Trial Outcomes & Findings for Single + Multiple Ascending Dose and Food Effect Study of AZD7986 in Healthy Volunteers, PK, PD and Safety Study (NCT NCT02303574)

NCT ID: NCT02303574

Last Updated: 2018-12-11

Results Overview

To investigate the safety and tolerability of AZD7986 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD (Part 1a - fasted state and 1b - fed state) and MAD (Part 2)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 89 participants
• Primary outcome timeframe: Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up
• Results posted on: 2018-12-11

Participant Flow

This study was conducted at PAREXEL Early Phase Clinical Unit London, Level 7, Northwick Park Hospital in London. Healthy male and female participants were enrolled.

In Part 1 and Part 2, participants underwent a screening visit within 28 days before receiving the first dose of investigational medicinal product (IMP). Participants were admitted to the study centre 1 day before administration of the IMP (Day -1).

Participant milestones

Measure	AZD7986 5 mg (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15 mg (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 15mg on Day 1in fasted state.	AZD7986 35 mg (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50 mg (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 50mg on Day 1 in fasted state.	AZD7986 65 mg (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1 in fasted state.	AZD7986 35 mg (Fed State) - SAD Participants of Cohorts 3 from Part 1a received single dose of oral solution of AZD7986 35 mg on Day 1 in fed state after a washout of at least 7 days.	AZD7986 10 mg - MAD Participants received single dose (morning) of oral solution of AZD7986 10 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.	AZD7986 25 mg - MAD Participants received single dose (morning) of oral solution of AZD7986 25 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.	AZD7986 40 mg - MAD Participants received single dose (morning) of oral solution of AZD7986 40 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.	Placebo Randomized participants received orally AZD7986 matching placebo oral solution.
Part 1a (Fasted State)- SAD STARTED	6	6	6	6	6	0	0	0	0	15
Part 1a (Fasted State)- SAD COMPLETED	6	6	5	6	6	0	0	0	0	15
Part 1a (Fasted State)- SAD NOT COMPLETED	0	0	1	0	0	0	0	0	0	0
Part 1b (Fed State) - SAD STARTED	0	0	0	0	0	5	0	0	0	3
Part 1b (Fed State) - SAD COMPLETED	0	0	0	0	0	5	0	0	0	3
Part 1b (Fed State) - SAD NOT COMPLETED	0	0	0	0	0	0	0	0	0	0
Part 2 - Multiple Ascending Dose (MAD) STARTED	0	0	0	0	0	0	6	8	10	12
Part 2 - Multiple Ascending Dose (MAD) COMPLETED	0	0	0	0	0	0	6	7	10	12
Part 2 - Multiple Ascending Dose (MAD) NOT COMPLETED	0	0	0	0	0	0	0	1	0	0

Reasons for withdrawal

Measure	AZD7986 5 mg (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15 mg (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 15mg on Day 1in fasted state.	AZD7986 35 mg (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50 mg (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 50mg on Day 1 in fasted state.	AZD7986 65 mg (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1 in fasted state.	AZD7986 35 mg (Fed State) - SAD Participants of Cohorts 3 from Part 1a received single dose of oral solution of AZD7986 35 mg on Day 1 in fed state after a washout of at least 7 days.	AZD7986 10 mg - MAD Participants received single dose (morning) of oral solution of AZD7986 10 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.	AZD7986 25 mg - MAD Participants received single dose (morning) of oral solution of AZD7986 25 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.	AZD7986 40 mg - MAD Participants received single dose (morning) of oral solution of AZD7986 40 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.	Placebo Randomized participants received orally AZD7986 matching placebo oral solution.
Part 1a (Fasted State)- SAD Withdrawal by Subject	0	0	1	0	0	0	0	0	0	0
Part 2 - Multiple Ascending Dose (MAD) Adverse Event	0	0	0	0	0	0	0	1	0	0

Baseline Characteristics

All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.

Baseline characteristics by cohort

Measure	AZD7986 5 mg (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15 mg (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1in fasted state.	AZD7986 35 mg (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50 mg (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1 in fasted state.	AZD7986 65 mg (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1 in fasted state.	AZD7986 35 mg (Fed State) - SAD n=5 Participants Participants of Cohorts 3 from Part 1a received single dose of oral solution of AZD7986 35 mg on Day 1 in fed state after a washout of at least 7 days.	AZD7986 10 mg - MAD n=6 Participants Participants received single dose (morning) of oral solution of AZD7986 10 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.	AZD7986 25 mg - MAD n=8 Participants Participants received single dose (morning) of oral solution of AZD7986 25 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.	AZD7986 40 mg - MAD n=10 Participants Participants received single dose (morning) of oral solution of AZD7986 40 mg for 28 days (fasted or fed state, depending on Part 1b results). Participants were fasted until 1 hour after dosing when a light breakfast was provided.	Placebo - Part 1a (Fasted) n=15 Participants Randomized participants received orally AZD7986 matching placebo oral solution on Day 1 in fasted state.	Placebo - Part 1b (Fed State) n=3 Participants Randomized participants received orally AZD7986 matching placebo oral solution on Day 1 in fed state.	Placebo - Part 2 n=12 Participants Randomized participants received orally AZD7986 matching placebo oral solution for 28 days (fasted/fed state, based on part 1b results).	Total n=89 Participants Total of all reporting groups
Age, Continuous Part 1a	28.5 Years STANDARD_DEVIATION 5.39 • n=6 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	29.7 Years STANDARD_DEVIATION 8.78 • n=6 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	26.2 Years STANDARD_DEVIATION 3.66 • n=6 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	32.2 Years STANDARD_DEVIATION 10.5 • n=6 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	29.7 Years STANDARD_DEVIATION 6.65 • n=6 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	—	—	—	—	—	—	—	29.2 Years STANDARD_DEVIATION 7.14 • n=30 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.
Age, Continuous Part 1b	—	—	—	—	—	26.6 Years STANDARD_DEVIATION 3.91 • n=5 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	—	—	—	—	—	—	26.6 Years STANDARD_DEVIATION 3.91 • n=5 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.
Age, Continuous Part 2	—	—	—	—	—	—	30.7 Years STANDARD_DEVIATION 5.65 • n=6 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	38.4 Years STANDARD_DEVIATION 7.25 • n=8 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	34.4 Years STANDARD_DEVIATION 9.17 • n=10 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	—	—	—	34.8 Years STANDARD_DEVIATION 8.05 • n=24 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.
Age, Continuous Part 1a Placebo	—	—	—	—	—	—	—	—	—	29.9 Years STANDARD_DEVIATION 7.24 • n=15 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	—	—	29.9 Years STANDARD_DEVIATION 7.24 • n=15 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.
Age, Continuous Part 1b Placebo	—	—	—	—	—	—	—	—	—	—	28.7 Years STANDARD_DEVIATION 8.5 • n=3 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	—	28.7 Years STANDARD_DEVIATION 8.5 • n=3 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.
Age, Continuous Part 2 Placebo	—	—	—	—	—	—	—	—	—	—	—	36.2 Years STANDARD_DEVIATION 7.2 • n=12 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.	36.2 Years STANDARD_DEVIATION 7.2 • n=12 Participants • All randomized participants who received at least one dose of IMP were included for the presentation of all demographic data.
Sex: Female, Male Part 1a · Female	0 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=15 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=45 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.
Sex: Female, Male Part 1a · Male	6 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	6 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	6 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	6 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	6 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	15 Participants n=15 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	45 Participants n=45 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.
Sex: Female, Male Part 1b · Female	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=5 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=3 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=8 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.
Sex: Female, Male Part 1b · Male	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	5 Participants n=5 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	3 Participants n=3 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	8 Participants n=8 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.
Sex: Female, Male Part 2 · Female	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=8 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=10 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=12 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants n=36 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.
Sex: Female, Male Part 2 · Male	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	6 Participants n=6 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	8 Participants n=8 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	10 Participants n=10 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	0 Participants All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	12 Participants n=12 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.	36 Participants n=36 Participants • All randomised subjects who received at least one dose of IMP were included for the presentation of all demographic data.

PRIMARY outcome

Timeframe: Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up

Population: All randomized subjects who received at least one dose of IMP were included in the safety analysis for the study.

To investigate the safety and tolerability of AZD7986 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD (Part 1a - fasted state and 1b - fed state) and MAD (Part 2)

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=12 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=30 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=5 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=24 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=15 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=3 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Safety and Tolerability of AZD7986 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose (SAD - Part 1a and 1b) and Multiple Ascending Doses (MAD -Part 2) Any AE	8 Participants	8 Participants	2 Participants	23 Participants	8 Participants	1 Participants
Safety and Tolerability of AZD7986 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose (SAD - Part 1a and 1b) and Multiple Ascending Doses (MAD -Part 2) Any AE with outcome = death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of AZD7986 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose (SAD - Part 1a and 1b) and Multiple Ascending Doses (MAD -Part 2) Any serious adverse event (SAE) (including death)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety and Tolerability of AZD7986 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose (SAD - Part 1a and 1b) and Multiple Ascending Doses (MAD -Part 2) Any AE leading to discontinuation of AZD7986	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last)) for Part 1a (fasted state) and 1b (fed state) - SAD

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption AZD7986 by Assessment of the Area Under the Plasma Concentration Versus Time Curve, From Time Zero to the Time of the Last Quantifiable Concentration (AUC(0-last)) for Part 1a and 1b - SAD	10790 h·nmol/L Geometric Coefficient of Variation 20.2	839.0 h·nmol/L Geometric Coefficient of Variation 48.3	3855 h·nmol/L Geometric Coefficient of Variation 9.3	12430 h·nmol/L Geometric Coefficient of Variation 18.3	16470 h·nmol/L Geometric Coefficient of Variation 22.7	22880 h·nmol/L Geometric Coefficient of Variation 21.2

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last)) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of the Area Under the Plasma Concentration Versus Time Curve, From Time Zero to the Time of the Last Quantifiable Analyte Concentration (AUC(0-last)) for Part 2 - MAD	29550 h·nmol/L Geometric Coefficient of Variation 53.5	1278 h·nmol/L Geometric Coefficient of Variation 18.9 • Interval 0.5 to 1.0	3256 h·nmol/L Geometric Coefficient of Variation 15.9 • Interval 0.53 to 2.0	6427 h·nmol/L Geometric Coefficient of Variation 31.0 • Interval 0.53 to 1.5	5135 h·nmol/L Geometric Coefficient of Variation 49.4	14320 h·nmol/L Geometric Coefficient of Variation 39.5

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the area under plasma concentration-time curve from zero extrapolated to infinity (AUC) for Part 1a (fasted state) and 1b (fed state) - SAD. AUC was estimated by AUC(0 last) + Clast/λz where Clast was the last observed quantifiable concentration.

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) for Part 1a and 1b - SAD	11550 h·nmol/L Geometric Coefficient of Variation 22.6	915.3 h·nmol/L Geometric Coefficient of Variation 46.1	4165 h·nmol/L Geometric Coefficient of Variation 10.8	13230 h·nmol/L Geometric Coefficient of Variation 19.6	17590 h·nmol/L Geometric Coefficient of Variation 25.2	24710 h·nmol/L Geometric Coefficient of Variation 21.5

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the area under plasma concentration-time curve from zero extrapolated to infinity (AUC) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2. Note: Day 1 data calculated over a 24 hour period and was therefore not comparable with the Day 21 and Day 28 data

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) for Part 2 - MAD	33220 h·nmol/L Geometric Coefficient of Variation 58.5	1778 h·nmol/L Geometric Coefficient of Variation 21.3 • Interval 0.5 to 1.0	4957 h·nmol/L Geometric Coefficient of Variation 19.5 • Interval 0.53 to 2.0	9866 h·nmol/L Geometric Coefficient of Variation 35.8 • Interval 0.53 to 1.5	5565 h·nmol/L Geometric Coefficient of Variation 54.3	16660 h·nmol/L Geometric Coefficient of Variation 44.2

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess area under the plasma concentration-time curve from time zero to the end of the dosing interval (AUCτ) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2. AUCτ: AUC from time zero to 24 hours post-dose presented on Day1

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCτ) for Part 2 - MAD	15660 h·nmol/L Geometric Coefficient of Variation 43.3	1277 h·nmol/L Geometric Coefficient of Variation 18.9 • Interval 0.5 to 1.0	3259 h·nmol/L Geometric Coefficient of Variation 15.9 • Interval 0.53 to 2.0	6433 h·nmol/L Geometric Coefficient of Variation 31.0 • Interval 0.53 to 1.5	2834 h·nmol/L Geometric Coefficient of Variation 35.1	7499 h·nmol/L Geometric Coefficient of Variation 27.4

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the observed maximum plasma concentration (Cmax) for Part 1a (fasted state) and 1b (fed state) - SAD. Cmax was taken directly from the individual concentration-time curve

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption AZD7986 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part 1a and 1b - SAD	434.8 nmol/L Geometric Coefficient of Variation 14.0	50.74 nmol/L Geometric Coefficient of Variation 47.2	202.3 nmol/L Geometric Coefficient of Variation 16.0	668.1 nmol/L Geometric Coefficient of Variation 26.7	1035 nmol/L Geometric Coefficient of Variation 11.5	1358 nmol/L Geometric Coefficient of Variation 24.2

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assessthe observed maximum plasma concentration (Cmax) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2. Cmax was taken directly from the individual concentration-time curve

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part 2 - MAD	1235 nmol/L Geometric Coefficient of Variation 37.7	138.6 nmol/L Geometric Coefficient of Variation 18.3 • Interval 0.5 to 1.0	350.9 nmol/L Geometric Coefficient of Variation 19.3 • Interval 0.53 to 2.0	672.0 nmol/L Geometric Coefficient of Variation 37.0 • Interval 0.53 to 1.5	246.3 nmol/L Geometric Coefficient of Variation 26.2	598.1 nmol/L Geometric Coefficient of Variation 15.5

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the time to reach maximum observed concentration (tmax) for Part 1a (fasted state) and 1b (fed state) - SAD; tmax was taken directly from the individual concentration-time curve

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption AZD7986 by Assessment of the Time to Reach Maximum Observed Concentration (Tmax) for Part 1a and 1b - SAD	4.00 Hour Full Range 14.0 • Interval 3.0 to 4.98	0.50 Hour Full Range 47.2 • Interval 0.5 to 1.0	0.75 Hour Full Range 16.0 • Interval 0.53 to 2.0	0.75 Hour Full Range 26.7 • Interval 0.53 to 1.5	0.64 Hour Full Range 11.5 • Interval 0.52 to 0.75	0.75 Hour Full Range 24.2 • Interval 0.52 to 1.98

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the time to reach maximum observed concentration (tmax) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; tmax was taken directly from the individual concentration-time curve

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of the Time to Reach Maximum Observed Concentration (Tmax) for Part 2 - MAD	1.12 Hour Interval 0.53 to 1.5	1.51 Hour Full Range 21.3 • Interval 0.52 to 1.53	0.75 Hour Full Range 19.5 • Interval 0.53 to 2.0	0.75 Hour Full Range 35.8 • Interval 0.52 to 1.5	1.50 Hour Interval 0.75 to 1.5	0.75 Hour Interval 0.52 to 2.0

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the half life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½.λz) for Part 1a (fasted state) and 1b (fed state) - SAD

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption AZD7986 by Assessment of the Apparent Terminal Elimination Half-life (t½.λz) for Part 1a and 1b - SAD	24.24 Hour Standard Deviation 4.259 • Interval 3.0 to 4.98	19.96 Hour Standard Deviation 3.416 • Interval 0.5 to 1.0	25.92 Hour Standard Deviation 4.452 • Interval 0.53 to 2.0	23.80 Hour Standard Deviation 3.328 • Interval 0.53 to 1.5	24.52 Hour Standard Deviation 5.836 • Interval 0.52 to 0.75	25.50 Hour Standard Deviation 7.254 • Interval 0.52 to 1.98

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the apparent terminal elimination half-life (t½.λz) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; tmax was taken directly from the individual concentration-time curve. Note: Day 1 data were calculated over a 24 hour period and was therefore not comparable with the Day 21 and Day 28 data

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of the Apparent Terminal Elimination Half-life (t½.λz) for Part 2 - MAD	30.04 Hour Standard Deviation 5.483	12.82 Hour Standard Deviation 1.477 • Interval 0.52 to 1.53	14.85 Hour Standard Deviation 2.244 • Interval 0.53 to 2.0	15.85 Hour Standard Deviation 4.132 • Interval 0.52 to 1.5	25.85 Hour Standard Deviation 5.501	33.78 Hour Standard Deviation 10.31

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the mean residence time (MRT) for Part 1a (fasted state) and 1b (fed state) - SAD

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption AZD7986 by Assessment of the Mean Residence Time (MRT) for Part 1a and 1b - SAD	33.73 Hour Standard Deviation 6.429 • Interval 3.0 to 4.98	27.03 Hour Standard Deviation 4.373 • Interval 0.5 to 1.0	34.94 Hour Standard Deviation 5.863 • Interval 0.53 to 2.0	32.15 Hour Standard Deviation 5.003 • Interval 0.53 to 1.5	32.19 Hour Standard Deviation 8.360 • Interval 0.52 to 0.75	33.76 Hour Standard Deviation 10.35 • Interval 0.52 to 1.98

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the mean residence time (MRT) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Mean Residence Time (MRT) for Part 2 - MAD	37.46 Hour Standard Deviation 8.157	18.56 Hour Standard Deviation 2.245 • Interval 0.52 to 1.53	21.84 Hour Standard Deviation 3.067 • Interval 0.53 to 2.0	22.64 Hour Standard Deviation 5.844 • Interval 0.52 to 1.5	33.73 Hour Standard Deviation 9.663	40.16 Hour Standard Deviation 10.58

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the apparent clearance (CL/F) for Part 1a (fasted state) and 1b (fed state) - SAD; CL/F for parent drug was estimated as dose divided by AUC

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption AZD7986 by Assessment of the Apparent Clearance (CL/F) for Part 1a and 1b - SAD	7.363 Litre/Hour Standard Deviation 1.810 • Interval 3.0 to 4.98	14.23 Litre/Hour Standard Deviation 7.577 • Interval 0.5 to 1.0	8.606 Litre/Hour Standard Deviation 0.9321 • Interval 0.53 to 2.0	6.395 Litre/Hour Standard Deviation 1.281 • Interval 0.53 to 1.5	6.938 Litre/Hour Standard Deviation 1.777 • Interval 0.52 to 0.75	6.371 Litre/Hour Standard Deviation 1.317 • Interval 0.52 to 1.98

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the apparent clearance (CL/F) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; CL/F for parent drug was estimated as dose divided by AUC

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of the Apparent Clearance (CL/F) for Part 2 - MAD	6.577 Litre/Hour Standard Deviation 2.867	13.61 Litre/Hour Standard Deviation 2.665 • Interval 0.52 to 1.53	12.20 Litre/Hour Standard Deviation 2.485 • Interval 0.53 to 2.0	10.24 Litre/Hour Standard Deviation 4.206 • Interval 0.52 to 1.5	8.786 Litre/Hour Standard Deviation 2.772	8.165 Litre/Hour Standard Deviation 2.025

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the apparent volume of distribution (Vz/F) for Part 1a (fasted state) and 1b (fed state) - SAD; Vz/F at terminal phase (extravascular administration) was estimated by dividing the apparent clearance (CL/F) by λz

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption AZD7986 by Assessment of the Apparent Volume of Distribution (Vz/F) for Part 1a and 1b - SAD	249.5 Litre Standard Deviation 24.96 • Interval 3.0 to 4.98	385.1 Litre Standard Deviation 129.6 • Interval 0.5 to 1.0	318.8 Litre Standard Deviation 46.72 • Interval 0.53 to 2.0	215.8 Litre Standard Deviation 29.62 • Interval 0.53 to 1.5	236.8 Litre Standard Deviation 39.64 • Interval 0.52 to 0.75	231.0 Litre Standard Deviation 67.56 • Interval 0.52 to 1.98

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the the apparent volume of distribution (Vz/F) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; Vz/F at terminal phase (extravascular administration) was estimated by dividing the apparent clearance (CL/F) by λz

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of the Apparent Volume of Distribution (Vz/F) for Part 2 - MAD	269.6 Litre Standard Deviation 79.13	248.9 Litre Standard Deviation 38.94 • Interval 0.52 to 1.53	256.7 Litre Standard Deviation 36.11 • Interval 0.53 to 2.0	222.7 Litre Standard Deviation 65.93 • Interval 0.52 to 1.5	311.8 Litre Standard Deviation 56.96	393.2 Litre Standard Deviation 163.1

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the accumulation ratio for (Rac(AUC(0-τ)) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; estimated as AUC(0-τ) Day 21/AUC(0-24) Day 1

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of the Accumulation Ratio for (Rac(AUC(0-τ)) for Part 2 - MAD	2.476 Ratio Standard Deviation 0.4521	NA Ratio Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA Ratio Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA Ratio Standard Deviation NA NA - Not applicable. Not assessed for Day 1	2.257 Ratio Standard Deviation 0.4560	2.330 Ratio Standard Deviation 0.4828

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the accumulation ratio for Cmax (Rac(Cmax)) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; estimated as Cmax Day 21/Cmax Day 1

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of the Accumulation Ratio for Cmax (Rac(Cmax)) for Part 2 - MAD	1.881 Ratio Standard Deviation 0.4015	NA Ratio Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA Ratio Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA Ratio Standard Deviation NA NA - Not applicable. Not assessed for Day 1	1.799 Ratio Standard Deviation 0.3084	1.667 Ratio Standard Deviation 0.2007

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the temporal change parameter (TCP) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; estimated as AUC(0-τ) Day 21/AUC Day 1, if extrapolated part was less than 20%

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of the Temporal Change Parameter (TCP) for Part 2 - MAD	1.599 Ratio Standard Deviation 0.2082	NA Ratio Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA Ratio Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA Ratio Standard Deviation NA NA - Not applicable. Not assessed for Day 1	1.610 Ratio Standard Deviation 0.2539	1.535 Ratio Standard Deviation 0.2479

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess cumulative amount of analyte excreted from 0 to 48 hours (CumAe0-48) after single dose administration of AZD7986 oral solution in Part 1a (fasted state) and 1b (fed state)

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK Parameter (Cumulative Amount of Analyte Excreted From 0 to 48 Hours (CumAe0-48)) Following Administration of Single Dose Oral Solution for Part 1a and 1b - SAD	18420 nmol Standard Deviation 2554 • Interval 3.0 to 4.98	1318 nmol Standard Deviation 348.5 • Interval 0.5 to 1.0	4820 nmol Standard Deviation 1096 • Interval 0.53 to 2.0	16530 nmol Standard Deviation 2145 • Interval 0.53 to 1.5	19660 nmol Standard Deviation 4521 • Interval 0.52 to 0.75	27770 nmol Standard Deviation 10200 • Interval 0.52 to 1.98

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess percentage of dose excreted unchanged into the urine from 0 to 48 hours (Cumfe0-48) after single dose administration of AZD7986 oral solution in Part 1a (fasted state) and 1b (fed state)

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK Parameter (Percentage of Dose Excreted Unchanged Into the Urine From 0 to 48 Hours (Cumfe0-48)) Following Administration of Single Dose Oral Solution for Part 1a and 1b - SAD	22.13 Percentage of dose excreted unchanged Standard Deviation 3.069	11.09 Percentage of dose excreted unchanged Standard Deviation 2.931	13.51 Percentage of dose excreted unchanged Standard Deviation 3.074	19.86 Percentage of dose excreted unchanged Standard Deviation 2.578	16.53 Percentage of dose excreted unchanged Standard Deviation 3.802	17.97 Percentage of dose excreted unchanged Standard Deviation 6.598

PRIMARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess renal clearance from 0 to 48 hours (CLR0-48) after single dose administration of AZD7986 oral solution in Part 1a (fasted state) and 1b (fed state)

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=5 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK Parameter (Renal Clearance From 0 to 48 Hours (CLR0-48)) Following Administration of Single Dose Oral Solution for Part 1a and 1b - SAD	2.097 Liter/hour Standard Deviation 0.1921	1.734 Liter/hour Standard Deviation 0.368	1.544 Liter/hour Standard Deviation 0.2898	1.619 Liter/hour Standard Deviation 0.2101	1.430 Liter/hour Standard Deviation 0.1561	1.477 Liter/hour Standard Deviation 0.5187

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess cumulative amount of analyte excreted from 0 to 24 hours (CumAe0-24) for Part 2

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Cumulative Amount of Analyte Excreted From 0 to 24 Hours (CumAe0-24)) Parameters for Part 2 - MAD	24970 nmol Standard Deviation 8075	2295 nmol Standard Deviation 638.1 • Interval 0.52 to 1.53	5540 nmol Standard Deviation 1305 • Interval 0.53 to 2.0	11390 nmol Standard Deviation 2415 • Interval 0.52 to 1.5	4002 nmol Standard Deviation 1402	11960 nmol Standard Deviation 4665

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess percentage of dose excreted unchanged into the urine from 0 to 24 hours (Cumfe0 24) for Part 2

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24)) Parameter for Part 2 - MAD	26.25 Percentage of dose excreted unchanged Standard Deviation 8.489	9.650 Percentage of dose excreted unchanged Standard Deviation 2.683 • Interval 0.75 to 1.5	9.319 Percentage of dose excreted unchanged Standard Deviation 2.195	11.98 Percentage of dose excreted unchanged Standard Deviation 2.539	16.83 Percentage of dose excreted unchanged Standard Deviation 5.894	20.12 Percentage of dose excreted unchanged Standard Deviation 7.847

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess renal clearance from 0 to 24 hours (CLR0-24) for Part 2

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Renal Clearance From 0 to 24 Hours (CLR0-24)) Parameter for Part 2 - MAD	NA Liter/hour Standard Deviation NA NA - Not applicable	1.784 Liter/hour Standard Deviation 0.4606 • Interval 0.75 to 1.5	1.685 Liter/hour Standard Deviation 0.3441	1.782 Liter/hour Standard Deviation 0.3841	NA Liter/hour Standard Deviation NA NA - Not applicable	NA Liter/hour Standard Deviation NA NA - Not applicable

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess Cumulative amount of analyte excreted from 0 to 48 hours (CumAe0-48)) for Part 2

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Cumulative Amount of Analyte Excreted From 0 to 48 Hours (CumAe0-48)) Parameter for Part 2 - MAD	36160 nmol Standard Deviation 12030	NA nmol Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA nmol Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA nmol Standard Deviation NA NA - Not applicable. Not assessed for Day 1	6525 nmol Standard Deviation 2684	18680 nmol Standard Deviation 8765

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess Percentage of dose excreted unchanged into the urine from 0 to 48 hours (Cumfe0 48) for Part 2

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Percentage of Dose Excreted Unchanged Into the Urine From 0 to 48 Hours (Cumfe0 48)) Parameter for Part 2 - MAD	38.01 Percentage of dose excreted unchanged Standard Deviation 12.65	NA Percentage of dose excreted unchanged Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA Percentage of dose excreted unchanged Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA Percentage of dose excreted unchanged Standard Deviation NA NA - Not applicable. Not assessed for Day 1	27.44 Percentage of dose excreted unchanged Standard Deviation 11.29	31.42 Percentage of dose excreted unchanged Standard Deviation 14.74

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess Percentage of dose excreted unchanged into the urine from 0 to 48 hours (Cumfe0 48) for Part 2

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD n=10 Participants Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD n=7 Participants Participants received single dose of oral solution of AZD7986 65mg on Day 1
Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Renal Clearance From 0 to 48 Hours (CLR0-48)) Parameter for Part 2 - MAD	1.527 Liter/hour Standard Deviation 0.3418	NA Liter/hour Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA Liter/hour Standard Deviation NA NA - Not applicable. Not assessed for Day 1	NA Liter/hour Standard Deviation NA NA - Not applicable. Not assessed for Day 1	1.508 Liter/hour Standard Deviation 0.438	1.618 Liter/hour Standard Deviation 0.5085

SECONDARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the effect of food by evaluating the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last)) for Part 1a (fasted state) and 1b (fed state) - SAD

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=5 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1
Effect of Food on Absorption AZD7986 by Assessment of the Area Under the Plasma Concentration Versus Time Curve, From Time Zero to the Time of the Last Quantifiable Concentration (AUC(0-last)) for Part 1a and 1b - SAD	—	12430 h·nmol/L Geometric Coefficient of Variation 18.3	10790 h·nmol/L Geometric Coefficient of Variation 20.2	—	—	—

SECONDARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the effect of food by evaluating the area under plasma concentration-time curve from zero extrapolated to infinity (AUC) for Part 1a (fasted state) and 1b (fed state) - SAD. AUC was estimated by AUC(0 last) + Clast/λz where Clast was the last observed quantifiable concentration.

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=5 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1
Effect of Food on Absorption AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) for Part 1a and 1b - SAD	—	13230 h·nmol/L Geometric Coefficient of Variation 19.6	11550 h·nmol/L Geometric Coefficient of Variation 22.6	—	—	—

SECONDARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the effect of food by evaluating the observed maximum plasma concentration (Cmax) for Part 1a (fasted state) and 1b (fed state) - SAD. Cmax was taken directly from the individual concentration-time curve

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=5 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1
Effect of Food on Absorption AZD7986 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part 1a and 1b - SAD	—	668.1 nmol/L Geometric Coefficient of Variation 26.7	434.8 nmol/L Geometric Coefficient of Variation 14.0	—	—	—

SECONDARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the effect of food by evaluating the time to reach maximum observed concentration (tmax) for Part 1a (fasted state) and 1b (fed state) - SAD; tmax was taken directly from the individual concentration-time curve

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=5 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1
Effect of Food on Absorption AZD7986 by Assessment of the Time to Reach Maximum Observed Concentration (Tmax) for Part 1a and 1b - SAD	—	0.75 Hour Full Range 26.7 • Interval 0.53 to 1.5	4.00 Hour Full Range 14.0 • Interval 3.0 to 4.98	—	—	—

SECONDARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the effect of food by evaluating the half life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½.λz) for Part 1a (fasted state) and 1b (fed state) - SAD

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=5 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1
Effect of Food on Absorption AZD7986 by Assessment of the Apparent Terminal Elimination Half-life (t½.λz) for Part 1a and 1b - SAD	—	23.80 Hour Standard Deviation 3.328 • Interval 0.53 to 1.5	24.24 Hour Standard Deviation 4.259 • Interval 3.0 to 4.98	—	—	—

SECONDARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the effect of food by evaluating the mean residence time (MRT) for Part 1a (fasted state) and 1b (fed state) - SAD

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=5 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1
Effect of Food on Absorption AZD7986 by Assessment of the Mean Residence Time (MRT) for Part 1a and 1b - SAD	—	32.15 Hour Standard Deviation 5.003 • Interval 0.53 to 1.5	33.73 Hour Standard Deviation 6.429 • Interval 3.0 to 4.98	—	—	—

SECONDARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the effect of food by evaluating the apparent clearance (CL/F) for Part 1a (fasted state) and 1b (fed state) - SAD; CL/F for parent drug was estimated as dose divided by AUC

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=5 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1
Effect of Food on Absorption AZD7986 by Assessment of the Apparent Clearance (CL/F) for Part 1a and 1b - SAD	—	6.395 Litre/Hour Standard Deviation 1.281 • Interval 0.53 to 1.5	7.363 Litre/Hour Standard Deviation 1.810 • Interval 3.0 to 4.98	—	—	—

SECONDARY outcome

Timeframe: At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)

Population: The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.

To assess the effect of food by evaluating the apparent volume of distribution (Vz/F) for Part 1a (fasted state) and 1b (fed state) - SAD; Vz/F at terminal phase (extravascular administration) was estimated by dividing the apparent clearance (CL/F) by λz

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=5 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1
Effect of Food on Absorption AZD7986 by Assessment of the Apparent Volume of Distribution (Vz/F) for Part 1a and 1b - SAD	—	215.8 Litre Standard Deviation 29.62	249.5 Litre Standard Deviation 24.96	—	—	—

SECONDARY outcome

Timeframe: At Day 16, 21 ((last dosing day in Cohort 1), 25, 28 (last sampling day in Cohort 1 and last dosing day in Cohorts 2 and 3), 32, 38, 41 and 52

Population: All participants who receiving at least 1 dose of AZD7986 or placebo and who had at least 1 pre-dose and 1 post-dose measurement for either NE (NE1 or NE2), and who had no major protocol deviations thought to impact on the analysis of the PD data

Absolute neutrophil count (ANC) was evaluated as part of the safety laboratory assessments and to evaluate the pharmacodynamics (PD) marker

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=12 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1
Assessment of Mean Normalized Relative Neutrophil Elastase (NE) Activity in All Cohorts of Part 2 Day 16	—	-7.53 Percentage change in NE activity Standard Deviation 11.59	-28.25 Percentage change in NE activity Standard Deviation 22.33	-28.10 Percentage change in NE activity Standard Deviation 16.87	7.39 Percentage change in NE activity Standard Deviation 13.06	—
Assessment of Mean Normalized Relative Neutrophil Elastase (NE) Activity in All Cohorts of Part 2 Day 21	—	-26.13 Percentage change in NE activity Standard Deviation 3.116	-36.73 Percentage change in NE activity Standard Deviation 11.76	-52.31 Percentage change in NE activity Standard Deviation 14.90	1.39 Percentage change in NE activity Standard Deviation 20.14	—
Assessment of Mean Normalized Relative Neutrophil Elastase (NE) Activity in All Cohorts of Part 2 Day 25	—	-30.15 Percentage change in NE activity Standard Deviation 8.412	-40.06 Percentage change in NE activity Standard Deviation 6.609	-59.02 Percentage change in NE activity Standard Deviation 11.77	-5.15 Percentage change in NE activity Standard Deviation 14.14	—
Assessment of Mean Normalized Relative Neutrophil Elastase (NE) Activity in All Cohorts of Part 2 Day 28	—	-39.22 Percentage change in NE activity Standard Deviation 9.141	-45.05 Percentage change in NE activity Standard Deviation 8.304	-55.24 Percentage change in NE activity Standard Deviation 9.087	-16.36 Percentage change in NE activity Standard Deviation 22.03	—
Assessment of Mean Normalized Relative Neutrophil Elastase (NE) Activity in All Cohorts of Part 2 Day 32	—	NA Percentage change in NE activity Standard Deviation NA NA: not applicable.	-53.35 Percentage change in NE activity Standard Deviation 8.292	-46.29 Percentage change in NE activity Standard Deviation 37.55	-6.216 Percentage change in NE activity Standard Deviation 14.28	—
Assessment of Mean Normalized Relative Neutrophil Elastase (NE) Activity in All Cohorts of Part 2 Day 38	—	NA Percentage change in NE activity Standard Deviation NA NA: not applicable.	-54.42 Percentage change in NE activity Standard Deviation 6.800	-65.44 Percentage change in NE activity Standard Deviation 7.556	-19.51 Percentage change in NE activity Standard Deviation 10.74	—
Assessment of Mean Normalized Relative Neutrophil Elastase (NE) Activity in All Cohorts of Part 2 Day 41	—	NA Percentage change in NE activity Standard Deviation NA NA: not applicable.	-53.46 Percentage change in NE activity Standard Deviation 9.774	-62.56 Percentage change in NE activity Standard Deviation 8.324	-18.14 Percentage change in NE activity Standard Deviation 15.62	—
Assessment of Mean Normalized Relative Neutrophil Elastase (NE) Activity in All Cohorts of Part 2 Day 52	—	NA Percentage change in NE activity Standard Deviation NA NA: not applicable.	-17.73 Percentage change in NE activity Standard Deviation 18.07	-21.31 Percentage change in NE activity Standard Deviation 18.07	-20.98 Percentage change in NE activity Standard Deviation 15.32	—

SECONDARY outcome

Timeframe: At Day 12 (pre-dose, 6 hours and 12 hours)

Population: All participants who receiving at least 1 dose of AZD7986 or placebo and who had at least 1 pre-dose and 1 post-dose measurement for either NE (NE1 or NE2), and who had no major protocol deviations thought to impact on the analysis of the PD data

Absolute neutrophil count (ANC) was evaluated as part of the safety laboratory assessments and to evaluate the pharmacodynamics (PD) marker

Outcome measures

Measure	AZD7986 40mg - Day 28 - Part 2 - MAD Participants received single dose of oral solution of AZD7986 40mg on Day 1 and daily dosing on Days 21 or 28 I fasted state.	AZD7986 5mg - Part 1a (Fasted State) - SAD n=6 Participants Participants received single dose of oral solution of AZD7986 5mg on Day 1 in fasted state.	AZD7986 15mg - Part 1a (Fasted State) - SAD n=8 Participants Participants received single dose of oral solution of AZD7986 15mg on Day 1.	AZD7986 35mg - Part 1a (Fasted State) - SAD n=10 Participants Participants received single dose of oral solution of AZD7986 35mg on Day 1 in fasted state.	AZD7986 50mg - Part 1a (Fasted State) - SAD n=12 Participants Participants received single dose of oral solution of AZD7986 50mg on Day 1	AZD7986 65mg - Part 1a (Fasted State) - SAD Participants received single dose of oral solution of AZD7986 65mg on Day 1
Assessment of Absolute Neutrophil Count (ANC) in All Cohorts of Part 2 Day 12, Pre-dose	—	2.757 10^9 neutrophils/L Standard Deviation 0.4178	2.881 10^9 neutrophils/L Standard Deviation 0.5222	2.560 10^9 neutrophils/L Standard Deviation 0.9108	2.945 10^9 neutrophils/L Standard Deviation 0.7966	—
Assessment of Absolute Neutrophil Count (ANC) in All Cohorts of Part 2 Day 12, 6 h	—	NA 10^9 neutrophils/L Standard Deviation NA NA: not applicable. Not assessed for AZD7986 10 mg.	3.401 10^9 neutrophils/L Standard Deviation 1.049	3.129 10^9 neutrophils/L Standard Deviation 0.7210	3.402 10^9 neutrophils/L Standard Deviation 1.178	—
Assessment of Absolute Neutrophil Count (ANC) in All Cohorts of Part 2 Day 12, 12 h	—	NA 10^9 neutrophils/L Standard Deviation NA NA: not applicable. Not assessed for AZD7986 10 mg.	3.454 10^9 neutrophils/L Standard Deviation 0.7448	3.460 10^9 neutrophils/L Standard Deviation 0.5248	3.247 10^9 neutrophils/L Standard Deviation 0.7622	—

Adverse Events

Part 1a (Fasted State) - Single Ascending Dose (SAD)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 1b (Fed State) - SAD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2 - Multiple Ascending Dose (MAD)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo - Part 1a (Fasted State)- SAD

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo - Part 1b (Fed State) - SAD

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo - Part 2 - MAD

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1a (Fasted State) - Single Ascending Dose (SAD) n=30 participants at risk Participants received single dose of oral solution of AZD7986 at 5 ascending doses (5mg, 15mg, 35mg, 50mg and 65mg) on Day 1 in fasted state with 6 participants in each dose level.	Part 1b (Fed State) - SAD n=5 participants at risk 5 Participants of Cohort 3 from Part 1a received single dose of oral solution of AZD7986 35mg on Day 1 in fed state after a washout of at least 7 days.	Part 2 - Multiple Ascending Dose (MAD) n=24 participants at risk 24 participants (6 in Cohort 1-10mg, 8 in Cohort 2- 25mg and 10 in Cohort 3-40mg) received once daily dose of oral solution of AZD7986 in the morning for 28 days. Participants were fasted until 1 hour after dosing when a light breakfast was provided.	Placebo - Part 1a (Fasted State)- SAD n=15 participants at risk 3 participants per dose level received single dose of oral solution of placebo in Part 1a in fasted state on Day 1	Placebo - Part 1b (Fed State) - SAD n=3 participants at risk 3 participants of Cohort 3 from Part 1a received single dose of oral solution of placebo 35mg on Day 1 in fed state after a washout of at least 7 days.	Placebo - Part 2 - MAD n=12 participants at risk 12 participants (randomized 6:3, 8:3 and 10:4/10:6/12:4) received once daily dose of oral solution of Placebo in the morning for 28 days. Participants were fasted until 1 hour after dosing when a light breakfast was provided.
Gastrointestinal disorders Abdominal pain	3.3% 1/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Dry mouth	3.3% 1/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Dyspepsia	3.3% 1/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Rectal haemorrhage	3.3% 1/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Gingival bleeding	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	20.0% 1/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	12.5% 3/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	33.3% 1/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	16.7% 2/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Constipation	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	16.7% 4/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	16.7% 2/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 2/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Lip dry	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 2/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Nausea	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 2/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Diarrhoea	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Flatulence	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Gingival pain	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Vomiting	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Nervous system disorders Headache	10.0% 3/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	40.0% 2/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	25.0% 6/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	13.3% 2/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Nervous system disorders Dizziness	3.3% 1/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 2/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	16.7% 2/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Nervous system disorders Paraesthesia	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Nervous system disorders Dizziness postural	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
General disorders Fatigue	3.3% 1/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 2/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
General disorders Pain	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 2/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
General disorders Axillary pain	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
General disorders Catheter site related reaction	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
General disorders Chest discomfort	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
General disorders Asthenia	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
General disorders Feeling hot	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	16.7% 2/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
General disorders Vessel puncture site pain	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Infections and infestations Nasopharyngitis	3.3% 1/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	12.5% 3/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.3% 1/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	12.5% 3/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	16.7% 2/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	20.0% 1/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	20.0% 1/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	16.7% 2/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 2/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Psychiatric disorders Insomnia	3.3% 1/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Skin irritation	3.3% 1/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	20.0% 1/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 2/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	12.5% 3/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Skin hypertrophy	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Cardiac disorders Palpitations	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Cardiac disorders Sinus tachycardia	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Vascular disorders Hot flush	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Vascular disorders Systolic hypertension	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	6.7% 1/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Investigations Weight decreased	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	8.3% 1/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Immune system disorders Seasonal allergy	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Ear and labyrinth disorders Excessive cerumen production	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Injury, poisoning and procedural complications Laceration	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
General disorders Arthropod bite	0.00% 0/30 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/5 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	4.2% 1/24 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/15 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/3 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.	0.00% 0/12 • Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up All randomized participants who received at least 1 dose of IMP were included in the safety analysis. Adverse events (AEs - serious / non-serious), an undesirable medical condition occurring at any time after the participant had signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.

Additional Information

Bengt Larsson

AstraZeneca

Phone: +46 766 346712

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