Trial Outcomes & Findings for A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers (NCT NCT03380780)

Results Overview

Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Results posted on

2019-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Emicizumab Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Age, Continuous	31.6 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Maximum Observed Plasma Concentration (Cmax) of Emicizumab	7.11 microgram per milliliter (μg/mL) Standard Deviation 1.77

PRIMARY outcome

Timeframe: Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Area Under the Plasma Concentration Versus Time Curve (AUC) Between Time Zero Extrapolated to Infinity (AUC0-inf) of Emicizumab	287 μg*day/mL Standard Deviation 74.2

SECONDARY outcome

Timeframe: Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
AUC Between Time Zero and the Time of Last Quantifiable Concentration (AUC0-last) of Emicizumab	268 μg*day/mL Standard Deviation 63.7

SECONDARY outcome

Timeframe: Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Time to Cmax (Tmax) of Emicizumab	7.0 day Interval 3.0 to 15.0

SECONDARY outcome

Timeframe: Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Apparent Terminal Half-Life (t1/2) of Emicizumab	26.7 day Standard Deviation 4.25

SECONDARY outcome

Timeframe: Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Apparent Clearance (CL/F) of Emicizumab	235 milliliter per day (mL/day) Standard Deviation 88

SECONDARY outcome

Timeframe: Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Apparent Volume of Distribution (Vz/F) of Emicizumab	8870 mL Standard Deviation 2950

SECONDARY outcome

Timeframe: Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.

Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Mean Residence Time (MRT) of Emicizumab	40.26 day Standard Deviation 6.34

SECONDARY outcome

Timeframe: From screening to study completion (20 weeks)

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

The WHO Toxicity Grading Scale was used for assessing adverse event severity. Any adverse event not specifically listed in the WHO Toxicity Grading Scale was assessed according to the following levels of severity: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; and Grade 4 is life-threatening. Investigator text for adverse events were encoded using the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. After informed consent had been obtained but prior to initiation of study drug, only serious adverse events (SAEs) caused by a protocol-mandated intervention were to have been reported. After initiation of study drug, all adverse events, regardless of relationship to study drug, were to have been reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Cough - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Any Adverse Event - Any Grade	14 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Any Adverse Event - Grade 1	7 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Any Adverse Event - Grade 2	7 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Any Adverse Event - Grade 3	0 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Any Adverse Event - Grade 4	0 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Leukopenia - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Diarrhoea - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Flatulence - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Mouth ulceration - Grade 2	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Toothache - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Conjunctivitis - Grade 2	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Gastroenteritis - Grade 2	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Pericoronitis - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Upper respiratory tract infection - Grade 1	3 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Upper respiratory tract infection - Grade 2	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Injury - Grade 2	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Road traffic accident - Grade 2	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Blood bilirubin increased - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Blood creatinine phosphokinase increased - Grade 1	4 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Blood triglycerides increased - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Blood uric acid increased - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade C-reactive protein increased - Grade 1	2 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade White blood cell count decreased - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade White blood cell count increased - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Hypertriglyceridaemia - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Hypokalaemia - Grade 2	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Dry throat - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Nasal congestion - Grade 1	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Nasal obstruction - Grade 2	1 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Oropharyngeal pain - Grade 1	3 Participants
Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade Rash - Grade 1	1 Participants

SECONDARY outcome

Timeframe: Predose at Baseline (Day 1) and postdose on Days 57 and 113

Population: Includes participants with at least one predose and one postdose anti-drug antibody (ADA) assessment.

Participants were considered to be 'ADA Negative (Treatment Unaffected)' if baseline and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample. 'Total ADA Positive' is the sum of all participants who tested positive for ADA in the 2 following categories: 'ADA Positive (Treatment Induced)', those who were ADA negative at baseline and tested positive for ADA following study drug administration; and 'ADA Positive (Treatment Boosted)', those who were pre-dose ADA positive and had post-baseline samples with a titer that was at least 4-fold greater compared to the baseline measurement.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study Day 57 - ADA Positive	0 Participants
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study Baseline - ADA Positive	0 Participants
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study Baseline - ADA Negative	16 Participants
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study Day 57 - ADA Negative	16 Participants
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study Day 113 - ADA Positive	1 Participants
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study Day 113 - ADA Negative	15 Participants
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study Overall - ADA Negative (Treatment Unaffected)	15 Participants
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study Overall - Total ADA Positive (Induced + Boosted)	1 Participants
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study Overall - ADA Positive (Treatment Induced)	1 Participants
Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study Overall - ADA Positive (Treatment Boosted)	0 Participants

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 11, 15, 29, 43, 57, 71, 85, and 113

Population: Safety analysis population. The number analyzed in the table below represents the number of participants without the specified laboratory abnormality at baseline. Samples from all participants were analyzed for each laboratory parameter.

The number of participants with a laboratory abnormality during treatment (numerator) is reported among the 'number analyzed' in the table below (denominator), which represents the number of participants without that abnormality at baseline (last observation prior to initiation of study drug). Note that samples from all participants were analyzed for each laboratory parameter. Values falling above or below the Roche predefined standard reference range were laboratory abnormalities labelled accordingly as 'high' or 'low'. Not every laboratory abnormality qualified as an adverse event; only if it was accompanied by clinical symptoms, resulted in a change in study treatment or in a medical intervention, or was clinically significant in the investigator's judgment. SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase; SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Number of Participants With Laboratory Test Abnormalities Activated Partial Thromboplastin Time - Low	13 Participants
Number of Participants With Laboratory Test Abnormalities Eosinophils, Absolute Count - High	2 Participants
Number of Participants With Laboratory Test Abnormalities Urine Specific Gravity - Low	6 Participants
Number of Participants With Laboratory Test Abnormalities Albumin - Low	1 Participants
Number of Participants With Laboratory Test Abnormalities Alkaline Phosphatase - High	2 Participants
Number of Participants With Laboratory Test Abnormalities SGPT/ALT - Low	2 Participants
Number of Participants With Laboratory Test Abnormalities SGOT/AST - Low	5 Participants
Number of Participants With Laboratory Test Abnormalities Blood Urea Nitrogen - Low	1 Participants
Number of Participants With Laboratory Test Abnormalities Blood Urea Nitrogen - High	1 Participants
Number of Participants With Laboratory Test Abnormalities Chloride - Low	2 Participants
Number of Participants With Laboratory Test Abnormalities Cholesterol - Low	5 Participants
Number of Participants With Laboratory Test Abnormalities Cholesterol - High	1 Participants
Number of Participants With Laboratory Test Abnormalities Creatine Kinase - High	3 Participants
Number of Participants With Laboratory Test Abnormalities C-Reactive Protein - High	6 Participants
Number of Participants With Laboratory Test Abnormalities Lactate Dehydrogenase - Low	2 Participants
Number of Participants With Laboratory Test Abnormalities Potassium - Low	1 Participants
Number of Participants With Laboratory Test Abnormalities Sodium - Low	6 Participants
Number of Participants With Laboratory Test Abnormalities Bilirubin - High	2 Participants
Number of Participants With Laboratory Test Abnormalities Protein, Total - Low	3 Participants
Number of Participants With Laboratory Test Abnormalities Triglycerides (Fasting) - High	6 Participants
Number of Participants With Laboratory Test Abnormalities Uric Acid - Low	2 Participants
Number of Participants With Laboratory Test Abnormalities Uric Acid - High	4 Participants
Number of Participants With Laboratory Test Abnormalities Fibrinogen - Low	2 Participants
Number of Participants With Laboratory Test Abnormalities Basophils, Absolute Count - High	4 Participants
Number of Participants With Laboratory Test Abnormalities Eosinophils, Absolute Count - Low	1 Participants
Number of Participants With Laboratory Test Abnormalities Hematocrit - Low	3 Participants
Number of Participants With Laboratory Test Abnormalities Hemoglobin - High	1 Participants
Number of Participants With Laboratory Test Abnormalities Lymphocytes, Absolute Count - Low	4 Participants
Number of Participants With Laboratory Test Abnormalities Lymphocytes, Absolute Count - High	1 Participants
Number of Participants With Laboratory Test Abnormalities Erythrocyte Mean Corpuscular Hemoglobin (HGB)-High	1 Participants
Number of Participants With Laboratory Test Abnormalities Erythro. Mean Corpuscular HGB Concentration - High	8 Participants
Number of Participants With Laboratory Test Abnormalities Monocytes, Absolute Count - High	2 Participants
Number of Participants With Laboratory Test Abnormalities Neutrophils, Total, Absolute Count - Low	2 Participants
Number of Participants With Laboratory Test Abnormalities Neutrophils, Total, Absolute Count - High	2 Participants
Number of Participants With Laboratory Test Abnormalities Platelet - High	1 Participants
Number of Participants With Laboratory Test Abnormalities Red Blood Cell Count - Low	3 Participants
Number of Participants With Laboratory Test Abnormalities White Blood Cell Count - Low	2 Participants
Number of Participants With Laboratory Test Abnormalities Urine pH - High	9 Participants
Number of Participants With Laboratory Test Abnormalities Urine Specific Gravity - High	9 Participants

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Baseline (BL) - Value at Visit	45.43 gram per Liter (g/L) Standard Deviation 1.834
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Change From BL at Day 2	-0.43 gram per Liter (g/L) Standard Deviation 2.391
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Change From BL at Day 4	1.03 gram per Liter (g/L) Standard Deviation 2.016
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Change From BL at Day 8	0.29 gram per Liter (g/L) Standard Deviation 2.095
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Change From BL at Day 15	0.08 gram per Liter (g/L) Standard Deviation 1.928
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Change From BL at Day 29	-0.18 gram per Liter (g/L) Standard Deviation 1.602
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Change From BL at Day 43	-0.41 gram per Liter (g/L) Standard Deviation 1.242
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Change From BL at Day 57	-1.24 gram per Liter (g/L) Standard Deviation 2.298
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Change From BL at Day 71	-0.58 gram per Liter (g/L) Standard Deviation 1.983
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Change From BL at Day 85	-1.56 gram per Liter (g/L) Standard Deviation 2.308
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Change From BL at Day 113	-0.26 gram per Liter (g/L) Standard Deviation 1.732
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Post-BL Minimum Change From BL	-2.87 gram per Liter (g/L) Standard Deviation 1.967
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration Post-BL Maximum Change From BL	1.98 gram per Liter (g/L) Standard Deviation 1.521

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Baseline (BL) - Value at Visit	85.38 unit per Liter (U/L) Standard Deviation 19.500
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Change From BL at Day 2	0.50 unit per Liter (U/L) Standard Deviation 6.792
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Change From BL at Day 4	2.50 unit per Liter (U/L) Standard Deviation 6.542
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Change From BL at Day 8	1.06 unit per Liter (U/L) Standard Deviation 5.813
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Change From BL at Day 15	2.38 unit per Liter (U/L) Standard Deviation 9.150
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Change From BL at Day 29	1.44 unit per Liter (U/L) Standard Deviation 8.959
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Change From BL at Day 43	0.56 unit per Liter (U/L) Standard Deviation 8.756
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Change From BL at Day 57	-3.69 unit per Liter (U/L) Standard Deviation 9.918
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Change From BL at Day 71	-0.94 unit per Liter (U/L) Standard Deviation 11.198
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Change From BL at Day 85	-4.50 unit per Liter (U/L) Standard Deviation 7.589
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Change From BL at Day 113	-0.38 unit per Liter (U/L) Standard Deviation 11.684
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Post-BL Minimum Change From BL	-9.81 unit per Liter (U/L) Standard Deviation 7.556
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration Post-BL Maximum Change From BL	9.94 unit per Liter (U/L) Standard Deviation 7.398

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Baseline (BL) - Value at Visit	13.83 micromole per Liter (μmol/L) Standard Deviation 7.556
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Change From BL at Day 2	0.82 micromole per Liter (μmol/L) Standard Deviation 2.921
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Change From BL at Day 4	-0.42 micromole per Liter (μmol/L) Standard Deviation 4.470
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Change From BL at Day 8	-1.10 micromole per Liter (μmol/L) Standard Deviation 3.713
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Change From BL at Day 15	-0.61 micromole per Liter (μmol/L) Standard Deviation 5.909
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Change From BL at Day 29	-0.56 micromole per Liter (μmol/L) Standard Deviation 4.688
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Change From BL at Day 43	-0.25 micromole per Liter (μmol/L) Standard Deviation 3.709
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Change From BL at Day 57	-0.96 micromole per Liter (μmol/L) Standard Deviation 4.034
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Change From BL at Day 71	1.67 micromole per Liter (μmol/L) Standard Deviation 7.467
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Change From BL at Day 85	0.54 micromole per Liter (μmol/L) Standard Deviation 3.861
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Change From BL at Day 113	-0.12 micromole per Liter (μmol/L) Standard Deviation 5.570
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Post-BL Minimum Change From BL	-3.94 micromole per Liter (μmol/L) Standard Deviation 4.749
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration Post-BL Maximum Change From BL	5.54 micromole per Liter (μmol/L) Standard Deviation 5.909

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Baseline (BL) - Value at Visit	5.03 millimole per Liter (mmol/L) Standard Deviation 0.425
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Change From BL at Day 2	-0.33 millimole per Liter (mmol/L) Standard Deviation 0.384
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Change From BL at Day 4	-0.22 millimole per Liter (mmol/L) Standard Deviation 0.500
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Change From BL at Day 8	-0.16 millimole per Liter (mmol/L) Standard Deviation 0.441
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Change From BL at Day 15	-0.27 millimole per Liter (mmol/L) Standard Deviation 0.382
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Change From BL at Day 29	-0.08 millimole per Liter (mmol/L) Standard Deviation 0.364
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Change From BL at Day 43	-0.08 millimole per Liter (mmol/L) Standard Deviation 0.435
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Change From BL at Day 57	-0.22 millimole per Liter (mmol/L) Standard Deviation 0.515
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Change From BL at Day 71	-0.20 millimole per Liter (mmol/L) Standard Deviation 0.322
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Change From BL at Day 85	-0.25 millimole per Liter (mmol/L) Standard Deviation 0.346
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Change From BL at Day 113	-0.21 millimole per Liter (mmol/L) Standard Deviation 0.470
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Post-BL Minimum Change From BL	-0.64 millimole per Liter (mmol/L) Standard Deviation 0.388
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration Post-BL Maximum Change From BL	0.24 millimole per Liter (mmol/L) Standard Deviation 0.386

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Baseline (BL) - Value at Visit	4.46 millimole per Liter (mmol/L) Standard Deviation 0.848
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Change From BL at Day 2	-0.58 millimole per Liter (mmol/L) Standard Deviation 0.877
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Change From BL at Day 4	-0.73 millimole per Liter (mmol/L) Standard Deviation 0.649
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Change From BL at Day 8	0.26 millimole per Liter (mmol/L) Standard Deviation 1.074
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Change From BL at Day 15	0.43 millimole per Liter (mmol/L) Standard Deviation 1.543
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Change From BL at Day 29	0.43 millimole per Liter (mmol/L) Standard Deviation 1.071
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Change From BL at Day 43	0.38 millimole per Liter (mmol/L) Standard Deviation 0.959
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Change From BL at Day 57	0.39 millimole per Liter (mmol/L) Standard Deviation 0.874
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Change From BL at Day 71	0.36 millimole per Liter (mmol/L) Standard Deviation 0.958
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Change From BL at Day 85	0.16 millimole per Liter (mmol/L) Standard Deviation 0.888
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Change From BL at Day 113	0.13 millimole per Liter (mmol/L) Standard Deviation 0.573
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Post-BL Minimum Change From BL	-1.07 millimole per Liter (mmol/L) Standard Deviation 0.587
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration Post-BL Maximum Change From BL	1.42 millimole per Liter (mmol/L) Standard Deviation 0.970

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Baseline (BL) - Value at Visit	0.50 milligram per Liter (mg/L) Standard Deviation 0.568
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Change From BL at Day 2	0.23 milligram per Liter (mg/L) Standard Deviation 0.456
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Change From BL at Day 29	1.01 milligram per Liter (mg/L) Standard Deviation 1.289
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Change From BL at Day 4	0.11 milligram per Liter (mg/L) Standard Deviation 0.477
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Change From BL at Day 8	0.54 milligram per Liter (mg/L) Standard Deviation 1.721
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Change From BL at Day 15	0.75 milligram per Liter (mg/L) Standard Deviation 1.197
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Change From BL at Day 43	0.60 milligram per Liter (mg/L) Standard Deviation 1.849
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Change From BL at Day 57	0.27 milligram per Liter (mg/L) Standard Deviation 0.827
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Change From BL at Day 71	0.13 milligram per Liter (mg/L) Standard Deviation 0.410
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Change From BL at Day 85	0.12 milligram per Liter (mg/L) Standard Deviation 0.595
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Change From BL at Day 113	1.24 milligram per Liter (mg/L) Standard Deviation 3.517
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Post-BL Minimum Change From BL	-0.20 milligram per Liter (mg/L) Standard Deviation 0.397
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration Post-BL Maximum Change From BL	3.14 milligram per Liter (mg/L) Standard Deviation 3.641

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Change From BL at Day 43	-0.06 millimole per Liter (mmol/L) Standard Deviation 1.731
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Change From BL at Day 85	0.13 millimole per Liter (mmol/L) Standard Deviation 2.630
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Post-BL Minimum Change From BL	-2.94 millimole per Liter (mmol/L) Standard Deviation 2.016
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Baseline (BL) - Value at Visit	104.69 millimole per Liter (mmol/L) Standard Deviation 1.957
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Change From BL at Day 2	-0.69 millimole per Liter (mmol/L) Standard Deviation 2.549
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Change From BL at Day 4	-0.63 millimole per Liter (mmol/L) Standard Deviation 2.363
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Change From BL at Day 8	0.13 millimole per Liter (mmol/L) Standard Deviation 2.579
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Change From BL at Day 15	0.06 millimole per Liter (mmol/L) Standard Deviation 2.175
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Change From BL at Day 29	-1.56 millimole per Liter (mmol/L) Standard Deviation 2.279
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Change From BL at Day 57	0.75 millimole per Liter (mmol/L) Standard Deviation 2.769
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Change From BL at Day 71	-0.50 millimole per Liter (mmol/L) Standard Deviation 2.757
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Change From BL at Day 113	-0.13 millimole per Liter (mmol/L) Standard Deviation 2.217
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration Post-BL Maximum Change From BL	2.31 millimole per Liter (mmol/L) Standard Deviation 2.120

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Post-BL Minimum Change From BL	-0.47 millimole per Liter (mmol/L) Standard Deviation 0.468
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Baseline (BL) - Value at Visit	3.88 millimole per Liter (mmol/L) Standard Deviation 1.103
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Change From BL at Day 2	0.02 millimole per Liter (mmol/L) Standard Deviation 0.393
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Change From BL at Day 4	0.07 millimole per Liter (mmol/L) Standard Deviation 0.439
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Change From BL at Day 8	-0.03 millimole per Liter (mmol/L) Standard Deviation 0.383
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Change From BL at Day 15	-0.04 millimole per Liter (mmol/L) Standard Deviation 0.451
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Change From BL at Day 29	0.03 millimole per Liter (mmol/L) Standard Deviation 0.372
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Change From BL at Day 43	-0.06 millimole per Liter (mmol/L) Standard Deviation 0.441
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Change From BL at Day 57	-0.04 millimole per Liter (mmol/L) Standard Deviation 0.459
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Change From BL at Day 71	-0.01 millimole per Liter (mmol/L) Standard Deviation 0.466
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Change From BL at Day 85	-0.13 millimole per Liter (mmol/L) Standard Deviation 0.515
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Change From BL at Day 113	0.01 millimole per Liter (mmol/L) Standard Deviation 0.394
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration Post-BL Maximum Change From BL	0.47 millimole per Liter (mmol/L) Standard Deviation 0.222

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Change From BL at Day 29	8.50 unit per Liter (U/L) Standard Deviation 122.645
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Change From BL at Day 85	-20.00 unit per Liter (U/L) Standard Deviation 77.283
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Change From BL at Day 113	-18.81 unit per Liter (U/L) Standard Deviation 71.191
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Post-BL Minimum Change From BL	-52.38 unit per Liter (U/L) Standard Deviation 72.902
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Post-BL Maximum Change From BL	92.50 unit per Liter (U/L) Standard Deviation 155.002
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Baseline (BL) - Value at Visit	121.63 unit per Liter (U/L) Standard Deviation 81.915
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Change From BL at Day 2	-41.13 unit per Liter (U/L) Standard Deviation 54.760
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Change From BL at Day 4	-25.81 unit per Liter (U/L) Standard Deviation 107.494
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Change From BL at Day 8	-22.19 unit per Liter (U/L) Standard Deviation 54.034
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Change From BL at Day 15	-0.94 unit per Liter (U/L) Standard Deviation 39.834
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Change From BL at Day 43	-21.00 unit per Liter (U/L) Standard Deviation 53.551
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Change From BL at Day 57	8.00 unit per Liter (U/L) Standard Deviation 152.217
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration Change From BL at Day 71	-19.63 unit per Liter (U/L) Standard Deviation 51.798

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Baseline (BL) - Value at Visit	83.19 micromole per Liter (μmol/L) Standard Deviation 7.195
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Change From BL at Day 2	-0.56 micromole per Liter (μmol/L) Standard Deviation 7.071
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Change From BL at Day 4	-0.31 micromole per Liter (μmol/L) Standard Deviation 5.147
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Change From BL at Day 8	-1.25 micromole per Liter (μmol/L) Standard Deviation 4.919
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Change From BL at Day 15	-2.00 micromole per Liter (μmol/L) Standard Deviation 9.452
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Change From BL at Day 29	-3.69 micromole per Liter (μmol/L) Standard Deviation 4.672
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Change From BL at Day 43	-2.06 micromole per Liter (μmol/L) Standard Deviation 5.434
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Change From BL at Day 57	-2.38 micromole per Liter (μmol/L) Standard Deviation 5.488
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Change From BL at Day 71	-1.06 micromole per Liter (μmol/L) Standard Deviation 7.344
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Change From BL at Day 85	-1.50 micromole per Liter (μmol/L) Standard Deviation 4.662
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Change From BL at Day 113	-0.19 micromole per Liter (μmol/L) Standard Deviation 6.327
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Post-BL Minimum Change From BL	-9.25 micromole per Liter (μmol/L) Standard Deviation 5.170
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration Post-BL Maximum Change From BL	6.13 micromole per Liter (μmol/L) Standard Deviation 6.109

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Baseline (BL) - Value at Visit	1.63 micromole per Liter (μmol/L) Standard Deviation 0.567
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Change From BL at Day 2	0.56 micromole per Liter (μmol/L) Standard Deviation 0.395
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Change From BL at Day 4	0.29 micromole per Liter (μmol/L) Standard Deviation 0.452
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Change From BL at Day 8	0.00 micromole per Liter (μmol/L) Standard Deviation 0.327
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Change From BL at Day 15	-0.07 micromole per Liter (μmol/L) Standard Deviation 0.521
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Change From BL at Day 29	0.12 micromole per Liter (μmol/L) Standard Deviation 0.548
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Change From BL at Day 43	0.12 micromole per Liter (μmol/L) Standard Deviation 0.308
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Change From BL at Day 57	-0.03 micromole per Liter (μmol/L) Standard Deviation 0.342
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Change From BL at Day 71	0.23 micromole per Liter (μmol/L) Standard Deviation 0.509
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Change From BL at Day 85	0.17 micromole per Liter (μmol/L) Standard Deviation 0.515
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Change From BL at Day 113	0.07 micromole per Liter (μmol/L) Standard Deviation 0.480
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Post-BL Minimum Change From BL	-0.39 micromole per Liter (μmol/L) Standard Deviation 0.396
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration Post-BL Maximum Change From BL	0.78 micromole per Liter (μmol/L) Standard Deviation 0.448

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Baseline (BL) - Value at Visit	19.94 unit per Liter (U/L) Standard Deviation 10.951
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Change From BL at Day 2	-0.50 unit per Liter (U/L) Standard Deviation 1.862
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Change From BL at Day 4	0.13 unit per Liter (U/L) Standard Deviation 1.996
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Change From BL at Day 8	0.19 unit per Liter (U/L) Standard Deviation 3.016
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Change From BL at Day 15	-0.13 unit per Liter (U/L) Standard Deviation 10.379
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Change From BL at Day 29	-0.13 unit per Liter (U/L) Standard Deviation 3.202
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Change From BL at Day 43	-0.13 unit per Liter (U/L) Standard Deviation 3.845
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Change From BL at Day 57	-0.25 unit per Liter (U/L) Standard Deviation 4.712
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Change From BL at Day 71	0.13 unit per Liter (U/L) Standard Deviation 5.353
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Change From BL at Day 85	-0.69 unit per Liter (U/L) Standard Deviation 3.790
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Change From BL at Day 113	1.75 unit per Liter (U/L) Standard Deviation 5.756
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Post-BL Minimum Change From BL	-4.81 unit per Liter (U/L) Standard Deviation 7.901
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration Post-BL Maximum Change From BL	5.94 unit per Liter (U/L) Standard Deviation 6.319

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Baseline (BL) - Value at Visit	153.75 unit per Liter (U/L) Standard Deviation 22.228
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Change From BL at Day 2	-10.13 unit per Liter (U/L) Standard Deviation 13.495
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Change From BL at Day 4	-0.19 unit per Liter (U/L) Standard Deviation 15.246
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Change From BL at Day 8	3.19 unit per Liter (U/L) Standard Deviation 11.053
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Change From BL at Day 15	3.19 unit per Liter (U/L) Standard Deviation 17.505
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Change From BL at Day 29	6.56 unit per Liter (U/L) Standard Deviation 17.397
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Change From BL at Day 43	2.38 unit per Liter (U/L) Standard Deviation 11.730
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Change From BL at Day 57	1.69 unit per Liter (U/L) Standard Deviation 11.247
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Change From BL at Day 71	0.19 unit per Liter (U/L) Standard Deviation 15.003
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Change From BL at Day 85	2.63 unit per Liter (U/L) Standard Deviation 16.536
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Change From BL at Day 113	-0.38 unit per Liter (U/L) Standard Deviation 16.141
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Post-BL Minimum Change From BL	-16.06 unit per Liter (U/L) Standard Deviation 11.168
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration Post-BL Maximum Change From BL	22.00 unit per Liter (U/L) Standard Deviation 13.765

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Baseline (BL) - Value at Visit	4.27 millimole per Liter (mmol/L) Standard Deviation 0.351
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Change From BL at Day 2	0.11 millimole per Liter (mmol/L) Standard Deviation 0.401
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Change From BL at Day 4	-0.03 millimole per Liter (mmol/L) Standard Deviation 0.307
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Change From BL at Day 8	0.12 millimole per Liter (mmol/L) Standard Deviation 0.316
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Change From BL at Day 15	-0.02 millimole per Liter (mmol/L) Standard Deviation 0.351
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Change From BL at Day 29	-0.05 millimole per Liter (mmol/L) Standard Deviation 0.337
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Change From BL at Day 43	0.06 millimole per Liter (mmol/L) Standard Deviation 0.366
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Change From BL at Day 57	0.05 millimole per Liter (mmol/L) Standard Deviation 0.507
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Change From BL at Day 71	-0.04 millimole per Liter (mmol/L) Standard Deviation 0.320
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Change From BL at Day 85	-0.19 millimole per Liter (mmol/L) Standard Deviation 0.317
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Change From BL at Day 113	-0.05 millimole per Liter (mmol/L) Standard Deviation 0.371
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Post-BL Minimum Change From BL	-0.47 millimole per Liter (mmol/L) Standard Deviation 0.311
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration Post-BL Maximum Change From BL	0.45 millimole per Liter (mmol/L) Standard Deviation 0.248

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Baseline (BL) - Value at Visit	70.55 gram per Liter (g/L) Standard Deviation 3.485
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Change From BL at Day 2	-0.18 gram per Liter (g/L) Standard Deviation 4.502
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Change From BL at Day 4	2.69 gram per Liter (g/L) Standard Deviation 3.711
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Change From BL at Day 8	1.36 gram per Liter (g/L) Standard Deviation 3.458
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Change From BL at Day 15	0.81 gram per Liter (g/L) Standard Deviation 3.837
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Change From BL at Day 29	1.03 gram per Liter (g/L) Standard Deviation 2.632
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Change From BL at Day 43	-0.03 gram per Liter (g/L) Standard Deviation 2.452
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Change From BL at Day 57	-1.41 gram per Liter (g/L) Standard Deviation 3.502
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Change From BL at Day 71	0.17 gram per Liter (g/L) Standard Deviation 3.720
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Change From BL at Day 85	-1.13 gram per Liter (g/L) Standard Deviation 4.063
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Change From BL at Day 113	0.71 gram per Liter (g/L) Standard Deviation 3.779
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Post-BL Minimum Change From BL	-3.95 gram per Liter (g/L) Standard Deviation 3.488
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration Post-BL Maximum Change From BL	4.54 gram per Liter (g/L) Standard Deviation 2.451

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug. SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Change From BL at Day 85	-0.63 unit per Liter (U/L) Standard Deviation 2.778
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Post-BL Minimum Change From BL	-2.94 unit per Liter (U/L) Standard Deviation 2.594
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Baseline (BL) - Value at Visit	16.63 unit per Liter (U/L) Standard Deviation 2.918
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Change From BL at Day 2	-0.81 unit per Liter (U/L) Standard Deviation 2.007
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Change From BL at Day 4	1.13 unit per Liter (U/L) Standard Deviation 2.941
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Change From BL at Day 8	0.69 unit per Liter (U/L) Standard Deviation 3.240
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Change From BL at Day 15	0.19 unit per Liter (U/L) Standard Deviation 3.728
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Change From BL at Day 29	1.13 unit per Liter (U/L) Standard Deviation 3.304
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Change From BL at Day 43	-0.25 unit per Liter (U/L) Standard Deviation 1.770
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Change From BL at Day 57	0.69 unit per Liter (U/L) Standard Deviation 3.219
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Change From BL at Day 71	-0.31 unit per Liter (U/L) Standard Deviation 2.798
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Change From BL at Day 113	-0.19 unit per Liter (U/L) Standard Deviation 3.920
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration Post-BL Maximum Change From BL	4.75 unit per Liter (U/L) Standard Deviation 3.416

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug. SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Baseline (BL) - Value at Visit	15.63 unit per Liter (U/L) Standard Deviation 6.449
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Change From BL at Day 2	-0.31 unit per Liter (U/L) Standard Deviation 2.798
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Change From BL at Day 4	2.19 unit per Liter (U/L) Standard Deviation 5.419
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Change From BL at Day 8	2.19 unit per Liter (U/L) Standard Deviation 3.953
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Change From BL at Day 15	-0.13 unit per Liter (U/L) Standard Deviation 7.702
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Change From BL at Day 29	0.25 unit per Liter (U/L) Standard Deviation 6.340
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Change From BL at Day 43	-1.69 unit per Liter (U/L) Standard Deviation 5.199
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Change From BL at Day 57	-1.13 unit per Liter (U/L) Standard Deviation 6.490
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Change From BL at Day 71	-0.50 unit per Liter (U/L) Standard Deviation 6.408
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Change From BL at Day 85	-1.13 unit per Liter (U/L) Standard Deviation 5.560
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Change From BL at Day 113	-0.63 unit per Liter (U/L) Standard Deviation 7.571
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Post-BL Minimum Change From BL	-5.13 unit per Liter (U/L) Standard Deviation 6.206
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration Post-BL Maximum Change From BL	8.25 unit per Liter (U/L) Standard Deviation 6.943

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Change From BL at Day 43	-0.13 millimole per Liter (mmol/L) Standard Deviation 2.062
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Baseline (BL) - Value at Visit	140.56 millimole per Liter (mmol/L) Standard Deviation 1.590
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Change From BL at Day 2	-0.44 millimole per Liter (mmol/L) Standard Deviation 1.931
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Change From BL at Day 4	-0.44 millimole per Liter (mmol/L) Standard Deviation 1.931
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Change From BL at Day 8	-0.06 millimole per Liter (mmol/L) Standard Deviation 2.594
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Change From BL at Day 15	0.25 millimole per Liter (mmol/L) Standard Deviation 1.612
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Change From BL at Day 29	-1.75 millimole per Liter (mmol/L) Standard Deviation 2.671
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Change From BL at Day 57	0.06 millimole per Liter (mmol/L) Standard Deviation 2.932
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Change From BL at Day 71	-1.25 millimole per Liter (mmol/L) Standard Deviation 3.130
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Change From BL at Day 85	-0.38 millimole per Liter (mmol/L) Standard Deviation 2.705
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Change From BL at Day 113	-0.13 millimole per Liter (mmol/L) Standard Deviation 1.893
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Post-BL Minimum Change From BL	-3.38 millimole per Liter (mmol/L) Standard Deviation 2.391
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration Post-BL Maximum Change From BL	2.31 millimole per Liter (mmol/L) Standard Deviation 1.922

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Baseline (BL) - Value at Visit	0.98 millimole per Liter (mmol/L) Standard Deviation 0.446
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Change From BL at Day 2	0.37 millimole per Liter (mmol/L) Standard Deviation 0.377
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Change From BL at Day 4	0.57 millimole per Liter (mmol/L) Standard Deviation 0.517
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Change From BL at Day 8	0.03 millimole per Liter (mmol/L) Standard Deviation 0.350
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Change From BL at Day 15	0.22 millimole per Liter (mmol/L) Standard Deviation 0.497
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Change From BL at Day 29	0.15 millimole per Liter (mmol/L) Standard Deviation 0.382
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Change From BL at Day 43	0.17 millimole per Liter (mmol/L) Standard Deviation 0.278
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Change From BL at Day 57	0.27 millimole per Liter (mmol/L) Standard Deviation 0.726
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Change From BL at Day 71	0.14 millimole per Liter (mmol/L) Standard Deviation 0.314
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Change From BL at Day 85	0.28 millimole per Liter (mmol/L) Standard Deviation 0.395
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Change From BL at Day 113	0.33 millimole per Liter (mmol/L) Standard Deviation 0.429
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Post-BL Minimum Change From BL	-0.19 millimole per Liter (mmol/L) Standard Deviation 0.318
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration Post-BL Maximum Change From BL	1.02 millimole per Liter (mmol/L) Standard Deviation 0.490

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Change From BL at Day 29	2.31 micromole per Liter (μmol/L) Standard Deviation 32.946
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Post-BL Maximum Change From BL	79.25 micromole per Liter (μmol/L) Standard Deviation 62.143
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Baseline (BL) - Value at Visit	323.44 micromole per Liter (μmol/L) Standard Deviation 52.081
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Change From BL at Day 2	21.38 micromole per Liter (μmol/L) Standard Deviation 28.329
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Change From BL at Day 4	-15.06 micromole per Liter (μmol/L) Standard Deviation 38.979
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Change From BL at Day 8	-2.88 micromole per Liter (μmol/L) Standard Deviation 35.955
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Change From BL at Day 15	2.44 micromole per Liter (μmol/L) Standard Deviation 49.536
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Change From BL at Day 43	9.63 micromole per Liter (μmol/L) Standard Deviation 45.045
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Change From BL at Day 57	9.38 micromole per Liter (μmol/L) Standard Deviation 53.799
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Change From BL at Day 71	33.81 micromole per Liter (μmol/L) Standard Deviation 84.440
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Change From BL at Day 85	19.25 micromole per Liter (μmol/L) Standard Deviation 50.464
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Change From BL at Day 113	34.56 micromole per Liter (μmol/L) Standard Deviation 62.406
Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration Post-BL Minimum Change From BL	-39.94 micromole per Liter (μmol/L) Standard Deviation 25.870

SECONDARY outcome

Timeframe: Baseline and Days 2, 11, 29, 57, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time Post-BL Minimum Change From BL	-4.83 second Standard Deviation 1.482
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time Baseline (BL) - Value at Visit	31.63 second Standard Deviation 2.111
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time Change From BL at Day 2	-2.79 second Standard Deviation 1.626
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time Change From BL at Day 11	-4.82 second Standard Deviation 1.466
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time Change From BL at Day 29	-3.63 second Standard Deviation 1.643
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time Change From BL at Day 57	-2.14 second Standard Deviation 1.177
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time Change From BL at Day 113	-0.70 second Standard Deviation 1.517
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time Post-BL Maximum Change From BL	-0.56 second Standard Deviation 1.463

SECONDARY outcome

Timeframe: Baseline and Days 2, 11, 29, 57 and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration Post-BL Minimum Change From BL	-0.17 gram per Liter (g/L) Standard Deviation 0.222
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration Baseline (BL) - Value at Visit	2.43 gram per Liter (g/L) Standard Deviation 0.410
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration Change From BL at Day 2	0.18 gram per Liter (g/L) Standard Deviation 0.281
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration Change From BL at Day 11	0.28 gram per Liter (g/L) Standard Deviation 0.314
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration Change From BL at Day 29	0.11 gram per Liter (g/L) Standard Deviation 0.312
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration Change From BL at Day 57	0.05 gram per Liter (g/L) Standard Deviation 0.285
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration Change From BL at Day 113	0.07 gram per Liter (g/L) Standard Deviation 0.438
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration Post-BL Maximum Change From BL	0.53 gram per Liter (g/L) Standard Deviation 0.290

SECONDARY outcome

Timeframe: Baseline and Days 2, 11, 29, 57 and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time Change From BL at Day 2	0.00 second Standard Deviation 0.502
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time Baseline (BL) - Value at Visit	11.33 second Standard Deviation 0.685
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time Change From BL at Day 11	-0.09 second Standard Deviation 0.463
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time Change From BL at Day 29	-0.18 second Standard Deviation 0.455
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time Change From BL at Day 57	-0.18 second Standard Deviation 0.508
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time Change From BL at Day 113	-0.17 second Standard Deviation 0.632
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time Post-BL Minimum Change From BL	-0.58 second Standard Deviation 0.457
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time Post-BL Maximum Change From BL	0.37 second Standard Deviation 0.480

SECONDARY outcome

Timeframe: Baseline and Days 2, 11, 29, 57 and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

The INR is a standardized measure of the prothrombin time. Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR) Baseline (BL) - Value at Visit	1.06 INR of prothrombin time (sec/sec) Standard Deviation 0.062
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR) Change From BL at Day 11	-0.01 INR of prothrombin time (sec/sec) Standard Deviation 0.043
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR) Change From BL at Day 2	0.00 INR of prothrombin time (sec/sec) Standard Deviation 0.044
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR) Change From BL at Day 29	-0.02 INR of prothrombin time (sec/sec) Standard Deviation 0.042
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR) Change From BL at Day 57	-0.02 INR of prothrombin time (sec/sec) Standard Deviation 0.046
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR) Change From BL at Day 113	-0.02 INR of prothrombin time (sec/sec) Standard Deviation 0.057
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR) Post-BL Minimum Change From BL	-0.05 INR of prothrombin time (sec/sec) Standard Deviation 0.042
Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR) Post-BL Maximum Change From BL	0.03 INR of prothrombin time (sec/sec) Standard Deviation 0.043

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Change From BL at Day 4	0.01 *10^9 cells per Liter Standard Deviation 0.018
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Baseline (BL) - Value at Visit	0.02 *10^9 cells per Liter Standard Deviation 0.018
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Change From BL at Day 2	0.00 *10^9 cells per Liter Standard Deviation 0.013
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Change From BL at Day 8	0.01 *10^9 cells per Liter Standard Deviation 0.029
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Change From BL at Day 15	0.01 *10^9 cells per Liter Standard Deviation 0.022
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Change From BL at Day 29	0.01 *10^9 cells per Liter Standard Deviation 0.014
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Change From BL at Day 43	0.01 *10^9 cells per Liter Standard Deviation 0.023
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Change From BL at Day 57	0.01 *10^9 cells per Liter Standard Deviation 0.016
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Change From BL at Day 71	0.01 *10^9 cells per Liter Standard Deviation 0.022
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Change From BL at Day 85	0.00 *10^9 cells per Liter Standard Deviation 0.021
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Change From BL at Day 113	0.01 *10^9 cells per Liter Standard Deviation 0.019
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Post-BL Minimum Change From BL	-0.01 *10^9 cells per Liter Standard Deviation 0.016
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count Post-BL Maximum Change From BL	0.03 *10^9 cells per Liter Standard Deviation 0.021

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Change From BL at Day 4	0.01 *10^9 cells per Liter Standard Deviation 0.066
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Change From BL at Day 8	0.00 *10^9 cells per Liter Standard Deviation 0.066
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Baseline (BL) - Value at Visit	0.14 *10^9 cells per Liter Standard Deviation 0.122
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Change From BL at Day 2	0.02 *10^9 cells per Liter Standard Deviation 0.063
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Change From BL at Day 15	-0.01 *10^9 cells per Liter Standard Deviation 0.074
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Change From BL at Day 29	-0.01 *10^9 cells per Liter Standard Deviation 0.055
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Change From BL at Day 43	0.00 *10^9 cells per Liter Standard Deviation 0.101
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Change From BL at Day 57	-0.02 *10^9 cells per Liter Standard Deviation 0.055
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Change From BL at Day 71	0.01 *10^9 cells per Liter Standard Deviation 0.102
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Change From BL at Day 85	-0.02 *10^9 cells per Liter Standard Deviation 0.063
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Change From BL at Day 113	0.02 *10^9 cells per Liter Standard Deviation 0.121
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Post-BL Minimum Change From BL	-0.06 *10^9 cells per Liter Standard Deviation 0.080
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count Post-BL Maximum Change From BL	0.07 *10^9 cells per Liter Standard Deviation 0.085

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Erythrocyte mean corpuscular hemoglobin (MCH) is a measure of the average amount of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Change From BL at Day 15	-0.12 picogram per cell Standard Deviation 0.472
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Post-BL Minimum Change From BL	-0.40 picogram per cell Standard Deviation 0.412
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Baseline (BL) - Value at Visit	30.84 picogram per cell Standard Deviation 1.815
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Change From BL at Day 2	0.23 picogram per cell Standard Deviation 0.467
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Change From BL at Day 4	0.09 picogram per cell Standard Deviation 0.473
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Change From BL at Day 8	0.26 picogram per cell Standard Deviation 0.594
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Change From BL at Day 29	0.04 picogram per cell Standard Deviation 0.507
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Change From BL at Day 43	0.48 picogram per cell Standard Deviation 0.493
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Change From BL at Day 57	0.28 picogram per cell Standard Deviation 0.567
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Change From BL at Day 71	0.40 picogram per cell Standard Deviation 0.625
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Change From BL at Day 85	0.39 picogram per cell Standard Deviation 0.738
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Change From BL at Day 113	0.51 picogram per cell Standard Deviation 0.933
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Post-BL Maximum Change From BL	1.24 picogram per cell Standard Deviation 0.730

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Erythrocyte mean corpuscular volume is a measure of the average volume of a red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Change From BL at Day 85	0.86 femtoliter (fL) Standard Deviation 1.656
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Post-BL Maximum Change From BL	2.34 femtoliter (fL) Standard Deviation 1.138
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Baseline (BL) - Value at Visit	89.79 femtoliter (fL) Standard Deviation 3.689
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Change From BL at Day 2	-0.14 femtoliter (fL) Standard Deviation 1.172
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Change From BL at Day 4	0.01 femtoliter (fL) Standard Deviation 0.954
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Change From BL at Day 8	0.21 femtoliter (fL) Standard Deviation 1.138
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Change From BL at Day 15	0.88 femtoliter (fL) Standard Deviation 1.036
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Change From BL at Day 29	-0.08 femtoliter (fL) Standard Deviation 0.849
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Change From BL at Day 43	1.41 femtoliter (fL) Standard Deviation 1.670
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Change From BL at Day 57	1.04 femtoliter (fL) Standard Deviation 1.488
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Change From BL at Day 71	0.85 femtoliter (fL) Standard Deviation 1.498
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Change From BL at Day 113	0.62 femtoliter (fL) Standard Deviation 1.775
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume Post-BL Minimum Change From BL	-1.17 femtoliter (fL) Standard Deviation 0.899

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Erythrocyte mean corpuscular hemoglobin concentration (MCHC) is a measure of the average concentration of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Change From BL at Day 57	-0.75 gram per Liter (g/L) Standard Deviation 8.798
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Change From BL at Day 85	1.13 gram per Liter (g/L) Standard Deviation 8.277
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Post-BL Minimum Change From BL	-9.00 gram per Liter (g/L) Standard Deviation 6.143
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Baseline (BL) - Value at Visit	343.25 gram per Liter (g/L) Standard Deviation 8.790
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Change From BL at Day 2	3.13 gram per Liter (g/L) Standard Deviation 6.438
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Change From BL at Day 4	1.00 gram per Liter (g/L) Standard Deviation 7.239
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Change From BL at Day 8	2.31 gram per Liter (g/L) Standard Deviation 5.606
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Change From BL at Day 15	-4.56 gram per Liter (g/L) Standard Deviation 6.562
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Change From BL at Day 29	0.69 gram per Liter (g/L) Standard Deviation 6.019
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Change From BL at Day 43	0.13 gram per Liter (g/L) Standard Deviation 8.853
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Change From BL at Day 71	1.25 gram per Liter (g/L) Standard Deviation 6.372
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Change From BL at Day 113	3.25 gram per Liter (g/L) Standard Deviation 8.004
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration Post-BL Maximum Change From BL	10.56 gram per Liter (g/L) Standard Deviation 6.099

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Hematocrit is a measure of the ratio of red blood cells (RBCs) in the blood by volume. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Baseline (BL) - Value at Visit	0.44 ratio of RBCs in blood (L/L) Standard Deviation 0.020
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Change From BL at Day 2	0.01 ratio of RBCs in blood (L/L) Standard Deviation 0.032
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Change From BL at Day 4	0.01 ratio of RBCs in blood (L/L) Standard Deviation 0.024
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Change From BL at Day 8	0.00 ratio of RBCs in blood (L/L) Standard Deviation 0.023
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Change From BL at Day 15	0.00 ratio of RBCs in blood (L/L) Standard Deviation 0.018
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Change From BL at Day 29	-0.01 ratio of RBCs in blood (L/L) Standard Deviation 0.019
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Change From BL at Day 43	0.00 ratio of RBCs in blood (L/L) Standard Deviation 0.025
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Change From BL at Day 57	-0.01 ratio of RBCs in blood (L/L) Standard Deviation 0.027
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Change From BL at Day 71	0.00 ratio of RBCs in blood (L/L) Standard Deviation 0.027
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Change From BL at Day 85	0.00 ratio of RBCs in blood (L/L) Standard Deviation 0.029
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Change From BL at Day 113	0.01 ratio of RBCs in blood (L/L) Standard Deviation 0.029
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Post-BL Minimum Change From BL	-0.02 ratio of RBCs in blood (L/L) Standard Deviation 0.020
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1) Post-BL Maximum Change From BL	0.02 ratio of RBCs in blood (L/L) Standard Deviation 0.022

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Baseline (BL) - Value at Visit	149.38 gram per Liter (g/L) Standard Deviation 8.065
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Change From BL at Day 2	3.94 gram per Liter (g/L) Standard Deviation 10.056
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Change From BL at Day 4	5.38 gram per Liter (g/L) Standard Deviation 7.571
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Change From BL at Day 8	0.88 gram per Liter (g/L) Standard Deviation 6.551
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Change From BL at Day 15	-2.50 gram per Liter (g/L) Standard Deviation 6.439
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Change From BL at Day 29	-2.50 gram per Liter (g/L) Standard Deviation 7.062
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Change From BL at Day 43	-0.56 gram per Liter (g/L) Standard Deviation 6.345
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Change From BL at Day 57	-1.94 gram per Liter (g/L) Standard Deviation 8.330
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Change From BL at Day 71	0.94 gram per Liter (g/L) Standard Deviation 7.505
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Change From BL at Day 85	0.88 gram per Liter (g/L) Standard Deviation 7.881
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Change From BL at Day 113	3.19 gram per Liter (g/L) Standard Deviation 9.086
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Post-BL Minimum Change From BL	-8.13 gram per Liter (g/L) Standard Deviation 6.076
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration Post-BL Maximum Change From BL	9.63 gram per Liter (g/L) Standard Deviation 5.608

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Baseline (BL) - Value at Visit	1.65 *10^9 cells per Liter Standard Deviation 0.691
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Change From BL at Day 2	0.10 *10^9 cells per Liter Standard Deviation 0.381
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Change From BL at Day 4	0.37 *10^9 cells per Liter Standard Deviation 0.780
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Change From BL at Day 8	0.04 *10^9 cells per Liter Standard Deviation 0.595
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Change From BL at Day 15	-0.09 *10^9 cells per Liter Standard Deviation 0.599
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Change From BL at Day 29	-0.01 *10^9 cells per Liter Standard Deviation 0.422
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Change From BL at Day 43	0.07 *10^9 cells per Liter Standard Deviation 0.470
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Change From BL at Day 57	0.01 *10^9 cells per Liter Standard Deviation 0.464
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Change From BL at Day 71	0.06 *10^9 cells per Liter Standard Deviation 0.372
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Change From BL at Day 85	0.02 *10^9 cells per Liter Standard Deviation 0.397
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Change From BL at Day 113	0.04 *10^9 cells per Liter Standard Deviation 0.585
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Post-BL Minimum Change From BL	-0.35 *10^9 cells per Liter Standard Deviation 0.447
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count Post-BL Maximum Change From BL	0.61 *10^9 cells per Liter Standard Deviation 0.633

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Post-BL Maximum Change From BL	0.11 *10^9 cells per Liter Standard Deviation 0.112
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Baseline (BL) - Value at Visit	0.35 *10^9 cells per Liter Standard Deviation 0.087
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Change From BL at Day 2	-0.04 *10^9 cells per Liter Standard Deviation 0.098
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Change From BL at Day 4	-0.03 *10^9 cells per Liter Standard Deviation 0.111
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Change From BL at Day 8	-0.04 *10^9 cells per Liter Standard Deviation 0.100
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Change From BL at Day 15	-0.01 *10^9 cells per Liter Standard Deviation 0.136
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Change From BL at Day 29	-0.01 *10^9 cells per Liter Standard Deviation 0.112
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Change From BL at Day 43	-0.03 *10^9 cells per Liter Standard Deviation 0.082
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Change From BL at Day 57	-0.04 *10^9 cells per Liter Standard Deviation 0.091
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Change From BL at Day 71	-0.03 *10^9 cells per Liter Standard Deviation 0.075
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Change From BL at Day 85	-0.04 *10^9 cells per Liter Standard Deviation 0.096
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Change From BL at Day 113	-0.02 *10^9 cells per Liter Standard Deviation 0.112
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count Post-BL Minimum Change From BL	-0.10 *10^9 cells per Liter Standard Deviation 0.080

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Baseline (BL) - Value at Visit	3.57 *10^9 cells per Liter Standard Deviation 0.869
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Change From BL at Day 2	-0.24 *10^9 cells per Liter Standard Deviation 0.959
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Change From BL at Day 4	0.12 *10^9 cells per Liter Standard Deviation 0.950
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Change From BL at Day 8	-0.19 *10^9 cells per Liter Standard Deviation 0.809
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Change From BL at Day 15	0.19 *10^9 cells per Liter Standard Deviation 1.043
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Change From BL at Day 29	0.23 *10^9 cells per Liter Standard Deviation 1.063
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Change From BL at Day 43	0.06 *10^9 cells per Liter Standard Deviation 0.961
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Change From BL at Day 57	-0.24 *10^9 cells per Liter Standard Deviation 0.758
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Change From BL at Day 71	-0.06 *10^9 cells per Liter Standard Deviation 0.824
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Change From BL at Day 85	-0.31 *10^9 cells per Liter Standard Deviation 0.686
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Change From BL at Day 113	-0.27 *10^9 cells per Liter Standard Deviation 0.695
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Post-BL Minimum Change From BL	-0.86 *10^9 cells per Liter Standard Deviation 0.708
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count Post-BL Maximum Change From BL	1.16 *10^9 cells per Liter Standard Deviation 0.968

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Baseline (BL) - Value at Visit	231.50 *10^9 cells per Liter Standard Deviation 47.880
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Change From BL at Day 2	-2.13 *10^9 cells per Liter Standard Deviation 25.469
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Change From BL at Day 4	-3.69 *10^9 cells per Liter Standard Deviation 22.330
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Change From BL at Day 8	0.06 *10^9 cells per Liter Standard Deviation 20.612
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Change From BL at Day 15	7.25 *10^9 cells per Liter Standard Deviation 23.023
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Change From BL at Day 29	12.50 *10^9 cells per Liter Standard Deviation 26.967
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Change From BL at Day 43	9.88 *10^9 cells per Liter Standard Deviation 30.265
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Change From BL at Day 57	10.94 *10^9 cells per Liter Standard Deviation 18.908
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Change From BL at Day 71	5.50 *10^9 cells per Liter Standard Deviation 34.131
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Change From BL at Day 85	0.50 *10^9 cells per Liter Standard Deviation 30.542
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Change From BL at Day 113	2.94 *10^9 cells per Liter Standard Deviation 23.778
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Post-BL Minimum Change From BL	-27.31 *10^9 cells per Liter Standard Deviation 17.984
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count Post-BL Maximum Change From BL	36.50 *10^9 cells per Liter Standard Deviation 26.473

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Baseline (BL) - Value at Visit	4.86 *10^12 cells per Liter Standard Deviation 0.304
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Change From BL at Day 2	0.09 *10^12 cells per Liter Standard Deviation 0.327
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Change From BL at Day 4	0.16 *10^12 cells per Liter Standard Deviation 0.247
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Change From BL at Day 8	-0.02 *10^12 cells per Liter Standard Deviation 0.235
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Change From BL at Day 15	-0.07 *10^12 cells per Liter Standard Deviation 0.196
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Change From BL at Day 29	-0.09 *10^12 cells per Liter Standard Deviation 0.209
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Change From BL at Day 43	-0.09 *10^12 cells per Liter Standard Deviation 0.226
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Change From BL at Day 57	-0.11 *10^12 cells per Liter Standard Deviation 0.289
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Change From BL at Day 71	-0.04 *10^12 cells per Liter Standard Deviation 0.266
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Change From BL at Day 85	-0.04 *10^12 cells per Liter Standard Deviation 0.334
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Change From BL at Day 113	0.02 *10^12 cells per Liter Standard Deviation 0.337
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Post-BL Minimum Change From BL	-0.31 *10^12 cells per Liter Standard Deviation 0.242
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count Post-BL Maximum Change From BL	0.26 *10^12 cells per Liter Standard Deviation 0.213

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Baseline (BL) - Value at Visit	5.74 *10^9 cells per Liter Standard Deviation 1.565
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Change From BL at Day 2	-0.17 *10^9 cells per Liter Standard Deviation 1.213
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Change From BL at Day 4	0.33 *10^9 cells per Liter Standard Deviation 1.285
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Change From BL at Day 8	-0.20 *10^9 cells per Liter Standard Deviation 1.222
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Change From BL at Day 15	0.09 *10^9 cells per Liter Standard Deviation 1.400
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Change From BL at Day 29	0.21 *10^9 cells per Liter Standard Deviation 1.026
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Change From BL at Day 43	0.11 *10^9 cells per Liter Standard Deviation 1.162
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Change From BL at Day 57	-0.27 *10^9 cells per Liter Standard Deviation 1.125
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Change From BL at Day 71	-0.01 *10^9 cells per Liter Standard Deviation 1.006
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Change From BL at Day 85	-0.34 *10^9 cells per Liter Standard Deviation 1.064
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Change From BL at Day 113	-0.24 *10^9 cells per Liter Standard Deviation 1.332
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Post-BL Minimum Change From BL	-1.07 *10^9 cells per Liter Standard Deviation 1.071
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count Post-BL Maximum Change From BL	1.29 *10^9 cells per Liter Standard Deviation 0.997

SECONDARY outcome

Timeframe: Baseline and Days 2, 8, 29, 57, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for blood in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Number of Participants by Test Results for Blood in Urine by Timepoint Baseline · 0 (Absent)	15 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Baseline · +1 (Trace)	1 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Baseline · +2 (Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Baseline · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 2 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 2 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 2 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 2 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 8 · 0 (Absent)	15 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 8 · +1 (Trace)	1 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 8 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 8 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 29 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 29 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 29 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 29 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 57 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 57 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 57 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 57 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 85 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 85 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 85 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 85 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 113 · 0 (Absent)	15 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 113 · +1 (Trace)	1 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 113 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Blood in Urine by Timepoint Day 113 · +3/+4 (Strong Positive)	0 Participants

SECONDARY outcome

Timeframe: Baseline and Days 2, 8, 29, 57, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for glucose in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 57 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 57 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 57 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 85 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 85 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 85 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 85 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 113 · 0 (Absent)	15 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 113 · +1 (Trace)	1 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 113 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 113 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 8 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Baseline · 0 (Absent)	16 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Baseline · +1 (Trace)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Baseline · +2 (Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Baseline · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 2 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 2 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 2 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 2 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 8 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 8 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 8 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 29 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 29 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 29 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 29 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Glucose in Urine by Timepoint Day 57 · 0 (Absent)	16 Participants

SECONDARY outcome

Timeframe: Baseline and Days 2, 8, 29, 57, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for protein in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Number of Participants by Test Results for Protein in Urine by Timepoint Day 8 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Baseline · 0 (Absent)	16 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Baseline · +1 (Trace)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Baseline · +2 (Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Baseline · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 2 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 2 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 2 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 2 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 8 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 8 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 57 · +1 (Trace)	1 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 113 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 8 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 29 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 29 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 29 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 29 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 57 · 0 (Absent)	15 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 57 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 57 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 85 · 0 (Absent)	15 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 85 · +1 (Trace)	1 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 85 · +2 (Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 85 · +3/+4 (Strong Positive)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 113 · 0 (Absent)	16 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 113 · +1 (Trace)	0 Participants
Number of Participants by Test Results for Protein in Urine by Timepoint Day 113 · +2 (Positive)	0 Participants

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Baseline (BL) - Value at Visit	66.1 millimeters of mercury (mmHg) Standard Deviation 5.77
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 8	2.7 millimeters of mercury (mmHg) Standard Deviation 5.41
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 43	1.0 millimeters of mercury (mmHg) Standard Deviation 5.18
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 2	-0.8 millimeters of mercury (mmHg) Standard Deviation 4.99
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 4	2.4 millimeters of mercury (mmHg) Standard Deviation 5.21
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 6	3.2 millimeters of mercury (mmHg) Standard Deviation 5.43
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 11	1.4 millimeters of mercury (mmHg) Standard Deviation 5.11
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 15	1.7 millimeters of mercury (mmHg) Standard Deviation 4.24
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 22	3.2 millimeters of mercury (mmHg) Standard Deviation 5.46
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 29	2.6 millimeters of mercury (mmHg) Standard Deviation 5.67
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 36	1.3 millimeters of mercury (mmHg) Standard Deviation 4.48
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 50	3.4 millimeters of mercury (mmHg) Standard Deviation 6.49
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 57	-0.3 millimeters of mercury (mmHg) Standard Deviation 4.64
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 71	1.1 millimeters of mercury (mmHg) Standard Deviation 5.50
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 85	1.3 millimeters of mercury (mmHg) Standard Deviation 4.52
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Change From BL at Day 113	1.3 millimeters of mercury (mmHg) Standard Deviation 4.73
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Post-BL Minimum Change From BL	-5.2 millimeters of mercury (mmHg) Standard Deviation 3.08
Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure Post-BL Maximum Change From BL	8.1 millimeters of mercury (mmHg) Standard Deviation 4.39

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 22	10.2 beats per minute Standard Deviation 9.22
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 71	4.7 beats per minute Standard Deviation 7.07
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 85	6.9 beats per minute Standard Deviation 9.48
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 113	7.4 beats per minute Standard Deviation 8.16
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Baseline (BL) - Value at Visit	61.3 beats per minute Standard Deviation 7.25
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 2	-0.6 beats per minute Standard Deviation 4.72
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 4	1.3 beats per minute Standard Deviation 4.90
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 6	5.8 beats per minute Standard Deviation 7.06
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 8	7.7 beats per minute Standard Deviation 8.58
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 11	9.9 beats per minute Standard Deviation 10.41
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 15	6.9 beats per minute Standard Deviation 5.71
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 29	8.4 beats per minute Standard Deviation 9.24
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 36	6.3 beats per minute Standard Deviation 7.59
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 43	6.2 beats per minute Standard Deviation 7.93
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 50	10.4 beats per minute Standard Deviation 6.98
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Change From BL at Day 57	7.5 beats per minute Standard Deviation 6.75
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Post-BL Minimum Change From BL	-3.1 beats per minute Standard Deviation 4.46
Change From Baseline in Vital Signs by Timepoint: Pulse Rate Post-BL Maximum Change From BL	18.1 beats per minute Standard Deviation 6.29

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Baseline (BL) - Value at Visit	15.5 breaths per minute Standard Deviation 1.51
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 2	0.6 breaths per minute Standard Deviation 1.50
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 4	0.3 breaths per minute Standard Deviation 1.89
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 6	-0.5 breaths per minute Standard Deviation 2.00
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 8	0.8 breaths per minute Standard Deviation 2.64
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 11	0.1 breaths per minute Standard Deviation 2.55
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 15	-0.1 breaths per minute Standard Deviation 2.38
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 22	-0.1 breaths per minute Standard Deviation 2.60
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 29	0.2 breaths per minute Standard Deviation 2.10
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 36	0.9 breaths per minute Standard Deviation 1.54
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 43	-0.3 breaths per minute Standard Deviation 1.88
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 50	0.3 breaths per minute Standard Deviation 2.32
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 57	0.2 breaths per minute Standard Deviation 2.14
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 71	-0.3 breaths per minute Standard Deviation 2.02
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 85	-0.4 breaths per minute Standard Deviation 2.33
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Change From BL at Day 113	0.4 breaths per minute Standard Deviation 2.47
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Post-BL Minimum Change From BL	-3.0 breaths per minute Standard Deviation 1.83
Change From Baseline in Vital Signs by Timepoint: Respiratory Rate Post-BL Maximum Change From BL	2.7 breaths per minute Standard Deviation 1.82

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 43	2.0 millimeters of mercury (mmHg) Standard Deviation 5.97
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Baseline (BL) - Value at Visit	106.8 millimeters of mercury (mmHg) Standard Deviation 7.26
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 2	-1.6 millimeters of mercury (mmHg) Standard Deviation 6.49
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 4	2.4 millimeters of mercury (mmHg) Standard Deviation 5.82
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 6	3.6 millimeters of mercury (mmHg) Standard Deviation 5.86
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 8	3.5 millimeters of mercury (mmHg) Standard Deviation 8.16
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 11	5.1 millimeters of mercury (mmHg) Standard Deviation 8.05
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 15	2.5 millimeters of mercury (mmHg) Standard Deviation 4.97
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 22	4.8 millimeters of mercury (mmHg) Standard Deviation 7.46
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 29	3.2 millimeters of mercury (mmHg) Standard Deviation 8.84
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 36	2.2 millimeters of mercury (mmHg) Standard Deviation 7.49
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 50	5.2 millimeters of mercury (mmHg) Standard Deviation 8.95
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 57	2.2 millimeters of mercury (mmHg) Standard Deviation 7.19
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 71	1.2 millimeters of mercury (mmHg) Standard Deviation 6.35
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 85	2.0 millimeters of mercury (mmHg) Standard Deviation 8.68
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Change From BL at Day 113	1.1 millimeters of mercury (mmHg) Standard Deviation 8.75
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Post-BL Minimum Change From BL	-4.6 millimeters of mercury (mmHg) Standard Deviation 5.76
Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure Post-BL Maximum Change From BL	10.9 millimeters of mercury (mmHg) Standard Deviation 7.47

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 36	-0.19 degrees Celsius (C) Standard Deviation 0.313
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Baseline (BL) - Value at Visit	36.20 degrees Celsius (C) Standard Deviation 0.239
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 2	-0.12 degrees Celsius (C) Standard Deviation 0.281
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 4	0.01 degrees Celsius (C) Standard Deviation 0.263
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 6	-0.09 degrees Celsius (C) Standard Deviation 0.532
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 8	-0.08 degrees Celsius (C) Standard Deviation 0.217
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 11	-0.18 degrees Celsius (C) Standard Deviation 0.414
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 15	-0.06 degrees Celsius (C) Standard Deviation 0.515
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 22	-0.14 degrees Celsius (C) Standard Deviation 0.352
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 29	-0.11 degrees Celsius (C) Standard Deviation 0.433
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 43	-0.16 degrees Celsius (C) Standard Deviation 0.318
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 50	-0.16 degrees Celsius (C) Standard Deviation 0.418
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 57	0.02 degrees Celsius (C) Standard Deviation 0.382
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 71	-0.09 degrees Celsius (C) Standard Deviation 0.360
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 85	-0.21 degrees Celsius (C) Standard Deviation 0.260
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Change From BL at Day 113	-0.02 degrees Celsius (C) Standard Deviation 0.297
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Post-BL Minimum Change From BL	-0.61 degrees Celsius (C) Standard Deviation 0.260
Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary) Post-BL Maximum Change From BL	0.43 degrees Celsius (C) Standard Deviation 0.357

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 2	-0.67 beats per minute Standard Deviation 3.656
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 85	8.25 beats per minute Standard Deviation 8.234
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Post-BL Maximum Change From BL	15.52 beats per minute Standard Deviation 6.259
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Baseline (BL) - Value at Visit	59.90 beats per minute Standard Deviation 5.588
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 4	2.50 beats per minute Standard Deviation 3.978
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 6	6.52 beats per minute Standard Deviation 6.491
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 8	8.63 beats per minute Standard Deviation 7.574
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 15	6.58 beats per minute Standard Deviation 4.250
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 29	8.10 beats per minute Standard Deviation 8.675
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 43	6.96 beats per minute Standard Deviation 7.946
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 57	6.42 beats per minute Standard Deviation 5.793
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 71	5.42 beats per minute Standard Deviation 6.976
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Change From BL at Day 113	7.15 beats per minute Standard Deviation 6.442
Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate Post-BL Minimum Change From BL	-2.21 beats per minute Standard Deviation 2.638

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 8	-4.13 millisecond Standard Deviation 12.692
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 29	-4.10 millisecond Standard Deviation 10.197
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 71	-1.29 millisecond Standard Deviation 9.008
Change From Baseline in ECG Results by Timepoint: PR Duration Baseline (BL) - Value at Visit	160.21 millisecond Standard Deviation 16.023
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 2	0.81 millisecond Standard Deviation 12.767
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 4	-0.10 millisecond Standard Deviation 9.229
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 6	-1.90 millisecond Standard Deviation 9.998
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 15	-1.73 millisecond Standard Deviation 14.577
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 43	-1.79 millisecond Standard Deviation 13.850
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 57	-1.52 millisecond Standard Deviation 10.352
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 85	-5.02 millisecond Standard Deviation 12.450
Change From Baseline in ECG Results by Timepoint: PR Duration Change From BL at Day 113	-1.52 millisecond Standard Deviation 6.576
Change From Baseline in ECG Results by Timepoint: PR Duration Post-BL Minimum Change From BL	-15.21 millisecond Standard Deviation 11.517
Change From Baseline in ECG Results by Timepoint: PR Duration Post-BL Maximum Change From BL	8.83 millisecond Standard Deviation 9.000

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in ECG Results by Timepoint: QRS Duration Baseline (BL) - Value at Visit	98.15 millisecond Standard Deviation 9.074
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 2	0.75 millisecond Standard Deviation 5.514
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 4	1.40 millisecond Standard Deviation 3.077
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 6	-0.71 millisecond Standard Deviation 3.052
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 8	-0.48 millisecond Standard Deviation 4.169
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 15	-0.40 millisecond Standard Deviation 3.221
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 29	-1.00 millisecond Standard Deviation 5.594
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 43	-0.65 millisecond Standard Deviation 2.327
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 57	-1.54 millisecond Standard Deviation 2.494
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 71	0.77 millisecond Standard Deviation 3.429
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 85	-0.46 millisecond Standard Deviation 3.494
Change From Baseline in ECG Results by Timepoint: QRS Duration Change From BL at Day 113	-0.92 millisecond Standard Deviation 3.782
Change From Baseline in ECG Results by Timepoint: QRS Duration Post-BL Minimum Change From BL	-4.19 millisecond Standard Deviation 3.592
Change From Baseline in ECG Results by Timepoint: QRS Duration Post-BL Maximum Change From BL	4.50 millisecond Standard Deviation 3.475

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in ECG Results by Timepoint: QT Duration Baseline (BL) - Value at Visit	398.31 millisecond Standard Deviation 27.123
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 2	-1.35 millisecond Standard Deviation 11.351
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 4	-10.00 millisecond Standard Deviation 13.856
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 6	-12.31 millisecond Standard Deviation 19.791
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 8	-15.69 millisecond Standard Deviation 15.037
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 15	-9.90 millisecond Standard Deviation 13.857
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 29	-11.83 millisecond Standard Deviation 19.322
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 43	-11.96 millisecond Standard Deviation 13.863
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 57	-7.56 millisecond Standard Deviation 16.498
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 71	-4.94 millisecond Standard Deviation 19.933
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 85	-9.75 millisecond Standard Deviation 23.282
Change From Baseline in ECG Results by Timepoint: QT Duration Change From BL at Day 113	-9.21 millisecond Standard Deviation 20.349
Change From Baseline in ECG Results by Timepoint: QT Duration Post-BL Minimum Change From BL	-30.35 millisecond Standard Deviation 14.706
Change From Baseline in ECG Results by Timepoint: QT Duration Post-BL Maximum Change From BL	9.60 millisecond Standard Deviation 12.064

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Baseline (BL) - Value at Visit	398.04 millisecond Standard Deviation 19.275
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 2	-3.81 millisecond Standard Deviation 10.367
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 4	-2.29 millisecond Standard Deviation 8.759
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 6	7.33 millisecond Standard Deviation 8.549
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 8	10.08 millisecond Standard Deviation 13.968
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 15	10.50 millisecond Standard Deviation 10.870
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 29	12.69 millisecond Standard Deviation 12.031
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 43	8.81 millisecond Standard Deviation 13.699
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 57	12.00 millisecond Standard Deviation 9.509
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 71	12.25 millisecond Standard Deviation 12.194
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 85	15.27 millisecond Standard Deviation 13.029
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Change From BL at Day 113	12.08 millisecond Standard Deviation 13.229
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Post-BL Minimum Change From BL	-7.27 millisecond Standard Deviation 8.817
Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula) Post-BL Maximum Change From BL	24.23 millisecond Standard Deviation 11.165

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Baseline (BL) - Value at Visit	397.90 millisecond Standard Deviation 20.554
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 2	-2.98 millisecond Standard Deviation 8.968
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 4	-4.94 millisecond Standard Deviation 9.038
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 6	1.21 millisecond Standard Deviation 9.739
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 8	1.31 millisecond Standard Deviation 9.708
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 15	3.56 millisecond Standard Deviation 10.109
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 29	4.33 millisecond Standard Deviation 8.384
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 43	1.69 millisecond Standard Deviation 8.274
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 57	5.31 millisecond Standard Deviation 8.893
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 71	6.40 millisecond Standard Deviation 11.109
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 85	6.71 millisecond Standard Deviation 12.243
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Change From BL at Day 113	4.81 millisecond Standard Deviation 12.931
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Post-BL Minimum Change From BL	-8.21 millisecond Standard Deviation 8.174
Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula) Post-BL Maximum Change From BL	14.77 millisecond Standard Deviation 10.366

SECONDARY outcome

Timeframe: Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Change From Baseline in ECG Results by Timepoint: RR Duration Baseline (BL) - Value at Visit	1001.06 millisecond Standard Deviation 93.082
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 2	12.73 millisecond Standard Deviation 66.160
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 4	-36.04 millisecond Standard Deviation 60.573
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 6	-94.79 millisecond Standard Deviation 99.788
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 8	-119.67 millisecond Standard Deviation 106.349
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 15	-96.56 millisecond Standard Deviation 67.805
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 29	-114.08 millisecond Standard Deviation 126.347
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 43	-97.98 millisecond Standard Deviation 109.011
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 57	-92.98 millisecond Standard Deviation 87.990
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 71	-82.29 millisecond Standard Deviation 112.001
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 85	-115.87 millisecond Standard Deviation 122.073
Change From Baseline in ECG Results by Timepoint: RR Duration Change From BL at Day 113	-101.02 millisecond Standard Deviation 98.269
Change From Baseline in ECG Results by Timepoint: RR Duration Post-BL Minimum Change From BL	-205.40 millisecond Standard Deviation 91.026
Change From Baseline in ECG Results by Timepoint: RR Duration Post-BL Maximum Change From BL	40.25 millisecond Standard Deviation 49.296

SECONDARY outcome

Timeframe: From screening to study completion (20 weeks)

Population: The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.

The original terms recorded by the investigator for concomitant medications were standardized by the sponsor by assigning preferred terms. The duration of treatment with the concomitant medications ranged from 1 day to 5 days. Except for 1 participant who was treated during the in-clinic period (Days -1 to 4), all other concomitant medications were recorded during the ambulatory period (Days 6 to 113).

Outcome measures

Outcome measures
Measure	Emicizumab n=16 Participants Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Number of Participants With Concomitant Medications Total Participants with at Least 1 Treatment	6 Participants
Number of Participants With Concomitant Medications Analgesics - Paracetamol	1 Participants
Number of Participants With Concomitant Medications Antitrichomonal Agents - Tinidazole	1 Participants
Number of Participants With Concomitant Medications Cephalosporin Antibiotics - Cefadroxil	1 Participants
Number of Participants With Concomitant Medications Cephalosporin Antibiotics - Cefminox	1 Participants
Number of Participants With Concomitant Medications Herbal, Homeopathic, and Dietary Supplements	1 Participants
Number of Participants With Concomitant Medications Non-Steroidal Anti-Inflammatories - Pranoprofen	1 Participants
Number of Participants With Concomitant Medications Proton Pump Inhibitors - Pantoprazole	1 Participants
Number of Participants With Concomitant Medications Salicylates - Aspirin DL-Lysine	1 Participants
Number of Participants With Concomitant Medications Supplements - Potassium Chloride	1 Participants
Number of Participants With Concomitant Medications Supplements - Sodium Chloride	1 Participants
Number of Participants With Concomitant Medications Vitamins and Minerals - Ascorbic Acid	1 Participants

Adverse Events

Emicizumab

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Emicizumab n=16 participants at risk Participants received a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab under fasting conditions on Day 1.
Blood and lymphatic system disorders Leukopenia	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Flatulence	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Mouth ulceration	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Toothache	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Upper respiratory tract infection	25.0% 4/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Conjunctivitis	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Gastroenteritis	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Pericoronitis	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Injury, poisoning and procedural complications Injury	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Injury, poisoning and procedural complications Road traffic accident	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Investigations Blood creatinine phosphokinase increased	25.0% 4/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Investigations C-reactive protein increased	12.5% 2/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Investigations Blood bilirubin increased	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Investigations Blood triglycerides increased	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Investigations Blood uric acid increased	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Investigations White blood cell count decreased	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Investigations White blood cell count increased	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Metabolism and nutrition disorders Hypertriglyceridaemia	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Metabolism and nutrition disorders Hypokalaemia	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	18.8% 3/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Respiratory, thoracic and mediastinal disorders Dry throat	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.
Skin and subcutaneous tissue disorders Rash	6.2% 1/16 • From screening to study completion (20 weeks) Investigators sought information on adverse events (AEs) at each contact with participants. After informed consent but prior to initiation of study drug, only serious AEs (SAEs) caused by a protocol-mandated intervention were to be reported. After initiation of study drug, all AEs, regardless of relationship to study drug, were to be reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER