Trial Outcomes & Findings for Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting (NCT NCT04396106)

Last Updated: 2023-03-09

Results Overview

Progressive respiratory insufficiency defined as a ≥ 2-tier increase in respiratory support methods required to maintain satisfactory oxygenation (SpO2 ≥ 93%), using the 6-tier hierarchical scale of respiratory support methods, within the 14-day study period. Level 1:Normal oxygenation on room air (SpO2 ≥93), no need for supplemental O2 Level 2:Persistent hypoxemia on room air (SpO2 \<93) with requirement for low-level supplemental O2 by nasal cannula/mask (up to 2L/min) to maintain SpO2 ≥93 Level 3:Requirement for higher levels of passive supplemental O2 by nasal cannula or mask (≥2 L/min) to maintain SpO2 ≥93 Level 4:Requirement for oxygenation by positive-pressure devices Level 5:Required invasive respiratory support (intubated mechanical ventilation or ECMO) Level 6:Death

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

Day 14

Results posted on

2023-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	AT-527 - 550 mg BID Part A AT-527: One 550 mg tablet of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 550 mg BID Part A Placebo: One placebo tablet administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 1100 mg BID Part B Placebo: Two placebo tablets administered every \~12 hours (twice a day) for a total of 5 days
Overall Study STARTED	41	40	2
Overall Study COMPLETED	37	37	1
Overall Study NOT COMPLETED	4	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AT-527 - 550 mg BID n=41 Participants Part A AT-527: One 550 mg tablet of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 550 mg BID n=40 Participants Part A Placebo: One placebo tablet administered every \~12 hours (twice a day) for a total of 5 days	AT-527 - 1100 mg BID Part B AT-527: Two 550 mg tablets of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 1100 mg BID n=2 Participants Part B Placebo: Two placebo tablets administered every \~12 hours (twice a day) for a total of 5 days	Total n=83 Participants Total of all reporting groups
Age, Continuous	54.3 years STANDARD_DEVIATION 11.07 • n=5 Participants	57.4 years STANDARD_DEVIATION 8.33 • n=7 Participants	—	33.5 years STANDARD_DEVIATION 20.5 • n=4 Participants	55.8 years STANDARD_DEVIATION 9.88 • n=21 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	25 Participants n=7 Participants	—	2 Participants n=4 Participants	46 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	—	0 Participants n=4 Participants	37 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	—	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	—	0 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	32 Participants n=7 Participants	—	2 Participants n=4 Participants	63 Participants n=21 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	—	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 14

Population: Intent-to-treat

Outcome measures

Outcome measures
Measure	AT-527 - 550 mg BID n=41 Participants Part A AT-527: One 550 mg tablet of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 550 mg BID n=40 Participants Part A Placebo: One placebo tablet administered every \~12 hours (twice a day) for a total of 5 days	AT-527 - 1100 mg BID Part B AT-527: Two 550 mg tablets of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 1100 mg BID n=2 Participants Part B Placebo: Two placebo tablets administered every \~12 hours (twice a day) for a total of 5 days
Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before Day 14.	3 Participants	4 Participants	—	0 Participants

SECONDARY outcome

Timeframe: Through Day 14

Population: The modified intent-to-treat (mITT) analysis set included subjects who were randomized and treated and who had a positive SARS-CoV2 test result at baseline.

Change in the viral load as measured by swab of the upper part of the pharynx.

Outcome measures

Outcome measures
Measure	AT-527 - 550 mg BID n=35 Participants Part A AT-527: One 550 mg tablet of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 550 mg BID n=36 Participants Part A Placebo: One placebo tablet administered every \~12 hours (twice a day) for a total of 5 days	AT-527 - 1100 mg BID Part B AT-527: Two 550 mg tablets of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 1100 mg BID n=2 Participants Part B Placebo: Two placebo tablets administered every \~12 hours (twice a day) for a total of 5 days
Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab Change from baseline to Day 5	-1.00 log10 copies/mL Standard Deviation 1.316	-0.80 log10 copies/mL Standard Deviation 1.853	—	-2.51 log10 copies/mL Standard Deviation 0.66
Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab Change from baseline to Day 2	-0.55 log10 copies/mL Standard Deviation 1.175	-0.02 log10 copies/mL Standard Deviation 1.838	—	-1.37 log10 copies/mL Standard Deviation 1.57
Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab Change from baseline to Day 8	-1.64 log10 copies/mL Standard Deviation 1.534	-1.38 log10 copies/mL Standard Deviation 1.281	—	-3.78 log10 copies/mL Standard Deviation 1.39
Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab Change from baseline to Day 10	-1.72 log10 copies/mL Standard Deviation 1.734	-2.26 log10 copies/mL Standard Deviation 1.452	—	-4.78 log10 copies/mL Standard Deviation 2.13
Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab Change from baseline to Day 12	-2.13 log10 copies/mL Standard Deviation 2.065	-2.08 log10 copies/mL Standard Deviation 1.584	—	-4.78 log10 copies/mL Standard Deviation 2.13
Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab Change from baseline to Day 14	-2.61 log10 copies/mL Standard Deviation 1.873	-2.26 log10 copies/mL Standard Deviation 1.747	—	-4.13 log10 copies/mL Standard Deviation 1.21

Adverse Events

AT-527 - 550 mg BID

Serious events: 5 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo for 550 mg BID

Serious events: 3 serious events

Other events: 23 other events

Deaths: 2 deaths

AT-527 - 1100 mg BID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo for 1100 mg BID

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	AT-527 - 550 mg BID n=40 participants at risk Part A AT-527: One 550 mg tablet of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 550 mg BID n=40 participants at risk Part A Placebo: One placebo tablet administered every \~12 hours (twice a day) for a total of 5 days	AT-527 - 1100 mg BID Part B AT-527: Two 550 mg tablets of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 1100 mg BID n=2 participants at risk Part B Placebo: Two placebo tablets administered every \~12 hours (twice a day) for a total of 5 days
Investigations Oxygen saturation decreased	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Infections and infestations Abdominal abscess	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Infections and infestations COVID-19 pneumonia	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Vascular disorders Haemodynamic instability	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Infections and infestations Pneumonia	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	50.0% 1/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.

Other adverse events

Additional Information

Atea Clinical Trials

Atea Pharmaceuticals, Inc.

Phone: 1-857-284-8891

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigator may publish or present results pertaining to the PI's activities after the first publication of the multicentre clinical trial results, or 18 months after the clinical study database lock. Any such publications must be submitted for review by Sponsor before submission. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	AT-527 - 550 mg BID n=40 participants at risk Part A AT-527: One 550 mg tablet of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 550 mg BID n=40 participants at risk Part A Placebo: One placebo tablet administered every \~12 hours (twice a day) for a total of 5 days	AT-527 - 1100 mg BID Part B AT-527: Two 550 mg tablets of AT-527 administered every \~12 hours (twice a day) for a total of 5 days	Placebo for 1100 mg BID n=2 participants at risk Part B Placebo: Two placebo tablets administered every \~12 hours (twice a day) for a total of 5 days
Investigations Blood triglycerides increased	15.0% 6/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	15.0% 6/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Investigations Alanine aminotransferase increased	7.5% 3/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	15.0% 6/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Investigations Blood cholesterol increased	12.5% 5/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Investigations Aspartate aminotransferase increased	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	7.5% 3/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Investigations Oxygen saturation decreased	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Investigations Lipase increased	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Gastrointestinal disorders Diarrhoea	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	7.5% 3/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Gastrointestinal disorders Enterocolitis	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Gastrointestinal disorders Flatulence	2.5% 1/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
General disorders Injection site haemorrhage	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Cardiac disorders Sinus tachycardia	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	50.0% 1/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Hepatobiliary disorders Hepatitis	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	50.0% 1/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	50.0% 1/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	50.0% 1/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	50.0% 1/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.
Infections and infestations Pneumonia	0.00% 0/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	5.0% 2/40 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	— 0/0 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.	0.00% 0/2 • 28 days Treatment emergent adverse events (TEAEs) were defined as any adverse event that started or worsened in severity on or after the first dose of study drug.