Trial Outcomes & Findings for A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 (COVID-19) (NCT NCT04481685)

Results Overview

Proportion of responders on Day 14 defined as all subjects who are alive, free of respiratory failure (do not require supplemental oxygen) and do not experience negative intercurrent events by Day 14 of the trial will be considered responders, as assessed by participant medical records.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Study day 14

Results posted on

2025-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	ATI-450 Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 (COVID-19)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.	Total n=20 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
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	64 years n=5 Participants	63 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Study day 14

Proportion of responders on Day 14 defined as all subjects who are alive, free of respiratory failure (do not require supplemental oxygen) and do not experience negative intercurrent events by Day 14 of the trial will be considered responders, as assessed by participant medical records.

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Respiratory Failure-free Survival in Participants With Moderate-severe COVID-19 Who Are Treated With ATI-450	50 percentage of total patients Interval 22.2 to 77.8	60 percentage of total patients Interval 30.4 to 85.0

SECONDARY outcome

Timeframe: Baseline, Day 7, Day 14, Day 28 and follow-up up to 9 months

Using World Health Organization (WHO) COVID-19 Ordinal scale measuring: Participants were assessed on a 7-point categorical scale, and change in scores between timepoints is reported. This scale measures illness severity over time and has a range of 0-7. * 0- Uninfected: No clinical or virological evidence of infection. * 1- Ambulatory: No limitation of activities. * 2- Ambulatory: Limitation of activities. * 3- Hospitalized, mild disease: Hospitalized, no oxygen. * 4- Hospitalized, mild disease: Oxygen by mask or nasal prongs. * 5- Hospitalized, severe disease: Non- invasive ventilation or high- flow oxygen. * 6- Hospitalized, severe disease: Intubation and mechanical ventilation. * 7- Hospitalized, severe disease: Ventilation + organ support; pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO).

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Change in 7 Point-ordinal Scale Baseline to Day 7	0 score on a scale Standard Deviation 0.4714	0 score on a scale Standard Deviation 0.4714
Change in 7 Point-ordinal Scale baseline to EoT	0.7 score on a scale Standard Deviation 1.2517	0.1 score on a scale Standard Deviation 1.3703
Change in 7 Point-ordinal Scale baseline to Day 14	1.7 score on a scale Standard Deviation 1.5670	1.9 score on a scale Standard Deviation 1.7920
Change in 7 Point-ordinal Scale baseline to Day 28	2.7 score on a scale Standard Deviation 1.1738	2.2 score on a scale Standard Deviation 0.9189

SECONDARY outcome

Timeframe: Baseline and continuous throughout hospitalization up to 14 days

Derived from medical record

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Number of Participants With a Need for Advanced Respiratory Care	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and through day 60

Noted in participant medical record

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
All-cause Mortality	1 participants	1 participants

SECONDARY outcome

Timeframe: Up to Day 60

Number of adverse events (AEs), as assessed by CTCAE v5.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL (Activities of Daily Living). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Treatment-emergent Adverse Events Any Grade	14 adverse events	6 adverse events
Treatment-emergent Adverse Events Grade 1-2	12 adverse events	6 adverse events
Treatment-emergent Adverse Events Grade 3	2 adverse events	0 adverse events
Treatment-emergent Adverse Events Grade 4	0 adverse events	0 adverse events
Treatment-emergent Adverse Events Grade 5	0 adverse events	0 adverse events

SECONDARY outcome

Timeframe: Up to Day 60

Population: Report of any treatment-emergent Serious adverse events (TeSAE)

Number of serious adverse events (SAEs), as assessed by CTCAE v5.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Treatment-emergent Serious Adverse Events Any Grade	2 serious adverse events	2 serious adverse events
Treatment-emergent Serious Adverse Events Grade 1 or 2	0 serious adverse events	1 serious adverse events
Treatment-emergent Serious Adverse Events Grade 4	0 serious adverse events	0 serious adverse events
Treatment-emergent Serious Adverse Events Grade 3	1 serious adverse events	0 serious adverse events
Treatment-emergent Serious Adverse Events Grade 5	1 serious adverse events	1 serious adverse events

SECONDARY outcome

Timeframe: Baseline through day 14 or at discharge <day 14

Standard daily temperature measurement and obtained from participant medical record

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Number of Participants With Normalization of Fever for 24 Hours	9 participants	9 participants

SECONDARY outcome

Timeframe: Continuous throughout hospitalization up to 14 days

Noted in participant medical record

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Number of Participants Who Develop New Bacterial Infection	0 participants	0 participants

SECONDARY outcome

Timeframe: Continuous throughout hospitalization up to 14 days

Noted in participant medical record

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Number of Participants Who Develop New Fungal Infection	1 participants	0 participants

SECONDARY outcome

Timeframe: From day 1 though day 14 or at discharge <day 14

Noted in participant medical record

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Number of Adult Respiratory Distress Syndrome (ARDS2)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to End of Treatment, or Day 14

Population: baseline vs EoT

Plasma was assayed by Confluence Discovery Technologies using the MesoScale Discovery Platform from biobanked samples stored from the University of Kansas Medical Center (KUMC) Biobanking and Biomarker Validation (BBV) Core, expressed in pg/mL. Change in biomarker was reported as a percent based on (EOT or D14)/baseline x100%.

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Change in Serum Cytokine Interleukin (IL)-6	34.8 percentage of baseline Interval 30.6 to 41.3	137.6 percentage of baseline Interval 16.5 to 187.0

SECONDARY outcome

Timeframe: Baseline to End of Treatment, or Day 14

Population: baseline vs EoT

Plasma was assayed by Confluence Discovery Technologies using the MesoScale Discovery Platform from biobanked samples stored from the University of Kansas Medical Center (KUMC) Biobanking and Biomarker Validation (BBV) Core, expressed in pg/mL. Change in biomarker was reported as a percent based on (EOT or D14)/baseline x100%.

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Change in Serum Cytokine IL-8	40.1 percentage of baseline Interval 23.4 to 74.1	82.3 percentage of baseline Interval 69.1 to 145.5

SECONDARY outcome

Timeframe: Baseline to End of Treatment, or Day 14

Population: Baseline vs EoT - this could not be measured because analyte could not be detected

Plasma was assayed by Confluence Discovery Technologies using the MesoScale Discovery Platform from biobanked samples stored from the University of Kansas Medical Center (KUMC) Biobanking and Biomarker Validation (BBV) Core, expressed in pg/mL. Change in biomarker was reported as a percent based on (EOT or D14)/baseline x100%.

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Change in Serum Cytokines IL-1β	NA percentage of baseline Standard Deviation NA Baseline vs EoT - this could not be measured because analyte could not be detected	NA percentage of baseline Standard Deviation NA Baseline vs EoT - this could not be measured because analyte could not be detected

SECONDARY outcome

Timeframe: Baseline to End of Treatment, or Day 14

Population: baseline vs EoT

Plasma was assayed by Confluence Discovery Technologies using the MesoScale Discovery Platform from biobanked samples stored from the University of Kansas Medical Center (KUMC) Biobanking and Biomarker Validation (BBV) Core, expressed in pg/mL. Change in biomarker was reported as a percent based on (EOT or D14)/baseline x100%.

Outcome measures

Outcome measures
Measure	ATI-450 n=10 Participants Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 Participants Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Change in Serum Cytokine Tumor Necrosis Factor (TNF-α)	56.6 percentage of baseline Interval 32.1 to 119.5	104.1 percentage of baseline Interval 85.4 to 134.7

Adverse Events

ATI-450

Serious events: 2 serious events

Other events: 7 other events

Deaths: 1 deaths

Placebo

Serious events: 2 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	ATI-450 n=10 participants at risk Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 participants at risk Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Respiratory, thoracic and mediastinal disorders multi-organ failure	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Respiratory, thoracic and mediastinal disorders hypoxia	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Cardiac disorders non-cardiac chest pain	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.

Other adverse events

Additional Information

Gregory Gan, MD PhD

University of Kansas Medical Center

Phone: 913 588 5881

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	ATI-450 n=10 participants at risk Treated with 50 mg dose of ATI-450, orally, twice daily for 14 days ATI-450: 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.	Placebo n=10 participants at risk Treated with matched placebo, orally, twice daily for 14 days Placebo: Placebo pill will be taken twice daily preferably spaced 12 hours apart.
Vascular disorders superficial thrombophlebitis	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Cardiac disorders cardiac troponin	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Blood and lymphatic system disorders lymphocele	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Renal and urinary disorders hematuria	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Musculoskeletal and connective tissue disorders gout	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Endocrine disorders hyperglycemia	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Musculoskeletal and connective tissue disorders arthritis	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Cardiac disorders sinus bradycardia	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Hepatobiliary disorders GGT increased	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Hepatobiliary disorders aspartate aminotransferase increase	20.0% 2/10 • Number of events 2 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Hepatobiliary disorders alanine aminotransferase increase	20.0% 2/10 • Number of events 2 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Renal and urinary disorders creatinine increased	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Skin and subcutaneous tissue disorders skin hyperpigmentation	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Musculoskeletal and connective tissue disorders extremity pain	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Cardiac disorders sinus tachycardia	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Gastrointestinal disorders gastrointestinal pain	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Cardiac disorders non-cardiac chest pain	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Respiratory, thoracic and mediastinal disorders hypoxia	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.
Infections and infestations thrush	10.0% 1/10 • Number of events 1 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.	0.00% 0/10 • Adverse events were collected from initiation of study treatment and continues until the Day 60 safety follow-up. Per protocol, medical history adverse events are recorded and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Serious adverse event and adverse event monitoring begins after initiation of study treatment and continues until the Day 60 safety follow-up. This Day 60 follow-up check and will be done by phone.