Trial Outcomes & Findings for Evaluation of FDY-5301 in Major Trauma Patients in ICU (NCT NCT04430283)

Last Updated: 2023-06-13

Results Overview

Chelsea Critical Care Physical Assessment Tool (CPAx) total score at Day 10, or hospital discharge, whichever occurs first. The Chelsea Critical Care Physical Assessment Tool components will be graded on a 6-point scale from dependent to independent (0 to 5). The individual values will be collated giving a total score out of 50. A higher score indicates a better outcome.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Day 10 or hospital discharge, whichever occurs first.

Results posted on

2023-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	FDY-5301 Low Dose 1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	FDY-5301 High Dose 2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	Placebo Placebo will be administered intravenously once daily for up to 7 days.
Overall Study STARTED	2	2	4
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	2	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of FDY-5301 in Major Trauma Patients in ICU

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FDY-5301 Low Dose n=2 Participants 1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	FDY-5301 High Dose n=2 Participants 2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	Placebo n=4 Participants Placebo will be administered intravenously once daily for up to 7 days.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	34 years n=5 Participants	32.5 years n=7 Participants	25.25 years n=5 Participants	29.25 years n=4 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
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	8 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 10 or hospital discharge, whichever occurs first.

Population: Overall number of participants analyzed for CPAx data includes only those who have Day 10 CPAx scores. The small number of subjects enrolled in each of the groups preclude interpretation of the CPAx data.

Outcome measures

Outcome measures
Measure	FDY-5301 Low Dose n=1 Participants 1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	FDY-5301 High Dose n=2 Participants 2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	Placebo n=3 Participants Placebo will be administered intravenously once daily for up to 7 days.
Chelsea Critical Care Physical Assessment Tool	9 Score on a scale Interval 9.0 to	31.5 Score on a scale Interval 28.0 to 35.0	11 Score on a scale Interval 10.0 to 12.0

PRIMARY outcome

Timeframe: Day 28 or hospital discharge, whichever occurs first.

Population: The small number of subjects enrolled in each of the groups preclude interpretation of the organ dysfunction total TTR data.

Organ dysfunction total time to recovery (TTR) until Day 28

Outcome measures

Outcome measures
Measure	FDY-5301 Low Dose n=2 Participants 1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	FDY-5301 High Dose n=2 Participants 2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	Placebo n=4 Participants Placebo will be administered intravenously once daily for up to 7 days.
Organ Dysfunction Total Time to Recovery	8.5 Days Interval 5.0 to 12.0	4 Days Interval 2.0 to 6.0	6 Days Interval 4.0 to 8.0

SECONDARY outcome

Timeframe: Day 28, or hospital discharge, whichever occurs first

Population: The small number of subjects enrolled in each of the groups preclude interpretation of the MRC-SS data.

Medical Research Council Sum Score (MRC-SS) at Day 28, or hospital discharge, whichever occurs first. The Medical Research Council Sum Score measures global peripheral muscle strength which ranges from 0 (complete paralysis) to 60 (normal strength). A higher score indicates a better outcome.

Outcome measures

Outcome measures
Measure	FDY-5301 Low Dose n=1 Participants 1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	FDY-5301 High Dose 2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	Placebo n=2 Participants Placebo will be administered intravenously once daily for up to 7 days.
Medical Research Council Sum Score	20 Score on a scale Interval 20.0 to	—	31.5 Score on a scale Interval 15.0 to 48.0

SECONDARY outcome

Timeframe: ICU hospital stay until Day 28 or ICU discharge if earlier

Population: The small number of subjects enrolled in each of the groups preclude interpretation of the SOFA data.

The Sequential Organ Failure Assessment (SOFA) is a scoring system that assesses the performance of several organ systems in the body and assigns a score based on the data obtained in each category, this is scored during the ICU stay. The full-length Sequential Organ Failure Assessment score ranges from 0 to 24. A higher score indicates a worse outcome.

Outcome measures

Outcome measures
Measure	FDY-5301 Low Dose n=2 Participants 1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	FDY-5301 High Dose n=2 Participants 2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	Placebo n=4 Participants Placebo will be administered intravenously once daily for up to 7 days.
Sequential Organ Failure Assessment Score	7.5 Score on a scale Interval 6.0 to 9.0	6.5 Score on a scale Interval 6.0 to 7.0	7.5 Score on a scale Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: Day 28

Population: The small number of subjects enrolled in each of the groups preclude interpretation of the Overall Survival at Day 28 data.

Confirmation of survival status will be obtained by speaking directly with subject, via medical records, or public health records.

Outcome measures

Outcome measures
Measure	FDY-5301 Low Dose n=2 Participants 1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	FDY-5301 High Dose n=2 Participants 2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	Placebo n=4 Participants Placebo will be administered intravenously once daily for up to 7 days.
Overall Survival at Day 28	2 Participants	2 Participants	4 Participants

Adverse Events

FDY-5301 Low Dose

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

FDY-5301 High Dose

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FDY-5301 Low Dose n=2 participants at risk 1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	FDY-5301 High Dose n=2 participants at risk 2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	Placebo n=4 participants at risk Placebo will be administered intravenously once daily for up to 7 days.
Injury, poisoning and procedural complications Transfusion reaction	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/4 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Gastrointestinal disorders Ileus	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/4 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.

Other adverse events

Additional Information

Clinical Trial Manager

Faraday Pharmaceuticals, Inc.

Phone: 206-492-5310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Faraday agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Faraday supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial through a multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	FDY-5301 Low Dose n=2 participants at risk 1 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	FDY-5301 High Dose n=2 participants at risk 2 mg/kg FDY-5301 will be administered intravenously once daily for up to 7 days.	Placebo n=4 participants at risk Placebo will be administered intravenously once daily for up to 7 days.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	50.0% 2/4 • Number of events 2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Gastrointestinal disorders Constipation	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/4 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Gastrointestinal disorders Ileus	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
General disorders Pain	100.0% 2/2 • Number of events 2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Infections and infestations Escherichia infection	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Infections and infestations Localised infection	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Infections and infestations Peritonitis	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Infections and infestations Pneumonia	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/4 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Investigations Electrocardiogram T wave abnormal	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Investigations Transaminases increased	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/4 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Nervous system disorders Hyporeflexia	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Psychiatric disorders Anxiety	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Psychiatric disorders Hallucination	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/4 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Psychiatric disorders Insomnia	100.0% 2/2 • Number of events 2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	100.0% 2/2 • Number of events 2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	50.0% 2/4 • Number of events 2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Renal and urinary disorders Oliguria	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/4 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	25.0% 1/4 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Vascular disorders Hypertension	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/4 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.
Vascular disorders Hypotension	50.0% 1/2 • Number of events 1 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/2 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.	0.00% 0/4 • All adverse events occurring from the time of consent until Day 28 were collected. All safety measures are summarized descriptively. AEs are summarized by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term.