Trial Outcomes & Findings for A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers. (NCT NCT01955564)

NCT ID: NCT01955564

Last Updated: 2017-06-20

Results Overview

Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 54 participants
• Primary outcome timeframe: Day -1(pre-dose) through Day 8 (Discharge)
• Results posted on: 2017-06-20

Participant Flow

A total of 54 healthy males, who were between the age of 18-45 years old, with a minimum body weight of 45 kg and body mass index of more than or equal to 30, were recruited and observed in the period from 23rd of July 2013 till 19th of September 2014 in this study conducted at a single site in the US.

Participant milestones

Measure	Placebo Placebo, single dose	Cohort 1 NW-3509a - 1mg, single dose	Cohort 2 NW-3509a 2mg, single dose	Cohort 3 NW-3509a 5mg, single dose	Cohort 4 NW-3509a 10 mg, single dose	Cohort 5 NW-3509a 20 mg, single dose	Cohort 6 NW-3509a 30 mg, single dose
Overall Study STARTED	18	6	6	6	6	6	6
Overall Study COMPLETED	18	6	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.

Baseline characteristics by cohort

Measure	Placebo n=18 Participants placebo: single dose	Cohort 1 n=6 Participants NW-3509a - 1mg NW-3509a: single dose	Cohort 2 n=6 Participants NW-3509a 2mg NW-3509a: single dose	Cohort 3 n=6 Participants NW-3509a 5mg NW-3509a: single dose	Cohort 4 n=6 Participants NW-3509a 10 mg NW-3509a: single dose	Cohort 5 n=6 Participants NW-3509a 20 mg NW-3509a: single dose	Cohort 6 n=6 Participants NW-3509a 30 mg NW-3509a: single dose	Total n=54 Participants Total of all reporting groups
Age, Customized 18-45	31.27 years STANDARD_DEVIATION 7.71 • n=5 Participants	28.33 years STANDARD_DEVIATION 6.31 • n=7 Participants	23.83 years STANDARD_DEVIATION 6.91 • n=5 Participants	30.33 years STANDARD_DEVIATION 8.12 • n=4 Participants	34.83 years STANDARD_DEVIATION 5.85 • n=21 Participants	29.50 years STANDARD_DEVIATION 3.51 • n=8 Participants	24.33 years STANDARD_DEVIATION 3.56 • n=8 Participants	28.92 years STANDARD_DEVIATION 3.88 • n=24 Participants
Sex: Female, Male Female	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	0 Participants n=8 Participants	0 Participants n=24 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	6 Participants n=8 Participants	54 Participants n=24 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants	2 participants n=8 Participants	0 participants n=8 Participants	8 participants n=24 Participants
Race/Ethnicity, Customized African American	7 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	3 participants n=21 Participants	4 participants n=8 Participants	1 participants n=8 Participants	25 participants n=24 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	0 participants n=8 Participants	1 participants n=8 Participants	5 participants n=24 Participants
Race/Ethnicity, Customized Caucasian	8 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	3 participants n=8 Participants	15 participants n=24 Participants
Race/Ethnicity, Customized Native American	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	1 participants n=8 Participants	1 participants n=24 Participants
Region of Enrollment United States	18 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	6 participants n=21 Participants	6 participants n=8 Participants	6 participants n=8 Participants	54 participants n=24 Participants

PRIMARY outcome

Timeframe: Day -1(pre-dose) through Day 8 (Discharge)

Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.

Outcome measures

Measure	Placebo n=18 Participants Placebo, single dose	Cohort 1 n=6 Participants NW-3509a - 1mg, single dose	Cohort 2 n=6 Participants NW-3509a 2mg, single dose	Cohort 3 n=6 Participants NW-3509a 5mg, single dose	Cohort 4 n=6 Participants NW-3509a 10 mg, single dose	Cohort 5 n=6 Participants NW-3509a 20 mg, single dose	Cohort 6 n=6 Participants NW-3509a 30 mg, single dose
Physical Examination Shift Table	1 Participants abnormal at end of study	1 Participants abnormal at end of study	0 Participants abnormal at end of study	0 Participants abnormal at end of study	1 Participants abnormal at end of study	1 Participants abnormal at end of study	0 Participants abnormal at end of study

SECONDARY outcome

Timeframe: Baseline up to 32 hours post-dose

Plasma concentration data, derived PK parameters, and urine data are summarized as maximum plasma concentration (Cmax).

The plasma concentrations of NW-3509A in the samples taken from the subjects receiving placebo were below the limit of quantification (<1.00 ng/mL) in all cases (n=18).

Outcome measures

Measure	Placebo n=6 Participants Placebo, single dose	Cohort 1 n=6 Participants NW-3509a - 1mg, single dose	Cohort 2 n=6 Participants NW-3509a 2mg, single dose	Cohort 3 n=6 Participants NW-3509a 5mg, single dose	Cohort 4 n=6 Participants NW-3509a 10 mg, single dose	Cohort 5 n=6 Participants NW-3509a 20 mg, single dose	Cohort 6 NW-3509a 30 mg, single dose
Maximum Plasma Concentration of NW-3509A at Doses Tested	2.08 ng/mL Standard Deviation 1.20	3.49 ng/mL Standard Deviation 1.98	14.2 ng/mL Standard Deviation 7.2	22.5 ng/mL Standard Deviation 16.4	36.4 ng/mL Standard Deviation 30.1	93.3 ng/mL Standard Deviation 18.0	—

SECONDARY outcome

Timeframe: Baseline up to 32 hours post-dose

Plasma concentration data, derived PK parameters, and urine data were summarized as total drug exposure over time (AUC0-t).

The plasma concentrations of NW-3509A in the samples taken from the subjects receiving placebo were below the limit of quantification (<1.00 ng/mL) in all cases (n=18).

Outcome measures

Measure	Placebo n=6 Participants Placebo, single dose	Cohort 1 n=6 Participants NW-3509a - 1mg, single dose	Cohort 2 n=6 Participants NW-3509a 2mg, single dose	Cohort 3 n=6 Participants NW-3509a 5mg, single dose	Cohort 4 n=6 Participants NW-3509a 10 mg, single dose	Cohort 5 n=6 Participants NW-3509a 20 mg, single dose	Cohort 6 NW-3509a 30 mg, single dose
Total Drug Exposure Over Time (AUC0-t) of NW-3509A at Doses Tested	6.71 ng.h/mL Standard Deviation 9.24	13.4 ng.h/mL Standard Deviation 11.2	56.7 ng.h/mL Standard Deviation 30.5	101 ng.h/mL Standard Deviation 86	166 ng.h/mL Standard Deviation 175	350 ng.h/mL Standard Deviation 34	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 4

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 5

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 6

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=18 participants at risk placebo, single dose	Cohort 1 n=6 participants at risk NW-3509a 1mg, single dose	Cohort 2 n=6 participants at risk NW-3509a 2mg, single dose	Cohort 3 n=6 participants at risk NW-3509a 5mg, single dose	Cohort 4 n=6 participants at risk NW-3509a 10 mg, single dose	Cohort 5 n=6 participants at risk NW-3509a 20 mg, single dose	Cohort 6 n=6 participants at risk NW-3509a 30 mg, single dose
Cardiac disorders Postural Orthostatic and tachycardia syndrome	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	33.3% 2/6 • Number of events 2 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Gastrointestinal disorders Constipation	5.6% 1/18 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Gastrointestinal disorders Nausea	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Gastrointestinal disorders Toothache	5.6% 1/18 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
General disorders Feeling hot	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Injury, poisoning and procedural complications Confusion	5.6% 1/18 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	33.3% 2/6 • Number of events 2 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Skin and subcutaneous tissue disorders Excoriation	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Skin and subcutaneous tissue disorders Thermal burn	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Investigations Blood creatine phosphate kinase	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Nervous system disorders Coordination abnormal	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Nervous system disorders Dizziness	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Nervous system disorders Headache	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
General disorders Presyncope	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
General disorders Somnolence	11.1% 2/18 • Number of events 2 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Nervous system disorders Somnolence	11.1% 2/18 • Number of events 2 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.6% 1/18 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Skin and subcutaneous tissue disorders Rash Papular	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.
Vascular disorders Orthostatic hypotension	0.00% 0/18 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	16.7% 1/6 • Number of events 1 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.	0.00% 0/6 • Adverse Event evaluations were performed during the screening period, at baseline, Day 2 and Day 8. In addition, all subjects were followed up for 30 days after their dose of study medication for the occurrence of any SAEs Systematic assessment by standard questionnaires, regular investigator assessment, and regular laboratory testing at each visit.

Additional Information

Dr. Ravi Anand

Newron Pharmaceuticals S.p.A.

Phone: +39 026103461

Email: ravi@anand.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place