hours*ng/mL
Geometric Coefficient of Variation 34.7
|
—
|
4408 hours*ng/mL
Geometric Coefficient of Variation 26.3
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dosePopulation: Pharmacokinetic Population (those dosed with AZD8108)
Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 \& 7, Cohort 6 did not reach Day 12
Outcome measures
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108
|
—
|
—
|
—
|
—
|
2837 hours*ng/mL
Geometric Coefficient of Variation 47.6
|
—
|
6733 hours*ng/mL
Geometric Coefficient of Variation 30.2
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dosePopulation: Pharmacokinetic Population (those dosed with AZD8108)
Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 \& 7, Cohort 6 dod not reach Day 12
Outcome measures
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108
|
—
|
—
|
—
|
—
|
2191 hours*ng/mL
Geometric Coefficient of Variation 38.1
|
—
|
4670 hours*ng/mL
Geometric Coefficient of Variation 20.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dosePopulation: Pharmacokinetic Population (those dosed with AZD8108)
Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108
Outcome measures
| Measure |
AZD8108 20 mg SAD
n=6 Participants
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
n=6 Participants
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
n=6 Participants
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
n=8 Participants
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108
|
50.1 ng/mL
Geometric Coefficient of Variation 22.4
|
148 ng/mL
Geometric Coefficient of Variation 19.3
|
264 ng/mL
Geometric Coefficient of Variation 17.8
|
—
|
146 ng/mL
Geometric Coefficient of Variation 27.5
|
287 ng/mL
Geometric Coefficient of Variation 22.7
|
236 ng/mL
Geometric Coefficient of Variation 10.6
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dosePopulation: Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 \& 7
Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 \& 7, Cohort 6 did not reach Day 6
Outcome measures
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108
|
—
|
—
|
—
|
—
|
176 ng/mL
Geometric Coefficient of Variation 23.9
|
—
|
330 ng/mL
Geometric Coefficient of Variation 18.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dosePopulation: Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 \& 7
Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 \& 7, Cohort 6 did not reach Day 12
Outcome measures
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108
|
—
|
—
|
—
|
—
|
197 ng/mL
Geometric Coefficient of Variation 30.4
|
—
|
337 ng/mL
Geometric Coefficient of Variation 11.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dosePopulation: Pharmacokinetic population (subjects dosed with AZD8108)
Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108
Outcome measures
| Measure |
AZD8108 20 mg SAD
n=6 Participants
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
n=6 Participants
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
n=6 Participants
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
n=8 Participants
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108
|
1.75 hours
Interval 1.0 to 3.03
|
2.00 hours
Interval 1.0 to 3.0
|
2.50 hours
Interval 1.0 to 6.0
|
—
|
1.25 hours
Interval 1.0 to 4.0
|
1.28 hours
Interval 1.0 to 3.0
|
2.55 hours
Interval 1.52 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dosePopulation: Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed
Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3)
Outcome measures
| Measure |
AZD8108 20 mg SAD
n=5 Participants with urine volume data
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
n=6 Participants with urine volume data
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
n=5 Participants with urine volume data
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108
|
48.8 Percent
Geometric Coefficient of Variation 55.2
|
33.8 Percent
Geometric Coefficient of Variation 30.1
|
38.8 Percent
Geometric Coefficient of Variation 8.24
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dosePopulation: Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed
Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 \& 7, Cohort 6 did not reach day 12
Outcome measures
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108
|
—
|
—
|
—
|
—
|
49.4 Percent
Geometric Coefficient of Variation 28.1
|
—
|
30.2 Percent
Geometric Coefficient of Variation 35.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dosePopulation: Pharmacokinetic population (subjects dosed with AZD8108)
Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 \& 7, Cohort 6 did not reach day 12
Outcome measures
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108
|
—
|
—
|
—
|
—
|
1.75 hours
Interval 0.5 to 2.0
|
—
|
1.80 hours
Interval 1.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Day 12 compared to Day 1Population: Pharmacokinetic population, MAD Cohorts 5 \& 7
Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 \& 7, cohort 6 did not reach day 12 \[accumulation index (Day 6 or 12 /Day1)\]
Outcome measures
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD
Day 6
|
—
|
—
|
—
|
—
|
1.30 ratio
Standard Deviation 0.181
|
—
|
1.37 ratio
Standard Deviation 0.224
|
—
|
|
Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD
Day 12
|
—
|
—
|
—
|
—
|
1.39 ratio
Standard Deviation 0.254
|
—
|
1.44 ratio
Standard Deviation 0.165
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 hours after dosePopulation: Safety population
EEG parameter (DAY 1) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) - to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction relative to placebo would be of interest
Outcome measures
| Measure |
AZD8108 20 mg SAD
n=6 Participants
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
n=6 Participants
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
n=6 Participants
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
n=6 Participants
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
n=8 Participants
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
n=4 Participants
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
0.5 hours after dose
|
-0.069 uV2
Standard Deviation 0.3715
|
-0.272 uV2
Standard Deviation 0.2422
|
-0.166 uV2
Standard Deviation 0.1880
|
.0141 uV2
Standard Deviation 0.2358
|
-0.343 uV2
Standard Deviation 0.3348
|
0.087 uV2
Standard Deviation 0.3979
|
-0.154 uV2
Standard Deviation 0.2555
|
0.128 uV2
Standard Deviation 0.5069
|
|
EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
1 hour after dose
|
0.101 uV2
Standard Deviation 0.2638
|
-0.238 uV2
Standard Deviation 0.4504
|
-0.140 uV2
Standard Deviation 0.2520
|
-0.003 uV2
Standard Deviation 0.1467
|
-0.109 uV2
Standard Deviation 0.5843
|
0.092 uV2
Standard Deviation 0.3466
|
-0.063 uV2
Standard Deviation 0.2291
|
-0.121 uV2
Standard Deviation 0.2005
|
|
EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
1.5 hours after dose
|
-0.113 uV2
Standard Deviation 0.2616
|
-0.161 uV2
Standard Deviation 0.6017
|
-0.069 uV2
Standard Deviation 0.2095
|
0.097 uV2
Standard Deviation 0.3402
|
0.211 uV2
Standard Deviation 0.5514
|
-0.052 uV2
Standard Deviation 0.3888
|
0.016 uV2
Standard Deviation 0.3687
|
0.313 uV2
Standard Deviation 0.2701
|
|
EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
2 hours after dose
|
0.244 uV2
Standard Deviation 0.2577
|
-0.347 uV2
Standard Deviation 0.3231
|
-0.080 uV2
Standard Deviation 0.2324
|
-0.086 uV2
Standard Deviation 0.2350
|
-0.303 uV2
Standard Deviation 0.4675
|
-0.142 uV2
Standard Deviation 0.2639
|
-0.097 uV2
Standard Deviation 0.2185
|
0.019 uV2
Standard Deviation 0.2661
|
|
EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
3 hours after dose
|
0.214 uV2
Standard Deviation 0.2120
|
-0.254 uV2
Standard Deviation 0.2461
|
-0.108 uV2
Standard Deviation 0.1569
|
0.126 uV2
Standard Deviation 0.1181
|
-0.369 uV2
Standard Deviation 0.4360
|
0.058 uV2
Standard Deviation 0.4186
|
0.011 uV2
Standard Deviation 0.3292
|
0.247 uV2
Standard Deviation 0.4936
|
|
EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
5 hours after dose
|
-0.225 uV2
Standard Deviation 0.1615
|
-0.454 uV2
Standard Deviation 0.2641
|
-0.014 uV2
Standard Deviation 0.1025
|
0.138 uV2
Standard Deviation 0.3071
|
-0.514 uV2
Standard Deviation 0.4117
|
-0.073 uV2
Standard Deviation 0.3506
|
-0.25 uV2
Standard Deviation 0.2971
|
-0.151 uV2
Standard Deviation 0.2954
|
|
EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
8 hours after dose
|
0.222 uV2
Standard Deviation 0.5150
|
-0.263 uV2
Standard Deviation 0.1219
|
-0.086 uV2
Standard Deviation 0.3075
|
0.091 uV2
Standard Deviation 0.4193
|
-0.125 uV2
Standard Deviation 0.4958
|
-0.169 uV2
Standard Deviation 0.3217
|
-0.124 uV2
Standard Deviation 0.3209
|
0.034 uV2
Standard Deviation 0.3623
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 hours after dosePopulation: Safety population
EEG parameter (DAY 6) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 \& 7, Cohort 6 did not reach Day 6; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo was of interest
Outcome measures
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
n=4 Participants
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
Pre-dose Day 6 dose
|
—
|
—
|
—
|
—
|
-0.167 uV2
Standard Deviation 0.3959
|
—
|
0.080 uV2
Standard Deviation 0.4827
|
0.128 uV2
Standard Deviation 0.3311
|
|
EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
0.5 hours after dose
|
—
|
—
|
—
|
—
|
-0.514 uV2
Standard Deviation 0.3729
|
—
|
0.131 uV2
Standard Deviation 0.3518
|
0.384 uV2
Standard Deviation 0.7434
|
|
EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
1 hour after dose
|
—
|
—
|
—
|
—
|
-0.322 uV2
Standard Deviation 0.6343
|
—
|
0.063 uV2
Standard Deviation 0.2129
|
-0.123 uV2
Standard Deviation 0.3713
|
|
EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
1.5 hours after dose
|
—
|
—
|
—
|
—
|
-0.353 uV2
Standard Deviation 0.2722
|
—
|
0.109 uV2
Standard Deviation 0.0729
|
0.375 uV2
Standard Deviation 0.5060
|
|
EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
2 hours after dose
|
—
|
—
|
—
|
—
|
-0.460 uV2
Standard Deviation 0.2219
|
—
|
0.279 uV2
Standard Deviation 0.5172
|
0.223 uV2
Standard Deviation 0.3813
|
|
EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
3 hours after dose
|
—
|
—
|
—
|
—
|
-0.263 uV2
Standard Deviation 0.4014
|
—
|
0.016 uV2
Standard Deviation 0.1550
|
0.435 uV2
Standard Deviation 0.3796
|
|
EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
5 hours after dose
|
—
|
—
|
—
|
—
|
-0.350 uV2
Standard Deviation 0.7782
|
—
|
0.031 uV2
Standard Deviation 0.2103
|
-0.018 uV2
Standard Deviation 0.6197
|
|
EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction
8 hours after dose
|
—
|
—
|
—
|
—
|
-0.454 uV2
Standard Deviation 0.4568
|
—
|
-0.028 uV2
Standard Deviation 0.3062
|
0.271 uV2
Standard Deviation 0.3849
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 hours after dosePopulation: Safety population
EEG parameter (DAY 12) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 \& 7 , Cohort 6 did not reach Day 12; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo would be of interest
Outcome measures
| Measure |
AZD8108 20 mg SAD
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 Participants
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 Participants
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
n=4 Participants
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction
3 hours post dose
|
—
|
—
|
—
|
—
|
-0.119 uV2
Standard Deviation 0.6208
|
—
|
-0.024 uV2
Standard Deviation 0.2590
|
0.234 uV2
Standard Deviation 0.3109
|
|
EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction
Pre dose Day 12
|
—
|
—
|
—
|
—
|
-0.075 uV2
Standard Deviation 0.5040
|
—
|
-0.065 uV2
Standard Deviation 0.1789
|
0.015 uV2
Standard Deviation 0.1749
|
|
EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction
0.5 hours post dose
|
—
|
—
|
—
|
—
|
-0.309 uV2
Standard Deviation 0.7025
|
—
|
-0.134 uV2
Standard Deviation 0.2459
|
0.334 uV2
Standard Deviation 0.3440
|
|
EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction
1 hours post dose
|
—
|
—
|
—
|
—
|
0.193 uV2
Standard Deviation 1.4967
|
—
|
-0.107 uV2
Standard Deviation 0.1970
|
0.253 uV2
Standard Deviation 0.3448
|
|
EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction
1.5 hours post dose
|
—
|
—
|
—
|
—
|
0.073 uV2
Standard Deviation 0.9299
|
—
|
-0.062 uV2
Standard Deviation 0.1783
|
0.373 uV2
Standard Deviation 0.3358
|
|
EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction
2 hours post dose
|
—
|
—
|
—
|
—
|
-0.207 uV2
Standard Deviation 0.6381
|
—
|
-0.087 uV2
Standard Deviation 0.3025
|
-0.046 uV2
Standard Deviation 0.2830
|
|
EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction
5 hours post dose
|
—
|
—
|
—
|
—
|
-0.506 uV2
Standard Deviation 0.4329
|
—
|
0.040 uV2
Standard Deviation 0.1775
|
0.090 uV2
Standard Deviation 0.4258
|
|
EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction
8 hours post dose
|
—
|
—
|
—
|
—
|
0.022 uV2
Standard Deviation 1.0703
|
—
|
-0.048 uV2
Standard Deviation 0.0975
|
0.178 uV2
Standard Deviation 0.2510
|
Adverse Events
AZD8108 20 mg SAD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AZD8108 60 mg SAD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AZD8108 95 mg SAD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo SAD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AZD8108 50 mg MAD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AZD8108 90 mg MAD (6)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AZD8108 90 mg MAD (7)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo MAD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZD8108 20 mg SAD
n=6 participants at risk
AZD8108 20 mg SAD, Cohort 1
|
AZD8108 60 mg SAD
n=6 participants at risk
AZD8106 60 mg SAD, Cohort 2
|
AZD8108 95 mg SAD
n=6 participants at risk
AZD8108 95 mg SAD, Cohort 3
|
Placebo SAD
n=6 participants at risk
Placebo SAD, pooled across Cohorts 1 - 3
|
AZD8108 50 mg MAD
n=6 participants at risk
AZD8108 50 mg MAD, Cohort 5
|
AZD8108 90 mg MAD (6)
n=8 participants at risk
AZD8108 90 mg MAD, Cohort 6
|
AZD8108 90 mg MAD (7)
n=6 participants at risk
AZD8108 90 mg MAD, Cohort 7
|
Placebo MAD
n=4 participants at risk
Placebo MAD, pooled across Cohorts 5 \& 7
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
25.0%
1/4 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Nervous system disorders
Dysguesia
|
100.0%
6/6 • Number of events 6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
33.3%
2/6 • Number of events 2 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
33.3%
2/6 • Number of events 2 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
12.5%
1/8 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
50.0%
2/4 • Number of events 2 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
33.3%
2/6 • Number of events 2 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Psychiatric disorders
Halucination, visual
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Psychiatric disorders
Irritability
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
12.5%
1/8 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
General disorders
Chest Pain
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
25.0%
1/4 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
25.0%
1/4 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
25.0%
1/4 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/6 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/8 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
16.7%
1/6 • Number of events 1 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
0.00%
0/4 • SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60