Trial Outcomes & Findings for Phase 1 Study of SL-172154 (SIRPα-Fc-CD40L) in Subjects With Ovarian Cancer (NCT NCT04406623)

NCT ID: NCT04406623

Last Updated: 2025-01-30

Results Overview

Number of participants with treatment emergent adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 27 participants
• Primary outcome timeframe: From Day 1 to 90 days after Last Dose of SL-172154
• Results posted on: 2025-01-30

Participant Flow

Participant milestones

Measure	SL-172154 (0.1 mg/kg) 0.1 mg/kg of SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) 0.3 mg/kg of SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) 1.0 mg/kg of SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) 3.0 mg/kg of SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) 10.0 mg/kg of SL-172154 (Schedule 1)
Overall Study STARTED	3	6	4	9	5
Overall Study COMPLETED	3	6	4	9	5
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 1 Study of SL-172154 (SIRPα-Fc-CD40L) in Subjects With Ovarian Cancer

Baseline characteristics by cohort

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)	Total n=27 Participants Total of all reporting groups
Age, Continuous	72.0 years n=5 Participants	65.0 years n=7 Participants	60.5 years n=5 Participants	68.0 years n=4 Participants	67.0 years n=21 Participants	66.0 years n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants	5 Participants n=21 Participants	27 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	5 Participants n=21 Participants	24 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants	21 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: From Day 1 to 90 days after Last Dose of SL-172154

Number of participants with treatment emergent adverse events

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Safety Profile of SL-172154	3 Participants	6 Participants	4 Participants	9 Participants	5 Participants

PRIMARY outcome

Timeframe: From Day 1 to 90 days after Last Dose of SL-172154

Population: DLT evaluable population

Number of participants with dose limiting toxicities (DLTs)

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=3 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=3 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Maximum Tolerated Dose (MTD) of SL-172154	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Approximately 24 months

Based on review of all data, including safety, tolerability, PK, antitumor activity, and PD effects

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=27 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) 10.0 mg/kg of IV SL-172154 (Schedule 1)
Recommended Phase 2 Dose (RP2D) for SL-172154	3.0 mg/kg	—	—	—	—

SECONDARY outcome

Timeframe: Approximately 24 months

Population: Response Evaluable Population

Number of participants with an objective response per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Objective response includes complete response (disappearance of all target lesions) and partial response (>/= 30% decrease in the sum of the longest diameter of target lesions).

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Assess Preliminary Evidence of Anti-tumor Activity of SL-172154	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 24 months

Population: Immunogenicity Population

Number of participants with positive anti-drug antibody (ADA) titer, sustained ADA response (positive ADA in >/= 2 samples without reverting to negative ADA or positive ADA in the last sample), or persistent ADA response (positive ADA in >/= 2 samples where the first and last samples are >/= 16 weeks apart, or positive ADA in the last sample, or only one sample but < 16 weeks before a negative last sample).

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Immunogenicity to SL-172154 Positive anti-drug antibody titer	1 Participants	4 Participants	2 Participants	3 Participants	3 Participants
Immunogenicity to SL-172154 Sustained ADA response	1 Participants	3 Participants	2 Participants	1 Participants	1 Participants
Immunogenicity to SL-172154 Persistent ADA response	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

Population: PK Population

The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Maximum Serum Concentration (Cmax) of SL-172154 Cycle 1 Day 1	117.68 ng/mL Geometric Coefficient of Variation 31.06	126.33 ng/mL Geometric Coefficient of Variation 89.20	545.03 ng/mL Geometric Coefficient of Variation 406.44	4593.19 ng/mL Geometric Coefficient of Variation 90.34	87509.31 ng/mL Geometric Coefficient of Variation 51.12
Maximum Serum Concentration (Cmax) of SL-172154 Cycle 1 Day 15	59.20 ng/mL Geometric Coefficient of Variation 29.92	136.96 ng/mL Geometric Coefficient of Variation 93.93	1772.77 ng/mL Geometric Coefficient of Variation 111.10	3071.26 ng/mL Geometric Coefficient of Variation 883.11	50484.31 ng/mL Geometric Coefficient of Variation 33.38
Maximum Serum Concentration (Cmax) of SL-172154 Cycle 2 Day 1	72.96 ng/mL Geometric Coefficient of Variation 55.09	82.11 ng/mL Geometric Coefficient of Variation 14.84	1240.25 ng/mL Geometric Coefficient of Variation 72.61	5219.40 ng/mL Geometric Coefficient of Variation 151.02	115536.25 ng/mL Geometric Coefficient of Variation 51.83

SECONDARY outcome

Timeframe: Cycle 1 Day 15 and Cycle 2 Day 1 (each cycle = 28 days)

The Cmin is the minimum observed serum concentration of SL-172154 following at least one dose

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=3 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=8 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=3 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Minimum Serum Concentration (Cmin) of SL-172154 Cycle 1 Day 15	0 ng/mL Geometric Coefficient of Variation NA Coefficient of variation cannot be determined when mean is 0	0 ng/mL Geometric Coefficient of Variation NA Coefficient of variation cannot be determined when mean is 0	0 ng/mL Geometric Coefficient of Variation NA Coefficient of variation cannot be determined when mean is 0	0 ng/mL Geometric Coefficient of Variation NA Coefficient of variation cannot be determined when mean is 0	0 ng/mL Geometric Coefficient of Variation NA Coefficient of variation cannot be determined when mean is 0
Minimum Serum Concentration (Cmin) of SL-172154 Cycle 2 Day 1	0 ng/mL Geometric Coefficient of Variation NA Coefficient of variation cannot be determined when mean is 0	0 ng/mL Geometric Coefficient of Variation NA Coefficient of variation cannot be determined when mean is 0	0 ng/mL Geometric Coefficient of Variation NA Coefficient of variation cannot be determined when mean is 0	0 ng/mL Geometric Coefficient of Variation NA Coefficient of variation cannot be determined when mean is 0	0 ng/mL Geometric Coefficient of Variation NA Coefficient of variation cannot be determined when mean is 0

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

Population: PK Population

The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax) Cycle 1 Day 1	0.5 hours Interval 0.5 to 0.5	0.56 hours Interval 0.5 to 1.6	0.55 hours Interval 0.5 to 2.6	2.53 hours Interval 1.1 to 5.0	3.43 hours Interval 2.0 to 5.0
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax) Cycle 1 Day 15	0.53 hours Interval 0.5 to 0.7	0.54 hours Interval 0.5 to 2.3	0.57 hours Interval 0.5 to 0.6	2.06 hours Interval 1.1 to 2.8	3.6 hours Interval 2.0 to 3.6
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax) Cycle 2 Day 1	0.5 hours Interval 0.5 to 0.5	0.53 hours Interval 0.5 to 1.1	0.55 hours Interval 0.5 to 1.5	2.08 hours Interval 1.0 to 4.1	1.97 hours Interval 1.9 to 2.0

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

Population: PK Population

The AUC is the area under the serum concentration time curve following single and multiple doses of SL-172154. AUC (0-last; from time 0 to the last quantifiable concentration) is reported for C1D1 and AUC (tau; over a dosing interval) is reported for C1D15 and C2D1.

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Area Under the Serum Concentration-time Curve (AUC) Cycle 1 Day 1	NA hours*ng/mL Geometric Coefficient of Variation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	143.54 hours*ng/mL Geometric Coefficient of Variation 7.74	639.40 hours*ng/mL Geometric Coefficient of Variation 18.47	7062.14 hours*ng/mL Geometric Coefficient of Variation 81.59	200095.11 hours*ng/mL Geometric Coefficient of Variation 78.74
Area Under the Serum Concentration-time Curve (AUC) Cycle 1 Day 15	NA hours*ng/mL Geometric Coefficient of Variation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA hours*ng/mL Geometric Coefficient of Variation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA hours*ng/mL Geometric Coefficient of Variation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	13030.1 hours*ng/mL Geometric Coefficient of Variation 27.31	133015.0 hours*ng/mL Geometric Coefficient of Variation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification
Area Under the Serum Concentration-time Curve (AUC) Cycle 2 Day 1	NA hours*ng/mL Geometric Coefficient of Variation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA hours*ng/mL Geometric Coefficient of Variation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA hours*ng/mL Geometric Coefficient of Variation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	6103.60 hours*ng/mL Geometric Coefficient of Variation 130.09	236849.02 hours*ng/mL Geometric Coefficient of Variation 91.90

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

Population: PK Population

Terminal elimination half-life (t1/2) of SL-172154

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Terminal Elimination Half-life (t1/2) Cycle 1 Day 1	NA hours Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	0.50 hours Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	0.37 hours Standard Deviation 0.056	0.75 hours Standard Deviation 0.710	0.86 hours Standard Deviation 0.278
Terminal Elimination Half-life (t1/2) Cycle 1 Day 15	NA hours Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA hours Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA hours Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	0.32 hours Standard Deviation 0.132	0.71 hours Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification
Terminal Elimination Half-life (t1/2) Cycle 2 Day 1	NA hours Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA hours Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA hours Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	0.36 hours Standard Deviation 0.158	1.30 hours Standard Deviation 0.477

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

Population: PK Population

Clearance of SL-172154

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Clearance (CL) Cycle 1 Day 1	NA liters per hour Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	110.64 liters per hour Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	121.22 liters per hour Standard Deviation 46.305	35.73 liters per hour Standard Deviation 25.580	4.13 liters per hour Standard Deviation 2.605
Clearance (CL) Cycle 2 Day 1	NA liters per hour Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA liters per hour Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA liters per hour Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	44.88 liters per hour Standard Deviation 48.958	3.17 liters per hour Standard Deviation 1.637
Clearance (CL) Cycle 1 Day 15	NA liters per hour Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA liters per hour Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA liters per hour Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	15.15 liters per hour Standard Deviation 2.650	4.44 liters per hour Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

Population: PK Population

Volume of distribution of SL-172154

Outcome measures

Measure	SL-172154 (0.1 mg/kg) n=3 Participants 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 Participants 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 Participants 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 Participants 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 Participants 10.0 mg/kg of IV SL-172154 (Schedule 1)
Volume of Distribution Cycle 1 Day 1	NA liters Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	79.83 liters Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	64.28 liters Standard Deviation 28.528	28.46 liters Standard Deviation 17.148	4.84 liters Standard Deviation 2.982
Volume of Distribution Cycle 1 Day 15	NA liters Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA liters Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA liters Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	7.32 liters Standard Deviation 4.187	4.53 liters Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification
Volume of Distribution Cycle 2 Day 1	NA liters Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA liters Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	NA liters Standard Deviation NA Not estimable based on subjects' concentration profiles, including values below the limit of quantification	32.01 liters Standard Deviation 49.282	5.62 liters Standard Deviation 3.337

Adverse Events

SL-172154 (0.1 mg/kg)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

SL-172154 (0.3 mg/kg)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 5 deaths

SL-172154 (1.0 mg/kg)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

SL-172154 (3.0 mg/kg)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 2 deaths

SL-172154 (10.0 mg/kg)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	SL-172154 (0.1 mg/kg) n=3 participants at risk 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 participants at risk 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 participants at risk 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 participants at risk 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 participants at risk 10.0 mg/kg of IV SL-172154 (Schedule 1)
Vascular disorders embolism	33.3% 1/3 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Infections and infestations sepsis	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Number of events 2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Infections and infestations large intestine infection	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Gastrointestinal disorders lower gastrointestinal haemorrhage	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Gastrointestinal disorders small intestinal obstruction	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.

Other adverse events

Measure	SL-172154 (0.1 mg/kg) n=3 participants at risk 0.1 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (0.3 mg/kg) n=6 participants at risk 0.3 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (1.0 mg/kg) n=4 participants at risk 1.0 mg/kg of IV SL-172154 (Schedule 1)	SL-172154 (3.0 mg/kg) n=9 participants at risk 3.0 mg/kg of IV SL-172154 (Schedule 1 or Schedule 2)	SL-172154 (10.0 mg/kg) n=5 participants at risk 10.0 mg/kg of IV SL-172154 (Schedule 1)
Injury, poisoning and procedural complications infusion related reaction	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	50.0% 3/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	50.0% 2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	88.9% 8/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	100.0% 5/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Gastrointestinal disorders nausea	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	50.0% 3/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	75.0% 3/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Gastrointestinal disorders constipation	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	22.2% 2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Gastrointestinal disorders diarrhoea	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	50.0% 2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Gastrointestinal disorders abdominal distension	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Gastrointestinal disorders abdominal pain	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Gastrointestinal disorders vomiting	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Gastrointestinal disorders dyspepsia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Gastrointestinal disorders flatulence	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
General disorders fatigue	100.0% 3/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	66.7% 4/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	22.2% 2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
General disorders chills	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
General disorders pain	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
General disorders oedema peripheral	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Musculoskeletal and connective tissue disorders back pain	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	33.3% 3/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	33.3% 3/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Musculoskeletal and connective tissue disorders muscle spasms	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Musculoskeletal and connective tissue disorders myalgia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Musculoskeletal and connective tissue disorders neck pain	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Metabolism and nutrition disorders decreased appetite	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Metabolism and nutrition disorders dehydration	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Metabolism and nutrition disorders hyperglycaemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	60.0% 3/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Metabolism and nutrition disorders hypoalbuminaemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Metabolism and nutrition disorders hyperkalaemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Metabolism and nutrition disorders hypomagnesaemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Metabolism and nutrition disorders hyponatraemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Metabolism and nutrition disorders hypophosphataemia	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Investigations AST increased	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Investigations ALT increased	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Investigations activated PTT prolonged	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Investigations blood LDH increased	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Nervous system disorders headache	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Skin and subcutaneous tissue disorders pruritis	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	33.3% 2/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Skin and subcutaneous tissue disorders rash maculo-papular	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Vascular disorders hypertension	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Vascular disorders embolism	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Blood and lymphatic system disorders anaemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	22.2% 2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Blood and lymphatic system disorders lymphopenia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Blood and lymphatic system disorders thrombocytopenia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Infections and infestations sepsis	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Infections and infestations urinary tract infection	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	11.1% 1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Respiratory, thoracic and mediastinal disorders dyspnoea	33.3% 1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Respiratory, thoracic and mediastinal disorders cough	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	25.0% 1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Renal and urinary disorders haematuria	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Renal and urinary disorders hydronephrosis	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	16.7% 1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	20.0% 1/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Cardiac disorders sinus tachycardia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.
Hepatobiliary disorders hyperbilirubinaemia	0.00% 0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	0.00% 0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.	40.0% 2/5 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 10.5 weeks.

Additional Information

VP, Clinical Operations

Shattuck Labs

Phone: 919-864-2700

Email: clinicaltrials@shattucklabs.com

Results disclosure agreements

• Principal investigator is a sponsor employee Site agrees not to publish any Study Results or data before the publication of results from the Overall Study. After Sponsor has published the results of the Overall Study, Site may publish or present results generated at Site. If Sponsor has not published results of the Overall Study within 18 months of data base lock, Site may publish the results of the Study that were generated at Site. Site agrees to first submit to Sponsor the proposed publication at least 30 days prior to the submission.
• Publication restrictions are in place

Restriction type: OTHER