Trial Outcomes & Findings for RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients (NCT NCT02257177)

NCT ID: NCT02257177

Last Updated: 2023-11-07

Results Overview

Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

60 participants

Primary outcome timeframe

0 - 30 days

Results posted on

2023-11-07

Participant Flow

A total of 60 subjects were randomised, 39 randomized to treatment, with 24 subjects in Part 1 and 15 subjects in Part 2.

Participant milestones

Participant milestones
Measure	0.15 mg TD139 (Part 1) 4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	1.5 mg TD139 (Part 1) 4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	3 mg TD139 (Part 1) 4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	10 mg TD139 Part 1 4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	20 mg TD139 Part 1 4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	50 mg TD139 Part 1 4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	Placebo Part 1 12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Placebo: DPI placebo	0.3 mg TD139 Part 2 5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.	3 mg TD139 Part 2 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.	10 mg TD139 Part 2 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.	Placebo Part 2 9 Patients with IPF are administered placebo inhaled as a dry powder.
Overall Study STARTED	4	4	4	4	4	4	12	5	5	5	9
Overall Study COMPLETED	4	4	4	4	4	4	12	5	5	4	9
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.15 mg TD139 (Part 1) n=4 Participants 4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	1.5 mg TD139 (Part 1) n=4 Participants 4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	3 mg TD139 (Part 1) n=4 Participants 4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	10 mg TD139 Part 1 n=4 Participants 4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	20 mg TD139 Part 1 n=4 Participants 4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	50 mg TD139 Part 1 n=4 Participants 4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	Placebo Part 1 n=12 Participants 12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Placebo: DPI placebo	0.3 mg TD139 Part 2 n=5 Participants 5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.	3 mg TD139 Part 2 n=5 Participants 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.	10 mg TD139 Part 2 n=5 Participants 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.	Placebo Part 2 n=9 Participants 9 Patients with IPF are administered placebo inhaled as a dry powder.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	12 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	38 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	9 Participants n=42 Participants	22 Participants n=42 Participants
Age, Continuous	42.3 Years STANDARD_DEVIATION 9.07 • n=5 Participants	29.8 Years STANDARD_DEVIATION 6.80 • n=7 Participants	39.3 Years STANDARD_DEVIATION 10.21 • n=5 Participants	29.8 Years STANDARD_DEVIATION 2.06 • n=4 Participants	30.8 Years STANDARD_DEVIATION 9.54 • n=21 Participants	32.8 Years STANDARD_DEVIATION 9.91 • n=8 Participants	35.6 Years STANDARD_DEVIATION 7.53 • n=8 Participants	69.0 Years STANDARD_DEVIATION 6.32 • n=24 Participants	73.6 Years STANDARD_DEVIATION 5.86 • n=42 Participants	79.2 Years STANDARD_DEVIATION 2.77 • n=42 Participants	72.9 Years STANDARD_DEVIATION 4.59 • n=42 Participants	50.2 Years STANDARD_DEVIATION 20.63 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	12 Participants n=8 Participants	4 Participants n=24 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	9 Participants n=42 Participants	59 Participants n=42 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	4 participants n=21 Participants	4 participants n=8 Participants	12 participants n=8 Participants	5 participants n=24 Participants	5 participants n=42 Participants	5 participants n=42 Participants	9 participants n=42 Participants	60 participants n=42 Participants

PRIMARY outcome

Timeframe: 0 - 30 days

Population: All subjects in Part 1 are included in the safety population. The safety population includes all subjects who received at least one dose of study treatment (TD139 or Placebo). Safety parameters are listed and summarised using descriptive statistics. No formal statistical analysis is planned.

Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.

Outcome measures

Outcome measures
Measure	0.15 mg TD139 (Part 1) n=4 Participants 4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	1.5 mg TD139 (Part 1) n=4 Participants 4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	3 mg TD139 (Part 1) n=4 Participants 4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	10 mg TD139 Part 1 n=4 Participants 4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	20 mg TD139 Part 1 n=4 Participants 4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	50 mg TD139 Part 1 n=4 Participants 4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	Placebo Part 1 n=12 Participants 12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Placebo: DPI placebo	0.3 mg TD139 Part 2 n=5 Participants 5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.	3 mg TD139 Part 2 n=5 Participants 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.	10 mg TD139 Part 2 n=5 Participants 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.	Placebo Part 2 n=9 Participants 9 Patients with IPF are administered placebo inhaled as a dry powder.
Number of Participants With Adverse Events	0 Participants	0 Participants	2 Participants	3 Participants	4 Participants	4 Participants	2 Participants	4 Participants	5 Participants	4 Participants	7 Participants

Deaths: 1 deaths

Placebo Part 2

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0.15 mg TD139 (Part 1) n=4 participants at risk 4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	1.5 mg TD139 (Part 1) n=4 participants at risk 4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	3 mg TD139 (Part 1) n=4 participants at risk 4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	10 mg TD139 Part 1 n=4 participants at risk 4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	20 mg TD139 Part 1 n=4 participants at risk 4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	50 mg TD139 Part 1 n=4 participants at risk 4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	Placebo Part 1 n=12 participants at risk 12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Placebo: DPI placebo	0.3 mg TD139 Part 2 n=5 participants at risk 5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.	3 mg TD139 Part 2 n=5 participants at risk 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.	10 mg TD139 Part 2 n=5 participants at risk 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.	Placebo Part 2 n=9 participants at risk 9 Patients with IPF are administered placebo inhaled as a dry powder.
Infections and infestations Pneumonia	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose

Other adverse events

Other adverse events
Measure	0.15 mg TD139 (Part 1) n=4 participants at risk 4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	1.5 mg TD139 (Part 1) n=4 participants at risk 4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	3 mg TD139 (Part 1) n=4 participants at risk 4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	10 mg TD139 Part 1 n=4 participants at risk 4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	20 mg TD139 Part 1 n=4 participants at risk 4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	50 mg TD139 Part 1 n=4 participants at risk 4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Inhaled TD139: DPI Galectin-3 inhibitor	Placebo Part 1 n=12 participants at risk 12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later. Placebo: DPI placebo	0.3 mg TD139 Part 2 n=5 participants at risk 5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.	3 mg TD139 Part 2 n=5 participants at risk 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.	10 mg TD139 Part 2 n=5 participants at risk 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.	Placebo Part 2 n=9 participants at risk 9 Patients with IPF are administered placebo inhaled as a dry powder.
Nervous system disorders Dysgeusia	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	75.0% 3/4 • Number of events 3 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	100.0% 4/4 • Number of events 4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	100.0% 4/4 • Number of events 4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	16.7% 2/12 • Number of events 2 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	50.0% 2/4 • Number of events 2 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	40.0% 2/5 • Number of events 2 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Nervous system disorders Headache	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	50.0% 2/4 • Number of events 2 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 3 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	22.2% 2/9 • Number of events 2 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 2 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 2 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Nervous system disorders Dizziness	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Infections and infestations Nasopharyngitis	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	25.0% 1/4 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 2 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Endocrine disorders Adrenal Suppression	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Gastrointestinal disorders Vomiting	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
General disorders Chills	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
General disorders Fatigue	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
General disorders Pyrexia	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 3 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
General disorders Vessel Puncture Site Pain	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Infections and infestations Ear Infection	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Infections and infestations Localised Infection	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Infections and infestations Urinary Tract Infection	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Musculoskeletal and connective tissue disorders Gout	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Nervous system disorders Sinus Headache	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Renal and urinary disorders Bladder and Urethral Symptoms	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Renal and urinary disorders Urinary Retention	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	20.0% 1/5 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/9 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Respiratory, thoracic and mediastinal disorders Upper-airway Cough Syndrome	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Skin and subcutaneous tissue disorders Actinic Keratosis	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Skin and subcutaneous tissue disorders Seborrheic dermatitis	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/4 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/12 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	0.00% 0/5 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose	11.1% 1/9 • Number of events 1 • Adverse Events are measured from the administration of the first dose, until 30 days post first dose

Additional Information

Professor Bertil Lindmark

Galecto

Phone: +4570705210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Investigators must agree to maintain the confidentiality of the study at all times and must not reveal any information relating to the study without express permission from the study Sponsor.
Publication restrictions are in place

Restriction type: OTHER