Trial Outcomes & Findings for Safety and Tolerability of Single and Multiple Doses of Neumifil (NCT NCT05093530)

NCT ID: NCT05093530

Last Updated: 2024-01-11

Results Overview

Number of participants with Treatment Emergent Adverse Events

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

7 days

Results posted on

2024-01-11

Participant Flow

This was a first in human study in healthy participants at a single site in the UK. The first participant was screened on 07 October 2021 and the last participant visit was on 05 April 2022.

Participant milestones

Participant milestones
Measure	Part A Placebo All Groups Placebo single dose for all groups	Part A1 Neumifil 0.028mg Neumifil 0.028mg single dose	Part A2 Neumifil 0.085mg Neumifil 0.085mg single dose	Part A3 Neumifil 0.28mg Neumifil 0.28mg single dose	Part A4 Neumifil 0.885mg Neumifil 0.885mg single dose	Part A5 Neumifil 2.8mg Neumifil 2.8mg single dose	Part B Placebo All Groups Placebo once daily for 7 days for all.groups	Part B1 Neumifil 0.28mg Neumifil 0.28mg once daily for 7 days	Part B2 Neumifil 0.885mg Neumifil 0.885mg once daily for 7 days	Part B3 Neumifil 2.8mg Neumifil 2.8mg once daily for 7 days
Overall Study STARTED	12	4	4	4	6	6	6	6	6	6
Overall Study COMPLETED	12	4	4	4	6	6	5	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	1	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Tolerability of Single and Multiple Doses of Neumifil

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A Placebo All Groups n=12 Participants Placebo will be administered intranasally using an Aptar deliver system. Each dose will consist of 0.5ml to each nostril.	Part A1 Neumifil 0.028mg n=4 Participants Neumifil 0.028mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A2 Neumifil 0.085mg n=4 Participants Neumifil 0.085mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A3 Neumifil 0.28mg n=4 Participants Neumifil 0.028mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A4 Neumifil 0.885mg n=6 Participants Neumifil 0.085mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A5 Neumifil 2.8mg n=6 Participants Neumifil 2.8 mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part B Placebo All Groups n=6 Participants Placebo will be administered intranasally once daily for 7 days using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part B1 Neumifil 0.28mg n=6 Participants Neumifil 0.28mg will be administered intranasally once daily for 7 days using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part B2 Neumifil 0.885mg n=6 Participants Neumifil 0.885mg will be administered intranasally once daily for 7 days using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part B3 Neumifil 2.8mg n=6 Participants Neumifil 2.8mg will be administered intranasally once daily for 7 days using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Total n=60 Participants Total of all reporting groups
Age, Continuous	43.3 years STANDARD_DEVIATION 12.16 • n=5 Participants	34.0 years STANDARD_DEVIATION 5.89 • n=7 Participants	35.0 years STANDARD_DEVIATION 14.85 • n=5 Participants	31.5 years STANDARD_DEVIATION 17.23 • n=4 Participants	32.2 years STANDARD_DEVIATION 12.94 • n=21 Participants	27.7 years STANDARD_DEVIATION 3.67 • n=10 Participants	41.2 years STANDARD_DEVIATION 15.32 • n=115 Participants	38.8 years STANDARD_DEVIATION 15.51 • n=24 Participants	32.7 years STANDARD_DEVIATION 12.19 • n=42 Participants	38.3 years STANDARD_DEVIATION 13.53 • n=42 Participants	35.6 years STANDARD_DEVIATION 12.46 • n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	16 Participants n=42 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	44 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	58 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Region of Enrollment United Kingdom	12 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	6 participants n=21 Participants	6 participants n=10 Participants	6 participants n=115 Participants	6 participants n=24 Participants	6 participants n=42 Participants	6 participants n=42 Participants	60 participants n=42 Participants

PRIMARY outcome

Timeframe: 7 days

Number of participants with Treatment Emergent Adverse Events

Outcome measures

Outcome measures
Measure	Part A Placebo All Groups n=12 Participants Placebo will be administered intranasally using an Aptar deliver system. Each dose will consist of 0.5ml to each nostril.	Part A1 Neumifil 0.028mg n=4 Participants Neumifil 0.028mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A2 Neumifil 0.085mg n=4 Participants Neumifil 0.085mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A3 Neumifil 0.28mg n=4 Participants Neumifil 0.028mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A4 0.Neumifil 0.885mg n=6 Participants Neumifil 0.085mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A5 Neumifil 2.8mg n=6 Participants Neumifil 2.8 mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.
Part A Treatment Emergent Adverse Events	4 Participants	3 Participants	2 Participants	3 Participants	5 Participants	5 Participants

PRIMARY outcome

Timeframe: 14 days after last dose

Number of participants with Treatment Emergent Adverse Events

Outcome measures

Outcome measures
Measure	Part A Placebo All Groups n=6 Participants Placebo will be administered intranasally using an Aptar deliver system. Each dose will consist of 0.5ml to each nostril.	Part A1 Neumifil 0.028mg n=6 Participants Neumifil 0.028mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A2 Neumifil 0.085mg n=6 Participants Neumifil 0.085mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A3 Neumifil 0.28mg n=6 Participants Neumifil 0.028mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A4 0.Neumifil 0.885mg Neumifil 0.085mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A5 Neumifil 2.8mg Neumifil 2.8 mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.
Part B: Treatment Emergent Adverse Events	5 Participants	6 Participants	5 Participants	6 Participants	—	—

PRIMARY outcome

Timeframe: 7 days

Number of participants with clinically significant changes in:vital signs (heart rate, blood pressure, respiratory rate, pulse oximetry and temperature), 12-lead electrocardiogram (ECG), Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), physical examination, nasal examination, laboratory safety tests (haematology, biochemistry and urinalysis), tolerability questionnaire

Outcome measures

Outcome measures
Measure	Part A Placebo All Groups n=12 Participants Placebo will be administered intranasally using an Aptar deliver system. Each dose will consist of 0.5ml to each nostril.	Part A1 Neumifil 0.028mg n=4 Participants Neumifil 0.028mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A2 Neumifil 0.085mg n=4 Participants Neumifil 0.085mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A3 Neumifil 0.28mg n=4 Participants Neumifil 0.028mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A4 0.Neumifil 0.885mg n=6 Participants Neumifil 0.085mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A5 Neumifil 2.8mg n=6 Participants Neumifil 2.8 mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.
Part A: Clinically Significant Changes in Safety Tests	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 14 days after last dose

Number of participants with clinically significant changes in: vital signs (heart rate, blood pressure, respiratory rate, pulse oximetry and temperature), 12-lead electrocardiogram (ECG), FEV1, FVC, physical examination, nasal examination, laboratory safety tests (haematology, biochemistry and urinalysis), tolerability questionnaire

Outcome measures

Outcome measures
Measure	Part A Placebo All Groups n=6 Participants Placebo will be administered intranasally using an Aptar deliver system. Each dose will consist of 0.5ml to each nostril.	Part A1 Neumifil 0.028mg n=6 Participants Neumifil 0.028mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A2 Neumifil 0.085mg n=6 Participants Neumifil 0.085mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A3 Neumifil 0.28mg n=6 Participants Neumifil 0.028mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A4 0.Neumifil 0.885mg Neumifil 0.085mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.	Part A5 Neumifil 2.8mg Neumifil 2.8 mg as a single dose administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril.
Part B:Clinically Significant Changes in Safety Tests	1 Participants	0 Participants	0 Participants	0 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, before first dose, Day 8 (Part B only), follow-up (Part A: Day 8 to 9); Part B: Day 21 to 23)

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part A Placebo All Groups n=12 participants at risk Placebo single dose for all groups	Part A1 Neumifil 0.028mg n=4 participants at risk Neumifil 0.028mg single dose	Part A2 Neumifil 0.085mg n=4 participants at risk Neumifil 0.085mg single dose	Part A3 Neumifil 0.28mg n=4 participants at risk Neumifil 0.28mg single dose	Part A4 Neumifil 0.885mg n=6 participants at risk Neumifil 0.885mg single dose	Part A5 Neumifil 2.8mg n=6 participants at risk Neumifil 2.8mg single dose	Part B Placebo All Groups n=6 participants at risk Placebo once daily for 7 days for all.groups	Part B1 Neumifil 0.28mg n=6 participants at risk Neumifil 0.28mg once daily for 7 days	Part B2 Neumifil 0.885mg n=6 participants at risk Neumifil 0.885mg once daily for 7 days	Part B3 Neumifil 2.8mg n=6 participants at risk Neumifil 2.8mg once daily for 7 days
Respiratory, thoracic and mediastinal disorders Nasal discomfort	25.0% 3/12 • Number of events 3 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	25.0% 1/4 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	50.0% 2/4 • Number of events 2 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	50.0% 2/4 • Number of events 4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	66.7% 4/6 • Number of events 5 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	66.7% 4/6 • Number of events 9 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	50.0% 3/6 • Number of events 5 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	66.7% 4/6 • Number of events 4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	50.0% 3/6 • Number of events 5 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	50.0% 3/6 • Number of events 6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Respiratory, thoracic and mediastinal disorders Sneezing	8.3% 1/12 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	25.0% 1/4 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	50.0% 3/6 • Number of events 3 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Product Issues Product after taste	16.7% 2/12 • Number of events 2 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	50.0% 2/4 • Number of events 2 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	50.0% 2/4 • Number of events 2 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	66.7% 4/6 • Number of events 4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	33.3% 2/6 • Number of events 2 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	33.3% 2/6 • Number of events 2 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	66.7% 4/6 • Number of events 4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	50.0% 3/6 • Number of events 3 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	33.3% 2/6 • Number of events 2 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
General disorders Discomfort	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	25.0% 1/4 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
General disorders Cather site pain	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
General disorders Fatigue	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Infections and infestations COVID-19	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	33.3% 2/6 • Number of events 2 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Nervous system disorders Headache	8.3% 1/12 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Infections and infestations Rhinitis	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Nervous system disorders Parosmia	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	33.3% 2/6 • Number of events 2 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Nervous system disorders Taste disorder	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	33.3% 2/6 • Number of events 2 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Gastrointestinal disorders Hypothesia oral	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Psychiatric disorders Panic attack	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)
Nervous system disorders Somnolence	0.00% 0/12 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/4 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	16.7% 1/6 • Number of events 1 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)	0.00% 0/6 • Adverse events were collected up to 7 days after single dose groups (all Part A groups) and 14 days after the last dose for multiple dose groups (all Part B groups)

Additional Information

CEO

Pneumagen Ltd

Phone: +44 7748357352

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place