Trial Outcomes & Findings for First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects (NCT NCT05427253)

Last Updated: 2025-01-31

Results Overview

AE reporting and questioning. AEs must be recorded in the AE Log of the eCRF. The Investigator must provide information on the AE, preferably with a diagnosis or at least with signs and symptoms; start and stop dates, start and stop time; intensity; causal relationship to IMP; action taken, and outcome. If the AE is serious, this must be indicated in the eCRF. AEs, including out-of-range clinically significant clinical safety laboratory values, must be recorded individually, except when considered manifestations of the same medical condition or disease state; in such cases, they must be recorded under a single diagnosis. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

80 participants

Primary outcome timeframe

From date of signing informed consent until End of Study, assessed up to Day 22

Results posted on

2025-01-31

Participant Flow

The subjects were recruited from CTC's database of healthy volunteers and patients, as well as from strategic marketing campaigns. Advertisements in social media and other media. Single ascending dose (SAD) part: First subject screened: 08-Jun-2022 Last subject completed: 09-May-2023 Multiple ascending dose (MAD) part: First subject screened: 19-Aug-2022 Last subject completed: 22-Jun-2023

SAD part: Screened - 92 subjects, included - 48 subjects. Subjects in the SAD Part Cohort 4, dose 180 mg group were supposed to completed additional trial visits exploring single dose administration of C106 under fed conditions, this group is called SAD Part Cohort 4, dose 180 mg fasted first, then Dose 180 mg Fed. MAD part: Screened - 77 subjects, included 32 subjects. 28 subjects completed all 3 trial visits (multiple dose administration of C106). 4 subjects were withdrawn from the trial.

Participant milestones

Participant milestones
Measure	SAD Part Cohort 1, Dose 5 mg Oral administration, Single dose 5 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 2, Dose 30 mg Oral administration, Single dose 30 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 3, Dose 60 mg Oral administration, Single dose 60 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg Fasted First, Then Dose 180 mg Fed Oral administration, Single dose 180 mg oral solution Subjects proceed from the SAD Part Cohort 4, dose 180 mg fasting after a washout period of at least 5 half-lives of C106 to a second period where the intervention of 180 mg is given under fed condition. C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 5, Dose 240 mg Oral administration, Single dose 240 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Cohort 6, Dose 300 mg Oral administration, Single dose 300 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Placebo Oral administration, Single dose placebo oral solution	MAD Part, Dose 40mg Oral administration dose 40 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 100mg Oral administration dose 100 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 140mg Oral administration dose 140 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 180mg Oral administration dose 180 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Placebo Oral administration of placebo oral solution twice daily for 8 days
Intervention Under Fasting Condition STARTED	6	6	6	6	6	6	12	6	6	6	6	8
Intervention Under Fasting Condition COMPLETED	6	6	6	6	6	6	12	6	4	6	4	8
Intervention Under Fasting Condition NOT COMPLETED	0	0	0	0	0	0	0	0	2	0	2	0
Wash Out for SAD Part Cohort 4, Dose 180 STARTED	0	0	0	6	0	0	0	0	0	0	0	0
Wash Out for SAD Part Cohort 4, Dose 180 COMPLETED	0	0	0	6	0	0	0	0	0	0	0	0
Wash Out for SAD Part Cohort 4, Dose 180 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Intervention Under Fed Condition STARTED	0	0	0	5	0	0	0	0	0	0	0	0
Intervention Under Fed Condition COMPLETED	0	0	0	5	0	0	0	0	0	0	0	0
Intervention Under Fed Condition NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SAD Part Cohort 1, Dose 5 mg n=6 Participants Oral administration, Single dose 5 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 2, Dose 30 mg n=6 Participants Oral administration, Single dose 30 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 3, Dose 60 mg n=6 Participants Oral administration, Single dose 60 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg, Fasted First, Then Dose 180 mg Fed n=6 Participants Oral administration, Single dose 180 mg oral solution, Fasted First, Then Dose 180 mg Fed C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 5, Dose 240 mg n=6 Participants Oral administration, Single dose 240 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Cohort 6, Dose 300 mg n=6 Participants Oral administration, Single dose 300 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Placebo n=12 Participants Oral administration, Single dose placebo oral solution	MAD Part, Dose 40mg n=6 Participants Oral administration dose 40 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 100mg n=6 Participants Oral administration dose 100 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 140mg n=6 Participants Oral administration dose 140 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 180mg n=6 Participants Oral administration dose 180 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Placebo n=8 Participants Oral administration of placebo oral solution twice daily for 8 days	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	12 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	8 Participants n=42 Participants	80 Participants n=36 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Age, Continuous	38.5 years STANDARD_DEVIATION 11.7 • n=5 Participants	47.2 years STANDARD_DEVIATION 12.9 • n=7 Participants	35.0 years STANDARD_DEVIATION 9.4 • n=5 Participants	40.2 years STANDARD_DEVIATION 16.2 • n=4 Participants	38.7 years STANDARD_DEVIATION 14.0 • n=21 Participants	50.8 years STANDARD_DEVIATION 17.0 • n=8 Participants	46.5 years STANDARD_DEVIATION 14.4 • n=8 Participants	39.3 years STANDARD_DEVIATION 10.6 • n=24 Participants	29.0 years STANDARD_DEVIATION 5.3 • n=42 Participants	31.3 years STANDARD_DEVIATION 7.1 • n=42 Participants	37.2 years STANDARD_DEVIATION 9.9 • n=42 Participants	36.6 years STANDARD_DEVIATION 13.0 • n=42 Participants	39.7 years STANDARD_DEVIATION 13.0 • n=36 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	14 Participants n=36 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=8 Participants	9 Participants n=8 Participants	5 Participants n=24 Participants	6 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	7 Participants n=42 Participants	66 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	11 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	8 Participants n=42 Participants	75 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Region of Enrollment Sweden	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	6 participants n=21 Participants	6 participants n=8 Participants	12 participants n=8 Participants	6 participants n=24 Participants	6 participants n=42 Participants	6 participants n=42 Participants	6 participants n=42 Participants	8 participants n=42 Participants	80 participants n=36 Participants

PRIMARY outcome

Timeframe: From date of signing informed consent until End of Study, assessed up to Day 22

Population: SAD: The withdrawn subject was part of Cohort 4 fed condition. .The subject was excluded from the trial before completing the food interaction visit. MAD: Two (2) subjects in the 100 mg C106 dose group had AEs (common cold) that lead to subject withdrawal from the trial.

Outcome measures

Outcome measures
Measure	SAD Part Cohort 1, Dose 5 mg n=6 Participants Oral administration, Single dose 5 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 2, Dose 30 mg n=6 Participants Oral administration, Single dose 30 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 3, Dose 60 mg n=6 Participants Oral administration, Single dose 60 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg n=6 Participants Oral administration, Single dose 180 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg Fed n=5 Participants Oral administration, Single dose 180 mg oral solution in fed condition. C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 5, Dose 240 mg n=6 Participants Oral administration, Single dose 240 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Cohort 6, Dose 300 mg n=6 Participants Oral administration, Single dose 300 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Placebo n=12 Participants Oral administration, Single dose placebo oral solution	MAD Part, Dose 40mg n=6 Participants Oral administration dose 40 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 100mg n=6 Participants Oral administration dose 100 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 140mg n=6 Participants Oral administration dose 140 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 180mg n=6 Participants Oral administration dose 180 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Placebo n=8 Participants Oral administration of placebo oral solution twice daily for 8 days
Total Number of Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs) Adverse events	5 Number of events	5 Number of events	3 Number of events	2 Number of events	2 Number of events	7 Number of events	8 Number of events	4 Number of events	11 Number of events	10 Number of events	15 Number of events	7 Number of events	21 Number of events
Total Number of Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs) Serious Adverse events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events

PRIMARY outcome

Timeframe: Part A: Up to Day 10. Part B: Up to Day 22.

Population: Data were presented using summary statistics..

Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. Abnormalities will be specified and documented as clinically significant or not clinically significant. Heart rate (HR) and PR, QRS, QT, and QTcF intervals were recorded.

Outcome measures

Outcome measures
Measure	SAD Part Cohort 1, Dose 5 mg n=6 Participants Oral administration, Single dose 5 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 2, Dose 30 mg n=6 Participants Oral administration, Single dose 30 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 3, Dose 60 mg n=6 Participants Oral administration, Single dose 60 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg n=6 Participants Oral administration, Single dose 180 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg Fed n=5 Participants Oral administration, Single dose 180 mg oral solution in fed condition. C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 5, Dose 240 mg n=6 Participants Oral administration, Single dose 240 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Cohort 6, Dose 300 mg n=6 Participants Oral administration, Single dose 300 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Placebo n=12 Participants Oral administration, Single dose placebo oral solution	MAD Part, Dose 40mg n=6 Participants Oral administration dose 40 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 100mg n=6 Participants Oral administration dose 100 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 140mg n=6 Participants Oral administration dose 140 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 180mg n=6 Participants Oral administration dose 180 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Placebo n=8 Participants Oral administration of placebo oral solution twice daily for 8 days
Number of Reported Clinically Significant Changes From Baseline in 12-lead Electrocardiograms (ECGs)	0 Number of events	0 Number of events	1 Number of events	0 Number of events	0 Number of events	1 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	1 Number of events	0 Number of events	0 Number of events

PRIMARY outcome

Timeframe: Part A: Up to Day 3, Part B: Up to Day 10. Vital signs were measured at pre-defined timepoints during the trial.

Population: Data were presented using summary statistics.

Systolic and diastolic blood pressure and pulse were measured in supine position after 10 minutes of rest. The respiratory rate was assessed. Body temperature was measured using a digital thermometer on Day -1 of each part.

Outcome measures

Outcome measures
Measure	SAD Part Cohort 1, Dose 5 mg n=6 Participants Oral administration, Single dose 5 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 2, Dose 30 mg n=6 Participants Oral administration, Single dose 30 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 3, Dose 60 mg n=6 Participants Oral administration, Single dose 60 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg n=6 Participants Oral administration, Single dose 180 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg Fed n=5 Participants Oral administration, Single dose 180 mg oral solution in fed condition. C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 5, Dose 240 mg n=6 Participants Oral administration, Single dose 240 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Cohort 6, Dose 300 mg n=6 Participants Oral administration, Single dose 300 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Placebo n=12 Participants Oral administration, Single dose placebo oral solution	MAD Part, Dose 40mg n=6 Participants Oral administration dose 40 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 100mg n=6 Participants Oral administration dose 100 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 140mg n=6 Participants Oral administration dose 140 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 180mg n=6 Participants Oral administration dose 180 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Placebo n=8 Participants Oral administration of placebo oral solution twice daily for 8 days
Number of Reported Clinically Significant Changes in Vital Signs Blood pressure	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	1 Number of events	1 Number of events	0 Number of events	0 Number of events	0 Number of events	1 Number of events	0 Number of events	0 Number of events
Number of Reported Clinically Significant Changes in Vital Signs Pulse	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events
Number of Reported Clinically Significant Changes in Vital Signs Respiratory rate	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	2 Number of events	1 Number of events	0 Number of events	1 Number of events	2 Number of events

PRIMARY outcome

Timeframe: Part A: Up to Day 3, Part B: Up to Day 10. Safety laboratory samples were collected at pre-defined timepoints during the trial.

Population: Data were presented using summary statistics.

Blood samples for analysis of clinical chemistry, haematology, and coagulation parameters were collected through venepuncture or an indwelling venous catheter.

Outcome measures

Outcome measures
Measure	SAD Part Cohort 1, Dose 5 mg n=6 Participants Oral administration, Single dose 5 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 2, Dose 30 mg n=6 Participants Oral administration, Single dose 30 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 3, Dose 60 mg n=6 Participants Oral administration, Single dose 60 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg n=6 Participants Oral administration, Single dose 180 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg Fed n=5 Participants Oral administration, Single dose 180 mg oral solution in fed condition. C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 5, Dose 240 mg n=6 Participants Oral administration, Single dose 240 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Cohort 6, Dose 300 mg n=6 Participants Oral administration, Single dose 300 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Placebo n=12 Participants Oral administration, Single dose placebo oral solution	MAD Part, Dose 40mg n=6 Participants Oral administration dose 40 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 100mg n=6 Participants Oral administration dose 100 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 140mg n=6 Participants Oral administration dose 140 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 180mg n=6 Participants Oral administration dose 180 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Placebo n=8 Participants Oral administration of placebo oral solution twice daily for 8 days
Number of Clinically Significant Changes in Laboratory Safety Variables (Haematology, Coagulation, Clinical Chemistry and Urine Analysis) Clinical chemistry	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	1 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events
Number of Clinically Significant Changes in Laboratory Safety Variables (Haematology, Coagulation, Clinical Chemistry and Urine Analysis) Haematology	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events
Number of Clinically Significant Changes in Laboratory Safety Variables (Haematology, Coagulation, Clinical Chemistry and Urine Analysis) Coagulation	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events
Number of Clinically Significant Changes in Laboratory Safety Variables (Haematology, Coagulation, Clinical Chemistry and Urine Analysis) Urinalysis	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events

PRIMARY outcome

Timeframe: Physical examination was performed at pre-defined timepoints during the trial. Part A: Day 7, Part B: Day 22

Population: Data were presented using summary statistics.

Any abnormalities will be specified and documented as clinically significant or not clinically significant. Abnormal findings assessed as clinically significant will be reported as AEs. A complete physical examination will include assessments of the head, eyes, ears, nose, throat, skin, neurological, lungs, cardiovascular, and abdomen. .

Outcome measures

Outcome measures
Measure	SAD Part Cohort 1, Dose 5 mg n=6 Participants Oral administration, Single dose 5 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 2, Dose 30 mg n=6 Participants Oral administration, Single dose 30 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 3, Dose 60 mg n=6 Participants Oral administration, Single dose 60 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg n=6 Participants Oral administration, Single dose 180 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg Fed n=5 Participants Oral administration, Single dose 180 mg oral solution in fed condition. C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 5, Dose 240 mg n=6 Participants Oral administration, Single dose 240 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Cohort 6, Dose 300 mg n=6 Participants Oral administration, Single dose 300 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Placebo n=12 Participants Oral administration, Single dose placebo oral solution	MAD Part, Dose 40mg n=6 Participants Oral administration dose 40 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 100mg n=6 Participants Oral administration dose 100 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 140mg n=6 Participants Oral administration dose 140 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 180mg n=6 Participants Oral administration dose 180 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Placebo n=8 Participants Oral administration of placebo oral solution twice daily for 8 days
Number of Reported Clinically Significant Changes in Physical Examinations.	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events	0 Number of events

Deaths: 0 deaths

MAD Part, Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SAD Part Cohort 1, Dose 5 mg n=6 participants at risk Oral administration, Single dose 5 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 2, Dose 30 mg n=6 participants at risk Oral administration, Single dose 30 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 3, Dose 60 mg n=6 participants at risk Oral administration, Single dose 60 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg n=6 participants at risk Oral administration, Single dose 180 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 4, Dose 180 mg Fed n=5 participants at risk Oral administration, Single dose 180 mg oral solution in fed condition. C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part Cohort 5, Dose 240 mg n=6 participants at risk Oral administration, Single dose 240 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Cohort 6, Dose 300 mg n=6 participants at risk Oral administration, Single dose 300 mg oral solution C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	SAD Part, Placebo n=12 participants at risk Oral administration, Single dose placebo oral solution	MAD Part, Dose 40mg n=6 participants at risk Oral administration dose 40 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 100mg n=6 participants at risk Oral administration dose 100 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 140mg n=6 participants at risk Oral administration dose 140 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Dose 180mg n=6 participants at risk Oral administration dose 180 mg twice daily for 8 days C106 solution: selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist	MAD Part, Placebo n=8 participants at risk Oral administration of placebo oral solution twice daily for 8 days
General disorders Chest pain	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Nervous system disorders Headache	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	33.3% 2/6 • Number of events 2 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	20.0% 1/5 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	33.3% 2/6 • Number of events 3 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	50.0% 3/6 • Number of events 5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 4 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	50.0% 4/8 • Number of events 5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Nervous system disorders Paraesthesia	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 2 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	12.5% 1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Nervous system disorders Restless legs syndrome	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Nervous system disorders Dysgeusia	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	12.5% 1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Nervous system disorders Hypoesthesia	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
General disorders Fatigue	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	8.3% 1/12 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
General disorders Malaise	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
General disorders Pain	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
General disorders Swelling	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
General disorders Chest discomfort	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	12.5% 1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
General disorders Feeling hot	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	12.5% 1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Gastrointestinal disorders Constipation	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Gastrointestinal disorders Flatulence	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	25.0% 2/8 • Number of events 3 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Gastrointestinal disorders Nausea	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	12.5% 1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 3 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	20.0% 1/5 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	8.3% 1/12 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Injury, poisoning and procedural complications Vascular access site inflammation	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Skin and subcutaneous tissue disorders Skin burning sensation	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Cardiac disorders Atrioventricular block second degree	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Cardiac disorders Bradycardia	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Cardiac disorders Atrioventricular block first degree	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	12.5% 1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Infections and infestations Rhinitis	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Infections and infestations Tooth infection	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Infections and infestations Nasopharyngitis	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	33.3% 2/6 • Number of events 2 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	12.5% 1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Investigations Blood pressure increased	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	33.3% 2/6 • Number of events 2 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Investigations Respiratory rate decreased	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	33.3% 2/6 • Number of events 2 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	25.0% 2/8 • Number of events 2 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Eye disorders Blepharospasm	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	8.3% 1/12 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Eye disorders Eye paraesthesia	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	12.5% 1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	8.3% 1/12 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	12.5% 1/8 • Number of events 2 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Psychiatric disorders Irritability	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	12.5% 1/8 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Respiratory, thoracic and mediastinal disorders Nasal pruritus	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Renal and urinary disorders Bladder pain	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.
Renal and urinary disorders Urinary incontinence	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/5 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/12 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	16.7% 1/6 • Number of events 1 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/6 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.	0.00% 0/8 • AEs (including serious AEs [SAEs]) were collected from the signing of the informed consent form until the end-of-trial visit for each subject, ranging from up to 37 days in SAD part to up to 47 days in MAD part. The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. The causal relationship between AEs and the IMP was assessed as related, not related or not applicable.

Additional Information

Cecilia Ganslandt, MD, MSc, Global Medical Director

Vicore Pharma AB

Phone: +46 317880560

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place