Correlated Drug Terms (1)

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	Name (Synonyms)	Correlation
drug1822	Placebo Wiki	0.06

Correlated MeSH Terms (5)

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	Name (Synonyms)	Correlation
D016638	Critical Illness NIH	0.14
D055371	Acute Lung Injury NIH	0.10
D012127	Respiratory Distress Syndrome, Newborn NIH	0.10
D012128	Respiratory Distress Syndrome, Adult NIH	0.09
D011014	Pneumonia NIH	0.06

Correlated HPO Terms (1)

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	Name (Synonyms)	Correlation
HP:0002090	Pneumonia HPO	0.06

Primary Outcomes

Description: An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.

Measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time: Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD Cohorts

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Secondary Outcomes

Measure: Area Under the Curve from Time 0 to the Time of the Last Measurable Concentration (AUClast)

Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts

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Measure: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)

Time: Baseline and multiple timepoints up to Day 3

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Measure: Maximum Observed Concentration (Cmax)

Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts

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Measure: Time to Reach Maximum Observed Concentration (Tmax)

Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts

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Measure: Elimination Half-Life (t½)

Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts

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Measure: Apparent Total Body Clearance (CL/F)

Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts

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Measure: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)

Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts

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Measure: Amount of BIIB091 Excreted in Urine per Sampling Interval (Aeu)

Time: Baseline and multiple timepoints up to Day 3

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Measure: Percentage of BIIB091 Excreted in Urine per Sampling Interval (%Feu)

Time: Baseline and multiple timepoints up to Day 3

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Measure: Renal clearance (CLr)

Time: Baseline and multiple timepoints up to Day 3

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Measure: Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau)

Time: Baseline and multiple timepoints up to Day 16

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Measure: Accumulation Ratio (R)

Time: Baseline and multiple timepoints up to Day 16

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Measure: Trough concentration (Ctrough)

Time: Baseline and multiple timepoints up to Day 16

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