Trial Outcomes & Findings for A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401 (NCT NCT01627002)

NCT ID: NCT01627002

Last Updated: 2013-09-23

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

49 participants

Primary outcome timeframe

up to 14 days post dose

Results posted on

2013-09-23

Participant Flow

The study was conducted from June 2012 (first subject dosed) to April 2013 (last subject visit). The study was conducted in 2 parts; Part A was a single ascending dose study, Part B was a randomised placebo-controlled study to investigate the effect of a single dose of PA401 on sputum neutrophils following inhaled lipopolysaccharide challenge

In Part B, subjects were included at baseline if they had a baseline neutrophil level in induced sputum of ≤70%

Participant milestones

Participant milestones
Measure	Part A PA401 0.1 mg	Part A PA401 0.3 mg	Part A PA401 1.0 mg	Part A PA401 3.0 mg	Part A PA401 10 mg	Part A Placebo	Part B PA401 1.0 mg PA401 1.0 mg was administered 30 minutes after lipopolysaccharide challenge	Part B PA401 3.0 mg PA401 3.0 mg was administered 30 minutes after lipopolysaccharide challenge	Part B Placebo Placebo was administered 30 minutes after lipopolysaccharide challenge
Overall Study STARTED	4	4	4	4	2	9	10	5	7
Overall Study COMPLETED	4	4	4	4	2	9	10	5	7
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A n=27 Participants	Part B n=22 Participants	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=93 Participants	22 Participants n=4 Participants	49 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	27 Participants n=93 Participants	22 Participants n=4 Participants	49 Participants n=27 Participants
Region of Enrollment United Kingdom	27 participants n=93 Participants	22 participants n=4 Participants	49 participants n=27 Participants

PRIMARY outcome

Timeframe: up to 14 days post dose

Population: Safety analyses were performed on all subjects who receive a dose of PA401 or placebo and who had any post-dose measurements

Outcome measures

Outcome measures
Measure	Part A PA401 0.1 mg n=4 Participants	Part A PA401 0.3 mg n=4 Participants	Part A PA401 1.0 mg n=4 Participants	Part A PA401 3.0 mg n=4 Participants	Part A PA401 10 mg n=2 Participants	Part A Placebo n=9 Participants	Part B PA401 1.0 mg n=10 Participants	Part B PA401 3.0 mg n=5 Participants	Part B Placebo n=7 Participants
Treatment Emergent Adverse Events	3 Participants	3 Participants	4 Participants	2 Participants	2 Participants	3 Participants	7 Participants	5 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to 28 days post dose

Population: Safety analyses were performed on all subjects who received a dose of PA401 or placebo and who had any post-dose assessments

Anti-drug antibody data

Outcome measures

Outcome measures
Measure	Part A PA401 0.1 mg n=4 Participants	Part A PA401 0.3 mg n=4 Participants	Part A PA401 1.0 mg n=4 Participants	Part A PA401 3.0 mg n=4 Participants	Part A PA401 10 mg n=2 Participants	Part A Placebo n=9 Participants	Part B PA401 1.0 mg n=10 Participants	Part B PA401 3.0 mg n=5 Participants	Part B Placebo n=7 Participants
Immunogenicity Day 29 ADA positive and cross-reactive with IL-8	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Immunogenicity Day 1 anti-drug antibody (ADA) positive	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Immunogenicity Day 1 ADA positive and cross-reactive with IL-8	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Immunogenicity Day 1 Pre-existing IL-8 autoantibodies	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Immunogenicity Day 15 ADA positive	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Immunogenicity Day 15 ADA positive and cross-reactive with IL-8	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Immunogenicity Day 15 Pre-existing IL-8 autoantibodies	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Immunogenicity Day 29 ADA positive	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Immunogenicity Day 29 Pre-existing IL-8 autoantibodies	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: 5.5 hours post dose

Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils

Outcome measures

Outcome measures
Measure	Part A PA401 0.1 mg n=5 Participants	Part A PA401 0.3 mg n=10 Participants	Part A PA401 1.0 mg n=7 Participants	Part A PA401 3.0 mg	Part A PA401 10 mg	Part A Placebo	Part B PA401 1.0 mg	Part B PA401 3.0 mg	Part B Placebo
Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils	11.6882 x10e6 cells/g Interval 2.8474 to 20.529	7.7274 x10e6 cells/g Interval 1.4038 to 14.0511	12.7241 x10e6 cells/g Interval 5.1749 to 20.2733	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 12 time-points up to 48 hours post dose

Outcome measures

Outcome measures
Measure	Part A PA401 0.1 mg n=4 Participants	Part A PA401 0.3 mg n=4 Participants	Part A PA401 1.0 mg n=8 Participants	Part A PA401 3.0 mg n=5 Participants	Part A PA401 10 mg	Part A Placebo	Part B PA401 1.0 mg	Part B PA401 3.0 mg	Part B Placebo
Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)	1.88 ng/mL Standard Deviation 0.587	7.51 ng/mL Standard Deviation 2.64	1.29 ng/mL Standard Deviation 0.411	2.85 ng/mL Standard Deviation 0.805	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 12 time-points up to 48 hours post dose

Outcome measures

Outcome measures
Measure	Part A PA401 0.1 mg n=4 Participants	Part A PA401 0.3 mg n=4 Participants	Part A PA401 1.0 mg n=8 Participants	Part A PA401 3.0 mg n=5 Participants	Part A PA401 10 mg	Part A Placebo	Part B PA401 1.0 mg	Part B PA401 3.0 mg	Part B Placebo
Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)	2.75 hours Standard Deviation 0.87	2.02 hours Standard Deviation 0.40	2.09 hours Standard Deviation 0.53	2.20 hours Standard Deviation 1.10	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 12 time-points up to 48 hours post dose

Outcome measures

Outcome measures
Measure	Part A PA401 0.1 mg n=4 Participants	Part A PA401 0.3 mg n=4 Participants	Part A PA401 1.0 mg n=8 Participants	Part A PA401 3.0 mg n=3 Participants	Part A PA401 10 mg	Part A Placebo	Part B PA401 1.0 mg	Part B PA401 3.0 mg	Part B Placebo
Pharmacokinetic Parameters: Terminal Half-life (t1/2)	9.26 hours Standard Deviation 2.57	8.44 hours Standard Deviation 0.846	6.17 hours Standard Deviation 1.79	10.1 hours Standard Deviation 4.47	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 12 time-points up to 48 hours post dose

Outcome measures

Outcome measures
Measure	Part A PA401 0.1 mg n=3 Participants	Part A PA401 0.3 mg n=4 Participants	Part A PA401 1.0 mg n=7 Participants	Part A PA401 3.0 mg n=3 Participants	Part A PA401 10 mg	Part A Placebo	Part B PA401 1.0 mg	Part B PA401 3.0 mg	Part B Placebo
Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity	23.9 ng.h/mL Standard Deviation 9.72	93.2 ng.h/mL Standard Deviation 12.1	12.2 ng.h/mL Standard Deviation 3.82	29.3 ng.h/mL Standard Deviation 5.66	—	—	—	—	—

SECONDARY outcome

Timeframe: 5.5 hours post dose

Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils

Outcome measures

Outcome measures
Measure	Part A PA401 0.1 mg n=5 Participants	Part A PA401 0.3 mg n=10 Participants	Part A PA401 1.0 mg n=7 Participants	Part A PA401 3.0 mg	Part A PA401 10 mg	Part A Placebo	Part B PA401 1.0 mg	Part B PA401 3.0 mg	Part B Placebo
Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils	32.9429 percentage of total cells Interval 26.0955 to 39.7902	36.7007 percentage of total cells Interval 31.7343 to 41.667	34.3856 percentage of total cells Interval 28.436 to 40.3352	—	—	—	—	—	—

Adverse Events

Part A PA401 0.1 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A PA401 0.3 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A PA401 1.0 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A PA401 3.0 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A PA401 10 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B PA401 1.0 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part B PA401 3.0 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part B Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A PA401 0.1 mg n=4 participants at risk	Part A PA401 0.3 mg n=4 participants at risk	Part A PA401 1.0 mg n=4 participants at risk	Part A PA401 3.0 mg n=4 participants at risk	Part A PA401 10 mg n=2 participants at risk	Part A Placebo n=9 participants at risk	Part B PA401 1.0 mg n=10 participants at risk	Part B PA401 3.0 mg n=5 participants at risk	Part B Placebo n=7 participants at risk
Cardiac disorders Atrial Fibrillation	0.00% 0/3 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	50.0% 1/2 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.

Other adverse events

Other adverse events
Measure	Part A PA401 0.1 mg n=4 participants at risk	Part A PA401 0.3 mg n=4 participants at risk	Part A PA401 1.0 mg n=4 participants at risk	Part A PA401 3.0 mg n=4 participants at risk	Part A PA401 10 mg n=2 participants at risk	Part A Placebo n=9 participants at risk	Part B PA401 1.0 mg n=10 participants at risk	Part B PA401 3.0 mg n=5 participants at risk	Part B Placebo n=7 participants at risk
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	80.0% 4/5 • Number of events 4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	14.3% 1/7 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
General disorders Pyrexia	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	50.0% 1/2 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
General disorders Injection Site Pruritus	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	11.1% 1/9 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
General disorders Injection Site Erythema	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	50.0% 2/4 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 2/10 • Number of events 3 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
General disorders Influenza Like Illness	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	30.0% 3/10 • Number of events 4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	28.6% 2/7 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
General disorders Chills	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	50.0% 1/2 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
General disorders Chest Discomfort	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
General disorders Oedema Peripheral	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Ear and labyrinth disorders Tinnitus	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Eye disorders Vision Blurred	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	10.0% 1/10 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Eye disorders Photophobia	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	14.3% 1/7 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	100.0% 2/2 • Number of events 12 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Gastrointestinal disorders Nausea	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	50.0% 1/2 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 2/10 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	40.0% 2/5 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	14.3% 1/7 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Gastrointestinal disorders Gastrointestinal Disorder	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	50.0% 1/2 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Gastrointestinal disorders Abdominal Pain	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	50.0% 1/2 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	10.0% 1/10 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	40.0% 2/5 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	14.3% 1/7 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
General disorders Injection Site Reaction	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	10.0% 1/10 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Infections and infestations Viral Infection	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Infections and infestations Nasopharyngitis	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	50.0% 1/2 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	10.0% 1/10 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Infections and infestations Rhinitis	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	10.0% 1/10 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	14.3% 1/7 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Injury, poisoning and procedural complications Excoriation	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Investigations C-Reactive Protein Increased	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	100.0% 2/2 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Nervous system disorders Headache	50.0% 2/4 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	50.0% 2/4 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	100.0% 2/2 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	33.3% 3/9 • Number of events 3 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	30.0% 3/10 • Number of events 3 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	60.0% 3/5 • Number of events 3 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	28.6% 2/7 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	40.0% 2/5 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Nervous system disorders Disturbance In Attention	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	50.0% 1/2 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Nervous system disorders Syncope	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Nervous system disorders Presyncope	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 2/10 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	40.0% 2/5 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Nervous system disorders Paraesthesia	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Nervous system disorders Lethargy	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	60.0% 3/5 • Number of events 3 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Renal and urinary disorders Dysuria	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	20.0% 1/5 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	25.0% 1/4 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Respiratory, thoracic and mediastinal disorders Throat Irritation	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	10.0% 1/10 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	10.0% 1/10 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/7 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	14.3% 1/7 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Respiratory, thoracic and mediastinal disorders Dry Throat	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	14.3% 1/7 • Number of events 1 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/4 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/9 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/10 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	0.00% 0/5 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.	14.3% 1/7 • Number of events 2 • Up to 14 days post dose Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic.

Additional Information

ProtAffin Biotechnologie AG

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After completion of the study, the Investigator may prepare a joint publication with the Sponsor. The Investigator must undertake not to submit any part of the individual data from this protocol for publication without prior consent of the Sponsor at a mutually agreed time.
Publication restrictions are in place

Restriction type: OTHER