Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects (NCT NCT02632526)

NCT ID: NCT02632526

Last Updated: 2019-03-21

Results Overview

To assess the safety and tolerability of AZD5718 following oral administration of SAD (Part A) and MAD (Part B).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 96 participants
• Primary outcome timeframe: From screening to last followup visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B)
• Results posted on: 2019-03-21

Participant Flow

This study was conducted on 96 healthy male participants at a single center: PAREXEL Early Phase Clinical Unit - London. This study consisted of 2 parts: Part A - single ascending dose (SAD) and Part B - multiple ascending dose (MAD).

Screening period was from Day -28 and Day -1. Participants signed informed consent form; demographic data, medical history and concomitant medication details were collected; weight, height and body mass index were measured; inclusion/exclusion criteria were checked, serology and screening of urinary drugs of abuse, alcohol and cotinine were done

Participant milestones

Measure	Part A (Amorphous Suspension) Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)
Overall Study STARTED	36	12	24	12	4	8
Overall Study COMPLETED	36	12	24	12	4	8
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.

Baseline characteristics by cohort

Measure	Part A (Amorphous Suspension) n=36 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=12 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=24 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=12 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=4 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=8 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	Total n=96 Participants Total of all reporting groups
Age, Continuous Part A (Amorphous Suspension)	34.3 Years STANDARD_DEVIATION 8.85 • n=36 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	—	—	34.3 Years STANDARD_DEVIATION 8.85 • n=36 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Age, Continuous Part A (Crystalline Suspension)	—	33.2 Years STANDARD_DEVIATION 11.64 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	—	33.2 Years STANDARD_DEVIATION 11.64 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Age, Continuous Part B (Amorphous Suspension)	—	—	35.5 Years STANDARD_DEVIATION 7.32 • n=24 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	35.5 Years STANDARD_DEVIATION 7.32 • n=24 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Age, Continuous Placebo - Part A (Amorphous Suspension)	—	—	—	34.9 Years STANDARD_DEVIATION 10.23 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	34.9 Years STANDARD_DEVIATION 10.23 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Age, Continuous Placebo - Part A (Crystalline Suspension)	—	—	—	—	33.3 Years STANDARD_DEVIATION 5.62 • n=4 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	33.3 Years STANDARD_DEVIATION 5.62 • n=4 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Age, Continuous Placebo - Part B (Amorphous Suspension)	—	—	—	—	—	38.3 Years STANDARD_DEVIATION 5.31 • n=8 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	38.3 Years STANDARD_DEVIATION 5.31 • n=8 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Sex: Female, Male Female	0 Participants n=36 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants	0 Participants n=12 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=96 Participants
Sex: Female, Male Male	36 Participants n=36 Participants	12 Participants n=12 Participants	24 Participants n=24 Participants	12 Participants n=12 Participants	4 Participants n=4 Participants	8 Participants n=8 Participants	96 Participants n=96 Participants
Race/Ethnicity, Customized White	24 Participants n=36 Participants	9 Participants n=12 Participants	20 Participants n=24 Participants	9 Participants n=12 Participants	2 Participants n=4 Participants	5 Participants n=8 Participants	69 Participants n=96 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=36 Participants	1 Participants n=12 Participants	1 Participants n=24 Participants	2 Participants n=12 Participants	1 Participants n=4 Participants	0 Participants n=8 Participants	12 Participants n=96 Participants
Race/Ethnicity, Customized Asian	4 Participants n=36 Participants	1 Participants n=12 Participants	3 Participants n=24 Participants	1 Participants n=12 Participants	0 Participants n=4 Participants	2 Participants n=8 Participants	11 Participants n=96 Participants
Race/Ethnicity, Customized Other: Mixed: Black And White	1 Participants n=36 Participants	1 Participants n=12 Participants	0 Participants n=24 Participants	0 Participants n=12 Participants	1 Participants n=4 Participants	1 Participants n=8 Participants	4 Participants n=96 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=36 Participants	1 Participants n=12 Participants	1 Participants n=24 Participants	0 Participants n=12 Participants	1 Participants n=4 Participants	1 Participants n=8 Participants	5 Participants n=96 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	35 Participants n=36 Participants	11 Participants n=12 Participants	23 Participants n=24 Participants	12 Participants n=12 Participants	3 Participants n=4 Participants	7 Participants n=8 Participants	91 Participants n=96 Participants
Height Part A (Amorphous Suspension)	179.0 Centimeter STANDARD_DEVIATION 6.32 • n=36 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	—	—	179.0 Centimeter STANDARD_DEVIATION 6.32 • n=36 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Height Part A (Crystalline Suspension)	—	180.9 Centimeter STANDARD_DEVIATION 6.95 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	—	180.9 Centimeter STANDARD_DEVIATION 6.95 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Height Part B (Amorphous Suspension)	—	—	178.0 Centimeter STANDARD_DEVIATION 7.07 • n=24 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	178.0 Centimeter STANDARD_DEVIATION 7.07 • n=24 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Height Placebo - Part A (Amorphous Suspension)	—	—	—	176.3 Centimeter STANDARD_DEVIATION 5.33 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	176.3 Centimeter STANDARD_DEVIATION 5.33 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Height Placebo - Part A (Crystalline Suspension)	—	—	—	—	174.3 Centimeter STANDARD_DEVIATION 3.30 • n=4 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	174.3 Centimeter STANDARD_DEVIATION 3.30 • n=4 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Height Placebo - Part B (Amorphous Suspension)	—	—	—	—	—	175.5 Centimeter STANDARD_DEVIATION 7.37 • n=8 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	175.5 Centimeter STANDARD_DEVIATION 7.37 • n=8 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Weight Part A (Amorphous Suspension)	79.24 Kilogram STANDARD_DEVIATION 10.982 • n=36 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	—	—	79.24 Kilogram STANDARD_DEVIATION 10.982 • n=36 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Weight Part A (Crystalline Suspension)	—	74.89 Kilogram STANDARD_DEVIATION 5.450 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	—	74.89 Kilogram STANDARD_DEVIATION 5.450 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Weight Part B (Amorphous Suspension)	—	—	77.95 Kilogram STANDARD_DEVIATION 10.369 • n=24 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	77.95 Kilogram STANDARD_DEVIATION 10.369 • n=24 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Weight Placebo - Part A (Amorphous Suspension)	—	—	—	76.70 Kilogram STANDARD_DEVIATION 9.547 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	76.70 Kilogram STANDARD_DEVIATION 9.547 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Weight Placebo - Part A (Crystalline Suspension)	—	—	—	—	80.50 Kilogram STANDARD_DEVIATION 2.647 • n=4 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	80.50 Kilogram STANDARD_DEVIATION 2.647 • n=4 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Weight Placebo - Part B (Amorphous Suspension)	—	—	—	—	—	74.34 Kilogram STANDARD_DEVIATION 5.532 • n=8 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	74.34 Kilogram STANDARD_DEVIATION 5.532 • n=8 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Body mass index (BMI) Part A (Amorphous Suspension)	24.71 Kilogram/square meter STANDARD_DEVIATION 3.014 • n=36 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	—	—	24.71 Kilogram/square meter STANDARD_DEVIATION 3.014 • n=36 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Body mass index (BMI) Part A (Crystalline Suspension)	—	22.94 Kilogram/square meter STANDARD_DEVIATION 2.265 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	—	22.94 Kilogram/square meter STANDARD_DEVIATION 2.265 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Body mass index (BMI) Part B (Amorphous Suspension)	—	—	24.56 Kilogram/square meter STANDARD_DEVIATION 2.456 • n=24 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	—	24.56 Kilogram/square meter STANDARD_DEVIATION 2.456 • n=24 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Body mass index (BMI) Placebo - Part A (Amorphous Suspension)	—	—	—	24.68 Kilogram/square meter STANDARD_DEVIATION 2.764 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	—	24.68 Kilogram/square meter STANDARD_DEVIATION 2.764 • n=12 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Body mass index (BMI) Placebo - Part A (Crystalline Suspension)	—	—	—	—	26.55 Kilogram/square meter STANDARD_DEVIATION 1.634 • n=4 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	—	26.55 Kilogram/square meter STANDARD_DEVIATION 1.634 • n=4 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.
Body mass index (BMI) Placebo - Part B (Amorphous Suspension)	—	—	—	—	—	24.14 Kilogram/square meter STANDARD_DEVIATION 1.133 • n=8 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.	24.14 Kilogram/square meter STANDARD_DEVIATION 1.133 • n=8 Participants • The number analyzed in row differs from overall since the data for Part A (Amorphous Suspension), Part A (Crystalline Suspension), Part B (Amorphous Suspension), Placebo - Part A (Amorphous Suspension), Placebo - Part A (Crystalline Suspension), Placebo - Part B (Amorphous Suspension) are presented in different rows.

PRIMARY outcome

Timeframe: From screening to last followup visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B)

Population: All randomized subjects who received at least 1 dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.

To assess the safety and tolerability of AZD5718 following oral administration of SAD (Part A) and MAD (Part B).

Outcome measures

Measure	Part A (Amorphous Suspension) n=36 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=12 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=24 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=12 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=4 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=8 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Safety and Tolerability of AZD5718 by Assessment of the Number of Participants With Adverse Events Following Oral Administration of SAD (Part A) and MAD (Part B). Any SAE (including events with outcome = death)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Safety and Tolerability of AZD5718 by Assessment of the Number of Participants With Adverse Events Following Oral Administration of SAD (Part A) and MAD (Part B). Any AE with outcome = death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Safety and Tolerability of AZD5718 by Assessment of the Number of Participants With Adverse Events Following Oral Administration of SAD (Part A) and MAD (Part B). Any AE leading to discontinuation of IMP	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
Safety and Tolerability of AZD5718 by Assessment of the Number of Participants With Adverse Events Following Oral Administration of SAD (Part A) and MAD (Part B). Any AE	15 Participants	2 Participants	10 Participants	1 Participants	1 Participants	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess area under the concentration-time curve from time zero extrapolated to infinity and was estimated by AUC(0-last) + Clast/λz (Clast - the last observed quantifiable concentration) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC) for Part A - Amorphous and Crystalline Suspension	376.3 h*nmol/L Geometric Coefficient of Variation 38.09	727.0 h*nmol/L Geometric Coefficient of Variation 15.39	1441 h*nmol/L Geometric Coefficient of Variation 45.26	8462 h*nmol/L Geometric Coefficient of Variation 20.05	18810 h*nmol/L Geometric Coefficient of Variation 42.09	35840 h*nmol/L Geometric Coefficient of Variation 33.71	706.7 h*nmol/L Geometric Coefficient of Variation 24.24	1006 h*nmol/L Geometric Coefficient of Variation 43.72	—	—

SECONDARY outcome

Timeframe: Day 1 of Part B

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the rate and extent of absorption of AZD5718 by evaluation of the area under plasma concentration-time curve from time zero extrapolated to infinity (AUC) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) for Part B - Amorphous Suspension	1087 h*nmol/L Geometric Coefficient of Variation 24.01	3834 h*nmol/L Geometric Coefficient of Variation 40.94	10720 h*nmol/L Geometric Coefficient of Variation 28.80	17010 h*nmol/L Geometric Coefficient of Variation 47.74	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess area under the area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUC(0-last)) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-last)) for Part A - Amorphous and Crystalline Suspension	264.5 h*nmol/L Geometric Coefficient of Variation 87.15	701.5 h*nmol/L Geometric Coefficient of Variation 15.83	1408 h*nmol/L Geometric Coefficient of Variation 47.23	8395 h*nmol/L Geometric Coefficient of Variation 20.61	18740 h*nmol/L Geometric Coefficient of Variation 42.13	35760 h*nmol/L Geometric Coefficient of Variation 33.81	642.9 h*nmol/L Geometric Coefficient of Variation 21.55	933.2 h*nmol/L Geometric Coefficient of Variation 41.61	—	—

SECONDARY outcome

Timeframe: Day 1, Day 9 and Day 10 of Part B

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the rate and extent of absorption of AZD5718 by evaluation of the area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve Over the Dosing Interval (AUC(0-τ)) for Part B - Amorphous Suspension Day 1	1018 h*nmol/L Geometric Coefficient of Variation 22.40	3732 h*nmol/L Geometric Coefficient of Variation 41.19	10350 h*nmol/L Geometric Coefficient of Variation 28.84	16290 h*nmol/L Geometric Coefficient of Variation 48.56	—	—	—	—	—	—
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve Over the Dosing Interval (AUC(0-τ)) for Part B - Amorphous Suspension Day 9	1441 h*nmol/L Geometric Coefficient of Variation 24.92	3312 h*nmol/L Geometric Coefficient of Variation 33.26	13790 h*nmol/L Geometric Coefficient of Variation 20.56	24890 h*nmol/L Geometric Coefficient of Variation 44.20	—	—	—	—	—	—
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve Over the Dosing Interval (AUC(0-τ)) for Part B - Amorphous Suspension Day 10	1386 h*nmol/L Geometric Coefficient of Variation 27.40	5128 h*nmol/L Geometric Coefficient of Variation 46.90	12760 h*nmol/L Geometric Coefficient of Variation 31.00	23170 h*nmol/L Geometric Coefficient of Variation 47.49	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess observed maximum plasma concentration (Cmax) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part A - Amorphous and Crystalline Suspension	27.14 nmol/L Geometric Coefficient of Variation 75.96	81.62 nmol/L Geometric Coefficient of Variation 36.39	170.3 nmol/L Geometric Coefficient of Variation 54.86	2358 nmol/L Geometric Coefficient of Variation 32.89	5052 nmol/L Geometric Coefficient of Variation 45.82	6875 nmol/L Geometric Coefficient of Variation 34.94	54.62 nmol/L Geometric Coefficient of Variation 28.35	80.24 nmol/L Geometric Coefficient of Variation 39.73	—	—

SECONDARY outcome

Timeframe: Day 1, Day 9 and Day 10 (Part B only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the rate and extent of absorption of AZD5718 by evaluation of the observed maximum plasma concentration (Cmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part B - Amorphous Suspension Day 1	167.3 nmol/L Geometric Coefficient of Variation 19.81	846.9 nmol/L Geometric Coefficient of Variation 48.00	2561 nmol/L Geometric Coefficient of Variation 31.72	4933 nmol/L Geometric Coefficient of Variation 47.63	—	—	—	—	—	—
Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part B - Amorphous Suspension Day 9	225.4 nmol/L Geometric Coefficient of Variation 31.70	349.8 nmol/L Geometric Coefficient of Variation 34.99	3372 nmol/L Geometric Coefficient of Variation 22.69	5297 nmol/L Geometric Coefficient of Variation 43.52	—	—	—	—	—	—
Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part B - Amorphous Suspension Day 10	219.8 nmol/L Geometric Coefficient of Variation 31.93	1243 nmol/L Geometric Coefficient of Variation 55.23	3209 nmol/L Geometric Coefficient of Variation 40.01	5693 nmol/L Geometric Coefficient of Variation 59.95	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the time to reach the observed maximum plasma concentration (tmax) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part A - Amorphous and Crystalline Suspension	2.99 Hours Full Range 75.96 • Interval 1.0 to 5.98	1.02 Hours Full Range 36.39 • Interval 1.0 to 2.98	1.00 Hours Full Range 54.86 • Interval 0.5 to 3.03	1.00 Hours Full Range 32.89 • Interval 0.52 to 1.0	1.00 Hours Full Range 45.82 • Interval 0.98 to 2.0	1.51 Hours Full Range 34.94 • Interval 1.0 to 2.0	3.00 Hours Full Range 28.35 • Interval 1.0 to 4.0	1.98 Hours Full Range 39.73 • Interval 1.0 to 5.98	—	—

SECONDARY outcome

Timeframe: Day 1, Day 9 and Day 10 (Part B only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the rate and extent of absorption of AZD5718 by evaluation of the time to reach the observed maximum plasma concentration (tmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part B - Amorphous Suspension Day 1	0.76 Hours Interval 0.5 to 2.0	1.00 Hours Interval 1.0 to 1.0	1.01 Hours Interval 1.0 to 2.0	1.00 Hours Interval 0.98 to 1.0	—	—	—	—	—	—
Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part B - Amorphous Suspension Day 9	1.00 Hours Interval 0.5 to 3.0	3.51 Hours Interval 2.0 to 6.02	0.99 Hours Interval 0.5 to 1.0	2.00 Hours Interval 1.0 to 2.0	—	—	—	—	—	—
Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part B - Amorphous Suspension Day 10	0.50 Hours Interval 0.5 to 1.02	1.00 Hours Interval 0.98 to 1.02	1.00 Hours Interval 1.0 to 1.0	1.49 Hours Interval 1.0 to 3.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess Rate and extent of absorption of AZD5718 by assessment of the half-life associated with terminal slope of a semi-logarithmic plasma concentration-time curve (t½λz) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part A - Amorphous and Crystalline Suspension	11.90 Hours Standard Deviation 5.063 • Interval 1.0 to 5.98	13.14 Hours Standard Deviation 4.684 • Interval 1.0 to 2.98	13.30 Hours Standard Deviation 4.357 • Interval 0.5 to 3.03	14.62 Hours Standard Deviation 5.361 • Interval 0.52 to 1.0	11.62 Hours Standard Deviation 2.198 • Interval 0.98 to 2.0	10.41 Hours Standard Deviation 1.851 • Interval 1.0 to 2.0	19.97 Hours Standard Deviation 6.763 • Interval 1.0 to 4.0	14.18 Hours Standard Deviation 2.653 • Interval 1.0 to 5.98	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 10 (Part B only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the rate and extent of absorption of AZD5718 by evaluation of the half-life associated with terminal slope of a semi-logarithmic plasma concentration-time curve (t½λz) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part B - Amorphous Suspension Day 1 -From sampling time to 24 hrs; not true t½λz	7.450 Hours Standard Deviation 0.8084	5.489 Hours Standard Deviation 1.168	5.920 Hours Standard Deviation 0.5085	6.799 Hours Standard Deviation 2.036	—	—	—	—	—	—
Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part B - Amorphous Suspension Day 10	11.65 Hours Standard Deviation 0.7718	11.29 Hours Standard Deviation 1.432	9.156 Hours Standard Deviation 1.014	10.23 Hours Standard Deviation 3.144	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess rate and extent of absorption of AZD5718 by assessment of the apparent total body clearance after extravascular administration estimated as dose divided by AUC (CL/F) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part A - Amorphous and Crystalline Suspension	157.3 Liters/Hours Standard Deviation 60.18 • Interval 1.0 to 5.98	155.5 Liters/Hours Standard Deviation 22.31 • Interval 1.0 to 2.98	168.1 Liters/Hours Standard Deviation 74.10 • Interval 0.5 to 3.03	80.84 Liters/Hours Standard Deviation 18.41 • Interval 0.52 to 1.0	76.30 Liters/Hours Standard Deviation 29.08 • Interval 0.98 to 2.0	78.88 Liters/Hours Standard Deviation 31.04 • Interval 1.0 to 2.0	324.5 Liters/Hours Standard Deviation 77.99 • Interval 1.0 to 4.0	714.6 Liters/Hours Standard Deviation 292.2 • Interval 1.0 to 5.98	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 10 of Part B

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess rate and extent of absorption of AZD5718 by assessment of the Rate and extent of absorption of AZD5718 by assessment of CL/F estimated as dose divided by AUC (for Day 1 only) and dose divided by AUCτ on Day 10 following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part B - Amorphous Suspension Day 1	126.6 Liter/Hour Standard Deviation 31.39	112.2 Liter/Hour Standard Deviation 45.10	77.96 Liter/Hour Standard Deviation 24.80	85.85 Liter/Hour Standard Deviation 36.98	—	—	—	—	—	—
Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part B - Amorphous Suspension Day 10	99.85 Liter/Hour Standard Deviation 26.40	85.06 Liter/Hour Standard Deviation 35.38	65.65 Liter/Hour Standard Deviation 20.14	63.07 Liter/Hour Standard Deviation 28.39	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess rate and extent of absorption of AZD5718 by assessment of the apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for Part A - Amorphous and Crystalline Suspension	2608 Liters Standard Deviation 447.6 • Interval 1.0 to 5.98	2940 Liters Standard Deviation 1063 • Interval 1.0 to 2.98	3490 Liters Standard Deviation 2433 • Interval 0.5 to 3.03	1770 Liters Standard Deviation 992.9 • Interval 0.52 to 1.0	1264 Liters Standard Deviation 446.6 • Interval 0.98 to 2.0	1189 Liters Standard Deviation 538.9 • Interval 1.0 to 2.0	8801 Liters Standard Deviation 2072 • Interval 1.0 to 4.0	14630 Liters Standard Deviation 5751 • Interval 1.0 to 5.98	—	—

SECONDARY outcome

Timeframe: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the relative bioavailability by AUC between the cohort receiving the crystalline suspension and the corresponding data from the cohort receiving the same dose of the amorphous suspension (Part A only). Crystalline suspension was compared to the reference amorphous suspension.

Note: Geometric mean ratios for crystalline/amorphous suspensions were calculated

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
To Evaluate the Relative Bioavailability Between the Amorphous and Crystalline Form of AZD5718 (Part A) by Assessment of AUC for Part A - Amorphous and Crystalline Suspension	49.1 h*nmol/L 90% Confidence Interval 2433 • Interval 34.0 to 70.7	11.9 h*nmol/L 90% Confidence Interval 992.9 • Interval 8.38 to 16.9	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the relative bioavailability by Cmax between the cohort receiving the crystalline suspension and the corresponding data from the cohort receiving the same dose of the amorphous suspension (Part A only). Crystalline suspension was compared to the reference amorphous suspension.

Note: Geometric mean ratios for crystalline/amorphous suspensions were calculated

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
To Evaluate the Relative Bioavailability Between the Amorphous and Crystalline Form of AZD5718 (Part A) by Assessment of Cmax for Part A - Amorphous and Crystalline Suspension	32.1 nmol/L 90% Confidence Interval 2433 • Interval 20.8 to 49.4	3.40 nmol/L 90% Confidence Interval 992.9 • Interval 2.35 to 4.92	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 9 (Part B only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess rate and extent of absorption of AZD5718 by assessment of the Rate and extent of absorption of AZD5718 by assessment of accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B) Accumulation ratio calculated as AUC0-τ Day 10/AUC0-τ Day 1 (first dose) for Part B under fasted condition and presented values for Day 10

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Accumulation Ratio for AUC(0-τ) (RAC AUC(0-τ)) for Part B - Amorphous Suspension	1.368 Ratio Interval 1.13 to 1.57	1.387 Ratio Interval 1.02 to 1.56	1.253 Ratio Interval 0.848 to 1.48	1.444 Ratio Interval 1.19 to 1.92	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 and Day 9 (Part B only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the rate and extent of absorption of AZD5718 by evaluation of accumulation ratio for Cmax (RAC Cmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B). Accumulation ratio calculated as Cmax Day 10/Cmax Day 1 (first dose) for Part B under fasted condition.

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Accumulation Ratio for Cmax (RAC Cmax) for Part B (Amorphous Suspension) Under Fasted Condition	1.368 Ratio, no units Interval 1.13 to 1.57	1.387 Ratio, no units Interval 1.02 to 1.56	1.253 Ratio, no units Interval 0.848 to 1.48	1.444 Ratio, no units Interval 1.19 to 1.92	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 10 (Part B only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess rate and extent of absorption of AZD5718 by assessment of the temporal change parameter in systemic exposure (TCP) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B).

TCP calculated as AUCτDay10/AUCDay 1 and presented values for Day 10

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Temporal Change Parameter in Systemic Exposure (TCP) for Part B (Amorphous Suspension) Under Fasted Condition	1.280 Ratio, no units Interval 1.08 to 1.45	1.349 Ratio, no units Interval 1.01 to 1.5	1.211 Ratio, no units Interval 0.822 to 1.44	1.385 Ratio, no units Interval 1.12 to 1.88	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 9 and Day 10 (Part B only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

The effect of food was evaluated by the assessment of the PK parameter (Cmax) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)	349.8 nmol/L Geometric Coefficient of Variation 34.99	1243 nmol/L Geometric Coefficient of Variation 55.23	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 9 and Day 10 (Part B only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

The effect of food was evaluated by the assessment of the PK parameter (AUC(0-t) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)	3312 h*nmol/L Geometric Coefficient of Variation 33.26	5128 h*nmol/L Geometric Coefficient of Variation 46.90	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 9 and Day 10 (Part B only)

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

The effect of food was evaluated by the assessment of the PK parameter(tmax) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)	3.51 Hours Interval 2.0 to 6.02	1.00 Hours Interval 0.98 to 1.02	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part A pre-dose and pooled intervals up to 24 hours post-dose

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess urine PK parameter (CumAe0-24) after a single administration of AZD5718 Amorphous suspension in Part A

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of Cumulative Amount of Analyte Excreted at the Last Sampling Interval (CumAe0-24) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)	206.9 nmol Standard Deviation 125.0	439.8 nmol Standard Deviation 85.95	1030 nmol Standard Deviation 449.7	5960 nmol Standard Deviation 2027	13610 nmol Standard Deviation 3850	23600 nmol Standard Deviation 8577	292.4 nmol Standard Deviation 80.50	425.9 nmol Standard Deviation 190.2	—	—

SECONDARY outcome

Timeframe: Part A pre-dose and pooled intervals up to 24 hours post-dose

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess urine PK parameter (Cumfe0-24) estimated by dividing Ae(0-last) by dose after a single administration of AZD5718 Amorphous suspension in Part A

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)	0.3695 Percentage of Dose Excreted Standard Deviation 0.2232	0.3927 Percentage of Dose Excreted Standard Deviation 0.07675	0.4598 Percentage of Dose Excreted Standard Deviation 0.2008	0.8870 Percentage of Dose Excreted Standard Deviation 0.3017	1.013 Percentage of Dose Excreted Standard Deviation 0.2865	0.8781 Percentage of Dose Excreted Standard Deviation 0.3191	0.1306 Percentage of Dose Excreted Standard Deviation 0.03594	0.06339 Percentage of Dose Excreted Standard Deviation 0.02831	—	—

SECONDARY outcome

Timeframe: Part A pre-dose and pooled intervals up to 24 hours post-dose

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the urine PK parameter (CLR) after a single administration of AZD5718 Amorphous suspension in Part A

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of Renal Clearance (CLR) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)	0.7241 Liter/hour Standard Deviation 0.2640	0.6221 Liter/hour Standard Deviation 0.09344	0.6782 Liter/hour Standard Deviation 1.599	0.6860 Liter/hour Standard Deviation 0.1634	0.7093 Liter/hour Standard Deviation 0.1118	0.6206 Liter/hour Standard Deviation 0.07438	0.4502 Liter/hour Standard Deviation 0.1043	0.4312 Liter/hour Standard Deviation 0.07115	—	—

SECONDARY outcome

Timeframe: Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the urine PK parameter (CumAe0-24) after a single administration of AZD5718 Amorphous suspension in Part B Day 9

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of Cumulative Amount of Analyte Excreted From 0 to 24 Hours (CumAe0-24) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)	953.0 nmol Standard Deviation 253.2	2219 nmol Standard Deviation 612.0	13720 nmol Standard Deviation 612.0	18920 nmol Standard Deviation 6717	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess urine PK parameter (Cumfe0-24) estimated by dividing Ae(0-last) by dose after a single administration of AZD5718 Amorphous suspension in Part B Day 9

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)	0.7092 Percentage of Dose Excreted Standard Deviation 0.1884	0.5504 Percentage of Dose Excreted Standard Deviation 0.1518	1.702 Percentage of Dose Excreted Standard Deviation 0.2911	1.408 Percentage of Dose Excreted Standard Deviation 0.4999	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose

Population: All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

To assess the urine PK parameter (CLR) after a single administration of AZD5718 Amorphous suspension in Part B Day 9

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Rate and Extent of Absorption of AZD5718 by Assessment of Renal Clearance (CLR) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)	0.6490 Liter/hour Standard Deviation 0.1029	0.7172 Liter/hour Standard Deviation 0.07593	0.9831 Liter/hour Standard Deviation 0.04645	0.7368 Liter/hour Standard Deviation 0.1654	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Admission to 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose (Part A only)

Population: All subjects who received at least 1 dose of AZD5718 or placebo and who had at least 1 pre-dose and one post-dose measurement of stimulated LTB4 and who had no major protocol deviations thought to impact on the analysis of the PD data.

To assess the change from baseline in the ex vivo stimulated LTB4 production using calcium ionophore in venous blood samples following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=12 Participants Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) n=4 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 0.5 hours post-dose	1.03 Nanogram/liter (ng/L) Interval 0.689 to 1.18	0.877 Nanogram/liter (ng/L) Interval 0.741 to 1.13	0.560 Nanogram/liter (ng/L) Interval 0.2 to 0.813	0.000219 Nanogram/liter (ng/L) Interval 0.0 to 0.00156	0.0000318 Nanogram/liter (ng/L) Interval 0.0 to 0.000208	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0127	0.877 Nanogram/liter (ng/L) Interval 0.496 to 2.6	0.781 Nanogram/liter (ng/L) Interval 0.484 to 1.04	0.852 Nanogram/liter (ng/L) Interval 0.532 to 1.23	0.934 Nanogram/liter (ng/L) Interval 0.813 to 1.46
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 1.0 hours post-dose	0.948 Nanogram/liter (ng/L) Interval 0.787 to 1.19	0.553 Nanogram/liter (ng/L) Interval 0.12 to 0.955	0.0213 Nanogram/liter (ng/L) Interval 0.000343 to 0.332	0.0000451 Nanogram/liter (ng/L) Interval 0.0 to 2.8	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0	0.930 Nanogram/liter (ng/L) Interval 0.414 to 2.52	0.497 Nanogram/liter (ng/L) Interval 0.201 to 0.833	0.646 Nanogram/liter (ng/L) Interval 0.363 to 1.02	0.833 Nanogram/liter (ng/L) Interval 0.413 to 0.87
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 2.0 hours post-dose	0.858 Nanogram/liter (ng/L) Interval 0.15 to 1.2	0.124 Nanogram/liter (ng/L) Interval 0.0144 to 0.543	0.000715 Nanogram/liter (ng/L) Interval 0.0 to 0.0358	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000155	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000197	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0000955	0.943 Nanogram/liter (ng/L) Interval 0.671 to 2.74	0.245 Nanogram/liter (ng/L) Interval 0.0193 to 0.591	0.292 Nanogram/liter (ng/L) Interval 0.0161 to 1.34	0.841 Nanogram/liter (ng/L) Interval 0.372 to 1.34
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 3.0 hours post-dose	0.672 Nanogram/liter (ng/L) Interval 0.0415 to 1.34	0.0271 Nanogram/liter (ng/L) Interval 0.00348 to 0.421	0.000165 Nanogram/liter (ng/L) Interval 0.0 to 0.00218	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000217	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0	0.965 Nanogram/liter (ng/L) Interval 0.674 to 2.96	0.0449 Nanogram/liter (ng/L) Interval 0.00161 to 0.134	0.0532 Nanogram/liter (ng/L) Interval 0.000882 to 0.799	0.647 Nanogram/liter (ng/L) Interval 0.449 to 1.36
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 4.0 hours post-dose	0.616 Nanogram/liter (ng/L) Interval 0.0234 to 0.925	0.0177 Nanogram/liter (ng/L) Interval 0.00125 to 0.0904	0.000304 Nanogram/liter (ng/L) Interval 0.0 to 0.00338	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0	0.952 Nanogram/liter (ng/L) Interval 0.772 to 2.01	0.0187 Nanogram/liter (ng/L) Interval 0.000422 to 0.0594	0.0329 Nanogram/liter (ng/L) Interval 0.0 to 0.394	0.635 Nanogram/liter (ng/L) Interval 0.0922 to 1.26
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 6.0 hours post-dose	0.443 Nanogram/liter (ng/L) Interval 0.0274 to 1.17	0.00669 Nanogram/liter (ng/L) Interval 0.00296 to 0.0307	0.000249 Nanogram/liter (ng/L) Interval 0.0 to 0.000884	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000607	0 Nanogram/liter (ng/L) Interval 0.0 to 0.00033	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000267	1.20 Nanogram/liter (ng/L) Interval 0.883 to 4.01	0.0267 Nanogram/liter (ng/L) Interval 0.00503 to 0.0888	0.00819 Nanogram/liter (ng/L) Interval 0.000518 to 0.147	0.842 Nanogram/liter (ng/L) Interval 0.337 to 1.66
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 8.0 hours post-dose	0.415 Nanogram/liter (ng/L) Interval 0.0357 to 1.08	0.0234 Nanogram/liter (ng/L) Interval 0.0089 to 0.104	0.000518 Nanogram/liter (ng/L) Interval 0.0 to 0.0114	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000708	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000646	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000148	1.41 Nanogram/liter (ng/L) Interval 1.0 to 3.63	0.0634 Nanogram/liter (ng/L) Interval 0.00861 to 0.162	0.00880 Nanogram/liter (ng/L) Interval 0.000418 to 0.212	1.39 Nanogram/liter (ng/L) Interval 0.873 to 2.01
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 12.0 hours post-dose	0.889 Nanogram/liter (ng/L) Interval 0.0612 to 1.4	0.334 Nanogram/liter (ng/L) Interval 0.0635 to 0.621	0.0515 Nanogram/liter (ng/L) Interval 0.000546 to 0.21	0.00116 Nanogram/liter (ng/L) Interval 0.0 to 0.00213	0.000106 Nanogram/liter (ng/L) Interval 0.0 to 0.000469	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000149	1.36 Nanogram/liter (ng/L) Interval 0.843 to 3.79	0.247 Nanogram/liter (ng/L) Interval 0.0854 to 0.381	0.188 Nanogram/liter (ng/L) Interval 0.00673 to 0.794	1.50 Nanogram/liter (ng/L) Interval 0.226 to 2.45
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 24.0 hours post-dose	0.874 Nanogram/liter (ng/L) Interval 0.581 to 1.55	0.470 Nanogram/liter (ng/L) Interval 0.394 to 0.716	0.435 Nanogram/liter (ng/L) Interval 0.111 to 0.702	0.0698 Nanogram/liter (ng/L) Interval 0.00817 to 0.197	0.00100 Nanogram/liter (ng/L) Interval 0.00048 to 0.0135	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000308	1.04 Nanogram/liter (ng/L) Interval 0.611 to 3.12	0.472 Nanogram/liter (ng/L) Interval 0.249 to 0.747	0.369 Nanogram/liter (ng/L) Interval 0.22 to 0.463	0.986 Nanogram/liter (ng/L) Interval 0.91 to 2.0
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 36.0 hours post-dose	1.91 Nanogram/liter (ng/L) Interval 0.676 to 3.35	1.22 Nanogram/liter (ng/L) Interval 0.62 to 2.15	0.813 Nanogram/liter (ng/L) Interval 0.592 to 1.29	0.379 Nanogram/liter (ng/L) Interval 0.205 to 1.23	0.0142 Nanogram/liter (ng/L) Interval 0.00581 to 0.0405	0.00108 Nanogram/liter (ng/L) Interval 0.00012 to 0.0643	1.70 Nanogram/liter (ng/L) Interval 1.12 to 4.28	1.04 Nanogram/liter (ng/L) Interval 0.831 to 1.47	1.04 Nanogram/liter (ng/L) Interval 0.564 to 1.49	1.31 Nanogram/liter (ng/L) Interval 1.08 to 2.4
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension 48.0 hours post-dose	1.48 Nanogram/liter (ng/L) Interval 0.947 to 2.31	1.05 Nanogram/liter (ng/L) Interval 0.808 to 1.74	0.739 Nanogram/liter (ng/L) Interval 0.531 to 0.884	0.560 Nanogram/liter (ng/L) Interval 0.411 to 1.4	0.290 Nanogram/liter (ng/L) Interval 0.079 to 0.484	0.0632 Nanogram/liter (ng/L) Interval 0.00072 to 0.211	1.23 Nanogram/liter (ng/L) Interval 0.689 to 5.46	0.638 Nanogram/liter (ng/L) Interval 0.482 to 0.918	0.940 Nanogram/liter (ng/L) Interval 0.512 to 1.29	0.893 Nanogram/liter (ng/L) Interval 0.687 to 1.68

SECONDARY outcome

Timeframe: Admission, predose and 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose

Population: All subjects who received at least 1 dose of AZD5718 or placebo and who had at least 1 pre-dose and one post-dose measurement of stimulated LTB4 and who had no major protocol deviations thought to impact on the analysis of the PD data.

To assess the change from baseline in the ex vivo stimulated LTB4 production using calcium ionophore in venous blood samples following multiple administration of AZD5718 Amorphous suspension (Part B only)

Outcome measures

Measure	Part A (Amorphous Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg \& 1200mg with 6 participants in each dose level	Part A (Crystalline Suspension) n=6 Participants Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg \& 300 mg with 6 participants in each dose level	Part B (Amorphous Suspension) n=6 Participants Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg \& 600 mg with 6 participants in each dose level	Placebo - Part A (Amorphous Suspension) n=6 Participants 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	Placebo - Part A (Crystalline Suspension) n=8 Participants 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	Placebo - Part B (Amorphous Suspension) 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	300 mg - Part A (Crystalline Suspension) Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 12, 48 hours post-dose	0.550 Nanogram/liter (ng/L) Interval 0.193 to 1.1	0.906 Nanogram/liter (ng/L) Interval 0.32 to 1.84	0.304 Nanogram/liter (ng/L) Interval 0.0743 to 0.856	0.0583 Nanogram/liter (ng/L) Interval 0.00295 to 0.813	1.05 Nanogram/liter (ng/L) Interval 0.433 to 1.47	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 1, 12 hours post-dose	0.116 Nanogram/liter (ng/L) Interval 0.00815 to 0.915	0.00171 Nanogram/liter (ng/L) Interval 0.000244 to 0.0284	0.0000984 Nanogram/liter (ng/L) Interval 0.0 to 0.000903	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000128	1.49 Nanogram/liter (ng/L) Interval 1.11 to 2.55	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 2, pre-dose	0.654 Nanogram/liter (ng/L) Interval 0.305 to 1.49	0.434 Nanogram/liter (ng/L) Interval 0.121 to 0.816	0.00350 Nanogram/liter (ng/L) Interval 0.00162 to 0.044	0.000771 Nanogram/liter (ng/L) Interval 0.0 to 0.00902	1.01 Nanogram/liter (ng/L) Interval 0.51 to 1.8	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 3, pre-dose	0.557 Nanogram/liter (ng/L) Interval 0.147 to 1.24	0.203 Nanogram/liter (ng/L) Interval 0.0116 to 0.561	0.00609 Nanogram/liter (ng/L) Interval 0.00131 to 0.0969	0.000893 Nanogram/liter (ng/L) Interval 0.0 to 0.00343	1.10 Nanogram/liter (ng/L) Interval 0.743 to 1.67	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 4, pre-dose	0.731 Nanogram/liter (ng/L) Interval 0.23 to 1.54	0.294 Nanogram/liter (ng/L) Interval 0.00887 to 1.61	0.00328 Nanogram/liter (ng/L) Interval 0.000204 to 0.0229	0.000152 Nanogram/liter (ng/L) Interval 0.0 to 0.00191	0.950 Nanogram/liter (ng/L) Interval 0.787 to 2.05	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 5, pre-dose	0.421 Nanogram/liter (ng/L) Interval 0.35 to 1.03	0.159 Nanogram/liter (ng/L) Interval 0.000491 to 0.842	0.00467 Nanogram/liter (ng/L) Interval 0.0000985 to 0.0498	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0011	0.893 Nanogram/liter (ng/L) Interval 0.591 to 1.55	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 6, pre-dose	0.472 Nanogram/liter (ng/L) Interval 0.148 to 1.29	0.227 Nanogram/liter (ng/L) Interval 0.0148 to 2.18	0.00242 Nanogram/liter (ng/L) Interval 0.000461 to 0.0226	0.000158 Nanogram/liter (ng/L) Interval 0.0 to 0.00126	0.895 Nanogram/liter (ng/L) Interval 0.488 to 1.35	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 7, pre-dose	0.511 Nanogram/liter (ng/L) Interval 0.134 to 0.907	0.376 Nanogram/liter (ng/L) Interval 0.00763 to 2.04	0.00210 Nanogram/liter (ng/L) Interval 0.000188 to 0.0527	0.000195 Nanogram/liter (ng/L) Interval 0.0 to 0.0042	1.05 Nanogram/liter (ng/L) Interval 0.791 to 1.39	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 8, pre-dose	0.583 Nanogram/liter (ng/L) Interval 0.17 to 0.962	0.134 Nanogram/liter (ng/L) Interval 0.00223 to 0.782	0.00187 Nanogram/liter (ng/L) Interval 0.000169 to 0.0255	0.000342 Nanogram/liter (ng/L) Interval 0.0 to 0.00156	0.904 Nanogram/liter (ng/L) Interval 0.625 to 1.44	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 9, pre-dose	0.288 Nanogram/liter (ng/L) Interval 0.114 to 0.408	0.0360 Nanogram/liter (ng/L) Interval 0.00731 to 0.274	0.00171 Nanogram/liter (ng/L) Interval 0.0 to 0.00622	0.000130 Nanogram/liter (ng/L) Interval 0.0 to 0.000597	0.661 Nanogram/liter (ng/L) Interval 0.518 to 1.51	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 10, pre-dose	0.164 Nanogram/liter (ng/L) Interval 0.0557 to 0.432	0.0266 Nanogram/liter (ng/L) Interval 0.00483 to 0.153	0.000908 Nanogram/liter (ng/L) Interval 0.0 to 0.00357	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000368	0.982 Nanogram/liter (ng/L) Interval 0.292 to 1.37	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 10, 2 hours post-dose	0 Nanogram/liter (ng/L) Interval 0.0 to 0.00153	0.000198 Nanogram/liter (ng/L) Interval 0.0 to 0.00109	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000371	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000123	0.812 Nanogram/liter (ng/L) Interval 0.27 to 1.36	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 10, 6 hours post-dose	0.000109 Nanogram/liter (ng/L) Interval 0.0 to 0.000387	0.0000944 Nanogram/liter (ng/L) Interval 0.0 to 0.000606	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000359	0 Nanogram/liter (ng/L) Interval 0.0 to 0.0	0.921 Nanogram/liter (ng/L) Interval 0.407 to 1.43	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 10, 12 hours post-dose	0.0143 Nanogram/liter (ng/L) Interval 0.0014 to 0.0357	0.00247 Nanogram/liter (ng/L) Interval 0.0 to 0.00772	0 Nanogram/liter (ng/L) Interval 0.0 to 0.00039	0 Nanogram/liter (ng/L) Interval 0.0 to 0.00109	1.20 Nanogram/liter (ng/L) Interval 0.289 to 2.23	—	—	—	—	—
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension Day 11, 24 hours post-dose	0.194 Nanogram/liter (ng/L) Interval 0.105 to 0.355	0.0901 Nanogram/liter (ng/L) Interval 0.00314 to 0.321	0.000426 Nanogram/liter (ng/L) Interval 0.0 to 0.0013	0 Nanogram/liter (ng/L) Interval 0.0 to 0.000279	1.20 Nanogram/liter (ng/L) Interval 0.665 to 1.46	—	—	—	—	—

Adverse Events

25 mg - Part A (Amorphous Suspension)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

50 mg - Part A (Amorphous Suspension)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

100 mg - Part A (Amorphous Suspension)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

300 mg - Part A (Amorphous Suspension)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

600 mg - Part A (Amorphous Suspension)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

1200 mg - Part A (Amorphous Suspension)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo - Part A (Amorphous Suspension)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

100 mg - Part A (Crystalline Suspension)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

300 mg - Part A (Crystalline Suspension)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo - Part A (Crystalline Suspension)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

60 mg - Part B (Amorphous Suspension)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

180 mg - Part B (Amorphous Suspension)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

360 mg - Part B (Amorphous Suspension)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

600 mg - Part B (Amorphous Suspension)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo - Part B (Amorphous Suspension)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	25 mg - Part A (Amorphous Suspension) n=6 participants at risk Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state	50 mg - Part A (Amorphous Suspension) n=6 participants at risk Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state	100 mg - Part A (Amorphous Suspension) n=6 participants at risk Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state	300 mg - Part A (Amorphous Suspension) n=6 participants at risk Participants received single dose of oral suspension of AZD5718 300 mg in amorphous state	600 mg - Part A (Amorphous Suspension) n=6 participants at risk Participants received single dose of oral suspension of AZD5718 600 mg in amorphous state	1200 mg - Part A (Amorphous Suspension) n=6 participants at risk Participants received single dose of oral suspension of AZD5718 1200 mg in amorphous state	Placebo - Part A (Amorphous Suspension) n=12 participants at risk 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension)	100 mg - Part A (Crystalline Suspension) n=6 participants at risk Participants received single dose of oral suspension of AZD5718 100 mg in crystalline state	300 mg - Part A (Crystalline Suspension) n=6 participants at risk Participants received single dose of oral suspension of AZD5718 300 mg in crystalline state. Presented only based on 5 subjects data.	Placebo - Part A (Crystalline Suspension) n=4 participants at risk 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension)	60 mg - Part B (Amorphous Suspension) n=6 participants at risk Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts	180 mg - Part B (Amorphous Suspension) n=6 participants at risk Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts	360 mg - Part B (Amorphous Suspension) n=6 participants at risk Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts	600 mg - Part B (Amorphous Suspension) n=6 participants at risk Participants received multiple doses of oral suspension of AZD5718 600 mg in amorphous state in 6 cohorts	Placebo - Part B (Amorphous Suspension) n=8 participants at risk 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension)
Nervous system disorders Headache	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	33.3% 2/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	33.3% 2/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	33.3% 2/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	12.5% 1/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Nervous system disorders Dizziness postural	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Nervous system disorders Presyncope	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Nervous system disorders Paresthesia	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	8.3% 1/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Gastrointestinal disorders Flatulence	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	12.5% 1/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Gastrointestinal disorders Bowel movement irregularity	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	12.5% 1/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Gastrointestinal disorders Nausea	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	12.5% 1/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
General disorders Medical device site reaction	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
General disorders Influenza like illness	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
General disorders Chest pain	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
General disorders Injection site bruising	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
General disorders Catheter site related reaction	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	12.5% 1/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Infections and infestations Nasopharyngitis	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	25.0% 1/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Vascular disorders Hot flush	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Cardiac disorders Palpitations	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	33.3% 2/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Eye disorders Photophobia	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Injury, poisoning and procedural complications Limb injury	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Psychiatric disorders Insomnia	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.
Nervous system disorders Dizziness	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/12 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	16.7% 1/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/4 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/6 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.	0.00% 0/8 • From screening to last follow-up visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) All randomized subjects who received at least 1 dose of IMP and for whom any safety post dose-data were available were included in the safety analysis for the study. A treatment-emergent adverse event (TEAE) was defined as an AE with onset (start date/time) after the first dose of IMP.

Additional Information

A study to assess the safety, tolerability, pharmacokinetics & dynamics of AZD5718 in healthy male

AstraZeneca AB

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.
• Publication restrictions are in place

Restriction type: OTHER