Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects (NCT NCT04909450)

Last Updated: 2026-05-13

Results Overview

Percentage of subjects achieving complete corneal healing in study eye as assessed by the Central Reading Center (CRC). Complete corneal healing was defined as absence of corneal staining in the area of the defect/ulcer (i.e., 0 mm lesion) at Week 8 and the absence of corneal staining in the area of the defect/ulcer (i.e., 0 mm lesion) at Week 10.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

131 participants

Primary outcome timeframe

Week 8 through Week 10

Results posted on

2026-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	CSB-001 Investigational Treatment Arm One drop CSB-001 four times daily for 8 weeks in the study eye CSB-001 Ophthalmic Solution 0.1%: CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)	Vehicle Control Arm One drop matching vehicle four times daily for 8 weeks in the study eye Vehicle Control: Matching vehicle control without the drug substance
Overall Study STARTED	69	62
Overall Study Received CSB-001 in Uncontrolled Investigational Treatment Arm	0	25
Overall Study COMPLETED	62	56
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CSB-001 Investigational Treatment Arm n=67 Participants One drop CSB-001 four times daily for 8 weeks in the study eye CSB-001 Ophthalmic Solution 0.1%: CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)	Vehicle Control Arm n=62 Participants One drop matching vehicle four times daily for 8 weeks in the study eye Vehicle Control: Matching vehicle control without the drug substance	Total n=129 Participants Total of all reporting groups
Age, Continuous	66.0 years n=1512 Participants	72.0 years n=504 Participants	70.0 years n=2016 Participants
Age, Customized Age group, n (%) · < 60	23 Participants n=1512 Participants	13 Participants n=504 Participants	36 Participants n=2016 Participants
Age, Customized Age group, n (%) · ≥ 60	44 Participants n=1512 Participants	49 Participants n=504 Participants	93 Participants n=2016 Participants
Sex: Female, Male Female	38 Participants n=1512 Participants	34 Participants n=504 Participants	72 Participants n=2016 Participants
Sex: Female, Male Male	29 Participants n=1512 Participants	28 Participants n=504 Participants	57 Participants n=2016 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=1512 Participants	13 Participants n=504 Participants	24 Participants n=2016 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=1512 Participants	49 Participants n=504 Participants	105 Participants n=2016 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=1512 Participants	1 Participants n=504 Participants	2 Participants n=2016 Participants
Race (NIH/OMB) Asian	2 Participants n=1512 Participants	2 Participants n=504 Participants	4 Participants n=2016 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=1512 Participants	1 Participants n=504 Participants	2 Participants n=2016 Participants
Race (NIH/OMB) Black or African American	3 Participants n=1512 Participants	2 Participants n=504 Participants	5 Participants n=2016 Participants
Race (NIH/OMB) White	56 Participants n=1512 Participants	55 Participants n=504 Participants	111 Participants n=2016 Participants
Race (NIH/OMB) More than one race	2 Participants n=1512 Participants	1 Participants n=504 Participants	3 Participants n=2016 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=1512 Participants	0 Participants n=504 Participants	2 Participants n=2016 Participants
Current Neurotrophic Keratitis (NK) Stage Stage 2	49 Participants n=1512 Participants	41 Participants n=504 Participants	90 Participants n=2016 Participants
Current Neurotrophic Keratitis (NK) Stage Stage 3	18 Participants n=1512 Participants	21 Participants n=504 Participants	39 Participants n=2016 Participants
Time since Current NK stage Diagnosis	2.50 months n=1512 Participants	2.45 months n=504 Participants	2.50 months n=2016 Participants

PRIMARY outcome

Timeframe: Week 8 through Week 10

Population: The full analysis set (FAS) includes all subjects who were randomized and confirmed by the CRC with stage 2 or 3 neurotrophic keratitis at the screening visit.

Outcome measures

Outcome measures
Measure	CSB-001 Investigational Treatment Arm n=54 Participants One drop CSB-001 four times daily for 8 weeks in the study eye CSB-001 Ophthalmic Solution 0.1%: CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)	Vehicle Control Arm n=51 Participants One drop matching vehicle four times daily for 8 weeks in the study eye Vehicle Control: Matching vehicle control without the drug substance
Efficacy as Assessed by Complete Corneal Healing	21 Participants	16 Participants

PRIMARY outcome

Timeframe: Screening (Day 0) through Week 10

Population: The safety analysis set (SAS) is defined as all subjects who were randomized.

Number of participants with ocular and systemic adverse events

Outcome measures

Outcome measures
Measure	CSB-001 Investigational Treatment Arm n=69 Participants One drop CSB-001 four times daily for 8 weeks in the study eye CSB-001 Ophthalmic Solution 0.1%: CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)	Vehicle Control Arm n=62 Participants One drop matching vehicle four times daily for 8 weeks in the study eye Vehicle Control: Matching vehicle control without the drug substance
Safety as Assessed by Adverse Event Reporting Any systemic TEAEs	10 Participants	23 Participants
Safety as Assessed by Adverse Event Reporting Any ocular TEAEs (study eye)	32 Participants	35 Participants

Adverse Events

CSB-001 Uncontrolled Investigational Treatment Arm

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Vehicle Control Arm

Serious events: 7 serious events

Other events: 35 other events

Deaths: 1 deaths

CSB-001 Investigational Treatment Arm

Serious events: 8 serious events

Other events: 18 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CSB-001 Uncontrolled Investigational Treatment Arm n=25 participants at risk One drop CSB-001 four times daily for 8 weeks in the study eye CSB-001 Ophthalmic Solution 0.1%: CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)	Vehicle Control Arm n=62 participants at risk One drop matching vehicle four times daily for 8 weeks in the study eye Vehicle Control: Matching vehicle control without the drug substance	CSB-001 Investigational Treatment Arm n=69 participants at risk One drop CSB-001 four times daily for 8 weeks in the study eye CSB-001 Ophthalmic Solution 0.1%: CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Eye disorders Corneal oedema	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	8.1% 5/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Eye disorders Neurotrophic keratopathy	4.0% 1/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	4.8% 3/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	10.1% 7/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Eye disorders Eye irritation	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	8.1% 5/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	2.9% 2/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Eye disorders Ocular hyperaemia	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	6.5% 4/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	4.3% 3/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Eye disorders Visual acuity reduced	12.0% 3/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	6.5% 4/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	4.3% 3/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Eye disorders Conjunctival hyperaemia	4.0% 1/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	6.5% 4/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
General disorders Instillation site pain	4.0% 1/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	8.1% 5/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Infections and infestations COVID-19	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	8.1% 5/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Eye disorders Eye pain	8.0% 2/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.

Additional Information

Tomi Luan, OD, PhD

Claris Biotherapeutics, Inc.

Phone: 619-504-0309

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CSB-001 Uncontrolled Investigational Treatment Arm n=25 participants at risk One drop CSB-001 four times daily for 8 weeks in the study eye CSB-001 Ophthalmic Solution 0.1%: CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)	Vehicle Control Arm n=62 participants at risk One drop matching vehicle four times daily for 8 weeks in the study eye Vehicle Control: Matching vehicle control without the drug substance	CSB-001 Investigational Treatment Arm n=69 participants at risk One drop CSB-001 four times daily for 8 weeks in the study eye CSB-001 Ophthalmic Solution 0.1%: CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Eye disorders Neurotrophic keratopathy	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.6% 1/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	2.9% 2/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Eye disorders Retinal detachment	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Cardiac disorders Myocardial infarction	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Infections and infestations Cellulitis	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.6% 1/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Infections and infestations Osteomyelitis	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.6% 1/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Infections and infestations Pneumonia pseudomonal	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.6% 1/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Infections and infestations Urosepsis	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Injury, poisoning and procedural complications Fall	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.6% 1/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.6% 1/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Investigations Haemoglobin decreased	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.6% 1/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.6% 1/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Nervous system disorders Cerebrovascular accident	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.6% 1/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.6% 1/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	1.4% 1/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Blood and lymphatic system disorders Anemia	4.0% 1/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Metabolism and nutrition disorders Hyponatremia	4.0% 1/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.
Investigations Low hemoglobin	4.0% 1/25 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/62 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.	0.00% 0/69 • Controlled Treatment Phase: 10 weeks and Uncontrolled Treatment Phase: 10 weeks for a total of 20 weeks Treatment-emergent AEs (TEAEs) were those that were experienced on or after the day of first dose in the study.