Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of a Subcutaneous and Intravenous Dose of BI 655130 in Healthy Subjects (NCT NCT03100903)

Last Updated: 2025-10-16

Results Overview

AUC0-tz, area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point is presented. As defined in the statistical analysis plan, this outcome measure was analysed for comparison of subcutaneous (SC) versus intravenous (IV) administration of BI 655130 high dose as part of the primary analysis.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

Pharmacokinetic samples were collected at pre-dose and at 0.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours after drug administration.

Results posted on

2025-10-16

Participant Flow

This was an open-label, parallel group trial investigating two different dose strengths of a single subcutaneous (SC) dose of BI 655130 and one single intravenous (IV) dose of BI 655130.

All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial treatment if any one of the specific entry criteria were not met.

Participant milestones

Participant milestones
Measure	BI 655130 Low Dose SC Subject received single low dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose SC Subject received single high dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose IV Subject received single high dose BI 655130 solution as 30 minutes intravenous (IV) infusion on day 1.
Overall Study STARTED	12	12	12
Overall Study COMPLETED	12	12	11
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 655130 Low Dose SC Subject received single low dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose SC Subject received single high dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose IV Subject received single high dose BI 655130 solution as 30 minutes intravenous (IV) infusion on day 1.
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Safety, Tolerability, and Pharmacokinetics of a Subcutaneous and Intravenous Dose of BI 655130 in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 655130 Low Dose SC n=12 Participants Subject received single low dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose SC n=12 Participants Subject received single high dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose IV n=12 Participants Subject received single high dose BI 655130 solution as 30 minutes intravenous (IV) infusion on day 1.	Total n=36 Participants Total of all reporting groups
Age, Continuous	42.3 Years STANDARD_DEVIATION 7.5 • n=5 Participants	34.3 Years STANDARD_DEVIATION 8.1 • n=7 Participants	38.6 Years STANDARD_DEVIATION 10.7 • n=5 Participants	38.4 Years STANDARD_DEVIATION 9.2 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Pharmacokinetic samples were collected at pre-dose and at 0.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours after drug administration.

Population: Pharmacokinetic (PK) analysis set (PKS) restricted to high dose BI 655130 administration for primary analyses of the primary and secondary outcomes: All subjects of the Treated Set who were administered with BI 655130 high dose treatment and provided at least 1 observation for at least 1 primary or secondary PK endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.

Outcome measures

Outcome measures
Measure	BI 655130 High Dose SC n=12 Participants Subject received single high dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose IV n=11 Participants Subject received single high dose BI 655130 solution as 30 minutes intravenous (IV) infusion on day 1.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	1579.19 Daymicrogram/millilitre [dayμg/mL] Standard Error NA Adjusted geometric standard error = 1.07	2204.35 Daymicrogram/millilitre [dayμg/mL] Standard Error NA Adjusted geometric standard error = 1.07

PRIMARY outcome

Cmax, maximum measured concentration of BI 655130 in plasma is presented. As defined in the statistical analysis plan, this outcome measure was analysed for comparison of subcutaneous (SC) versus intravenous (IV) administration of BI 655130 high dose as part of the primary analysis.

Outcome measures

Outcome measures
Measure	BI 655130 High Dose SC n=12 Participants Subject received single high dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose IV n=11 Participants Subject received single high dose BI 655130 solution as 30 minutes intravenous (IV) infusion on day 1.
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)	33.36 Microgram/millilitre [μg/mL] Standard Error NA Adjusted geometric standard error = 1.08	113.90 Microgram/millilitre [μg/mL] Standard Error NA Adjusted geometric standard error = 1.08

SECONDARY outcome

AUC0-∞, area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 extrapolated to infinity is presented. As defined in the statistical analysis plan, this outcome measure was analysed for comparison of subcutaneous (SC) versus intravenous (IV) administration of BI 655130 high dose as part of the primary analysis.

Outcome measures

Outcome measures
Measure	BI 655130 High Dose SC n=12 Participants Subject received single high dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose IV n=11 Participants Subject received single high dose BI 655130 solution as 30 minutes intravenous (IV) infusion on day 1.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	1600.92 Daymicrogram/millilitre [dayμg/mL] Standard Error NA Adjusted geometric standard error = 1.07	2279.94 Daymicrogram/millilitre [dayμg/mL] Standard Error NA Adjusted geometric standard error = 1.07

Adverse Events

BI 655130 Low Dose SC

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

BI 655130 High Dose SC

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

BI 655130 High Dose IV

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Boehringer Ingelheim, Call Centre

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	BI 655130 Low Dose SC n=12 participants at risk Subject received single low dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose SC n=12 participants at risk Subject received single high dose BI 655130 solution as subcutaneous (SC) injection on day 1.	BI 655130 High Dose IV n=12 participants at risk Subject received single high dose BI 655130 solution as 30 minutes intravenous (IV) infusion on day 1.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Gastrointestinal disorders Nausea	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
General disorders Fatigue	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	25.0% 3/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
General disorders Asthenia	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
General disorders Injection site erythema	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
General disorders Injection site induration	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
General disorders Injection site reaction	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Nervous system disorders Headache	16.7% 2/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	25.0% 3/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	16.7% 2/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Nervous system disorders Paraesthesia	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Cardiac disorders Palpitations	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	16.7% 2/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Injury, poisoning and procedural complications Injury	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Psychiatric disorders Panic attack	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Renal and urinary disorders Dysuria	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Vascular disorders Haematoma	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Infections and infestations Pharyngitis	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	16.7% 2/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	16.7% 2/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Infections and infestations Bronchitis	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Infections and infestations Gastroenteritis	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Infections and infestations Gingivitis	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Infections and infestations Herpes simplex	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Infections and infestations Nasopharyngitis	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Infections and infestations Oral herpes	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Infections and infestations Sialoadenitis	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	33.3% 4/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	33.3% 4/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Gastrointestinal disorders Toothache	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	16.7% 2/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Gastrointestinal disorders Abdominal pain upper	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.
Gastrointestinal disorders Food poisoning	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	8.3% 1/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.	0.00% 0/12 • From first drug administration until end of the treatment, up to 179 days. Treated set (TS): TS includes all subjects who received study drug.