Trial Outcomes & Findings for Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury (NCT NCT03403751)

Last Updated: 2021-10-12

Results Overview

Freedom from durable loss of renal function at Day 28 required all of the following 3 components: alive at Day 28, free of dialysis at Day 28, and less than 37% loss of estimated glomerular filtration rate (eGFR) at Day 28 from patient reference eGFR (measured by Modification of Diet in Renal Disease \[MDRD\] formula).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

58 participants

Primary outcome timeframe

28 Days

Results posted on

2021-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Reltecimod 0.5 mg/kg Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Study STARTED	28	30
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Reltecimod 0.5 mg/kg Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Overall Study Death	5	6
Overall Study Discontinuation (includes missing from Day 29)	2	2

Baseline Characteristics

Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)	Total n=58 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 14.6 • n=5 Participants	61.8 years STANDARD_DEVIATION 13.6 • n=7 Participants	61.7 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	29 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Body Mass Index (BMI)	30.5 kg/m^2 STANDARD_DEVIATION 6.9 • n=5 Participants	32.3 kg/m^2 STANDARD_DEVIATION 12.2 • n=7 Participants	31.4 kg/m^2 STANDARD_DEVIATION 9.9 • n=5 Participants
Disease Category Abdominal Infection	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Disease Category Necrotizing Soft Tissue Infection (NSTI)	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Comorbidities Diabetes	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Comorbidities Cardiovascular Disease	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Comorbidities Smoker	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Comorbidities Alcohol Abuse	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Modified Sequential Organ Failure Assessment (mSOFA) Score	4.9 score on a scale STANDARD_DEVIATION 2.3 • n=5 Participants	5.4 score on a scale STANDARD_DEVIATION 3.1 • n=7 Participants	5.1 score on a scale STANDARD_DEVIATION 2.8 • n=5 Participants
Acute Physiology and Chronic Health Evaluation (APACHE) Score	17.1 score on a scale STANDARD_DEVIATION 8.5 • n=5 Participants	16.4 score on a scale STANDARD_DEVIATION 7.9 • n=7 Participants	16.7 score on a scale STANDARD_DEVIATION 8.2 • n=5 Participants
Sepsis Presentation Cardiovascular Organ Failure	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Sepsis Presentation Respiratory Organ Failure	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Acute Kidney Injury (AKI) Presentation Stage 2 AKI	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Acute Kidney Injury (AKI) Presentation Stage 3 AKI	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Acuity of AKI AKI diagnosed at time of diagnosis of infection	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Acuity of AKI AKI diagnosed during the 48h following diagnosis of infection	11 Participants n=5 Participants	18 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed necrotizing soft tissue infection (NSTI) and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Freedom From Durable Loss of Renal Function at Day 28	20 Participants	23 Participants

PRIMARY outcome

Timeframe: 28 Days

Population: This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received.

Number of patients experiencing at least one SAE

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Serious Adverse Events (SAEs)	12 Participants	13 Participants

PRIMARY outcome

Timeframe: 28 Days

The number of patients experiencing at least one AE.

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Adverse Events (AEs)	15 Participants	24 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.

Freedom from durable loss of renal function at Day 14 required all of the following 3 components: alive at Day 14, free of dialysis at Day 14, and less than 37% loss of estimated glomerular filtration rate (eGFR) at Day 14 from patient reference eGFR (measured by Modification of Diet in Renal Disease \[MDRD\] formula).

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Freedom From Durable Loss of Renal Function at Day 14	20 Participants	22 Participants

SECONDARY outcome

Timeframe: 28 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.

ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Intensive Care Unit (ICU)-Free Days	24.0 days Interval 0.0 to 28.0	21.0 days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 28 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.

Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Ventilator-free Days	26.5 days Interval 0.0 to 28.0	26.0 days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 28 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.

Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Vasopressor-free Days	27.5 days Interval 0.0 to 28.0	26.5 days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 90 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.

Hospital days refers to the number of days a patient spent time in the hospital.

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Hospital Days	9.0 days Interval 2.0 to 61.0	13.0 days Interval 1.0 to 60.0

SECONDARY outcome

Timeframe: 90 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received.

The number of deaths occurring through Day 90

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Cumulative Number of Deaths	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 28 Days

Number of patients experiencing at least one secondary infection

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=28 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Secondary Infections	4 Participants	10 Participants

SECONDARY outcome

Timeframe: 28 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis.

The number of days a patient did not spend in the ICU through Day 28, by mSOFA category (mSOFA total score of 1 or less; mSOFA total score of 2 or more). Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=26 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=10 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
ICU-free Days by Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Category	24.0 days Interval 5.0 to 28.0	4.0 days Interval 0.0 to 26.0

SECONDARY outcome

Timeframe: 28 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis.

The number of days a patient was not on a ventilator through Day 28, by mSOFA category

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=26 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=10 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Ventilator-free Days by Day 14 mSOFA Category	27.0 days Interval 8.0 to 28.0	17.0 days Interval 1.0 to 28.0

SECONDARY outcome

Timeframe: 28 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis.

The number of days a patient was not receiving a vasopressor through Day 28, by mSOFA category

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=26 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=10 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Vasopressor-free Days by Day 14 mSOFA Category	28.0 days Interval 24.0 to 28.0	18.0 days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 90 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with available mSOFA data are included in the analysis.

The number of days a patient was in the hospital.

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=26 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=10 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Hospital Days by Day 14 mSOFA Category	13.0 days Interval 4.0 to 48.0	23.5 days Interval 9.0 to 61.0

SECONDARY outcome

Timeframe: 90 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients alive at Day 14 with available data are included in the analysis.

Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other) among patients alive at Day 14.

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=38 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=12 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Hospital Discharge Location by Day 14 mSOFA Category More Favorable Discharge Location	28 Participants	4 Participants
Hospital Discharge Location by Day 14 mSOFA Category Less Favorable Discharge Location	10 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 Days

Population: This analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug (reltecimod or placebo) and who had a suspected or confirmed diagnosis of abdominal sepsis or confirmed NSTI and Stage 2 or Stage 3 AKI, with patients analyzed according to the treatment actually received. Only patients with a screening mSOFA \>= 3 are included in the analysis.

Percentage of patients who died through Day 90 using life table analysis

Outcome measures

Outcome measures
Measure	Reltecimod 0.5 mg/kg n=26 Participants Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=10 Participants Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Cumulative Mortality by Day 14 mSOFA Category	0 percentage of patients	31.4 percentage of patients

Adverse Events

Reltecimod 0.5 mg/kg

Serious events: 12 serious events

Other events: 7 other events

Deaths: 5 deaths

Placebo

Serious events: 13 serious events

Other events: 8 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Reltecimod 0.5 mg/kg n=28 participants at risk Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL)	Placebo n=30 participants at risk Single IV infusion of 0.5 mL/kg of 0.9% sodium chloride (volume equivalent with Reltecimod dosing schema)
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/28 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.	6.7% 2/30 • Number of events 2 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.
Infections and infestations Pneumonia	0.00% 0/28 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.	10.0% 3/30 • Number of events 3 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.
Infections and infestations Sepsis	7.1% 2/28 • Number of events 2 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.	0.00% 0/30 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.
Infections and infestations Septic shock	7.1% 2/28 • Number of events 2 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.	0.00% 0/30 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.
Metabolism and nutrition disorders Fluid overload	7.1% 2/28 • Number of events 2 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.	0.00% 0/30 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.
Psychiatric disorders Delirium	0.00% 0/28 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.	6.7% 2/30 • Number of events 2 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/28 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.	6.7% 2/30 • Number of events 2 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.1% 2/28 • Number of events 2 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.	6.7% 2/30 • Number of events 2 • Adverse events (AEs) reported here were collected from study drug administration through the Day 29 visit (28 days after study drug dosing). Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments.

Additional Information

Wayne M Dankner, MD, Chief Medical Officer

Atox Bio, Ltd.

Phone: 1-919-219-6377

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place