Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies

An Open-label, Multicenter, Phase 1a/2a Trial Investigating the Safety, Tolerability and Antitumor Activity of Multiple Doses of Sym013, a mAb Mixture Targeting EGFR, HER2 and HER3, in Patients With Advanced Epithelial Malignancies

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02906670

Enrollment

Registered

2016-09-20

Start date

2016-11-01

Completion date

2019-06-30

Last updated

2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncology

Keywords

Epithelial malignancies

Brief summary

This is the first study to test Sym013 (Pan-HER) in humans. The primary purpose of this study is to see if Sym013 is safe and effective for patients with advanced epithelial malignancies without available therapeutic options.

Detailed description

This is an open-label, multicenter trial composed of 2 parts in which Sym013 will be evaluated when administered by intravenous infusion in patients with advanced epithelial malignancies without available therapeutic options. Part 1 is a Phase 1a dose-escalation evaluating weekly (Q1W) and every second week (Q2W) schedules of administration in separate dose-escalation cohorts to determine the recommended phase 2 dose (RP2D) and regimen of Sym013. Part 2 is a Phase 2a dose-expansion at the RP2D and regimen. Four (4) dose-expansion cohorts will be evaluated in this part of the trial and will be selected based upon findings from Part 1, additional preclinical data, and additional clinical data available at that time from other agents inhibiting these targets. Patients will be entered, depending upon either a defined molecular profile or profiles, or their underlying malignancy, to 1 of 4 corresponding expansion cohorts: Cohort A, Cohort B, Cohort C, or Cohort D.

Interventions

DRUGSym013

Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Main inclusion criteria all patients, Part 1 and Part 2: * Male or female, at least 18 years of age at the time of informed consent * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 * Life expectancy \>3 months assessed during Screening * Documented (histologically- or cytologically-proven) epithelial malignancy that is locally advanced or metastatic, having received all therapy known to confer clinical benefit Additional inclusion criteria applicable to Part 2 ONLY: * Epithelial malignancy (tumor types to be determined), measurable according to RECIST v1.1 that has been confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks prior to C1/D1 * Willingness to undergo a pre-and post-dosing biopsy (total of 2 biopsies) from primary or metastatic tumor site(s) considered safe for biopsy

Exclusion criteria

* Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives (whichever is shortest) prior to C1/D1, except nitrosoureas and mitomycin C within 6 weeks prior to C1/D1. * Part 2 ONLY: Radiotherapy against target lesions within 4 weeks prior to C1/D1, unless there is documented progression of the lesion following radiotherapy * Immunosuppressive or systemic hormonal therapy (\>10 mg daily prednisone equivalent) within 2 weeks prior to C1/D1 with exceptions * Use of hematopoietic growth factors within 2 weeks prior to C1/D1 * Active second malignancy or history of another malignancy within the last 3 years, with allowed exceptions * Central nervous system (CNS) malignancies including: 1. Primary malignancies of the CNS 2. Known, untreated CNS or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS metastatic involvement for which treatment is required * Inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy * Major surgical procedure within 4 weeks prior to C1/D1 or inadequate recovery from any prior surgical procedure * Non-healing wounds on any part of the body * Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to C1/D1, unless adequately treated and stable * Active uncontrolled bleeding or a known bleeding diathesis * Significant gastrointestinal abnormalities * Significant cardiovascular disease or condition * Abnormal hematologic, renal or hepatic function

Design outcomes

Primary

Measure	Time frame	Description
Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	24 months	Assess the occurrence of dose-limiting toxicities (DLTs) during Cycle 1 of Sym013 administration.
Part 2: Evaluate the Antitumor Effect of Sym013 When Administered at the RP2D and Regimen to Patients.	24 months	No data were collected for this Outcome Measures as Part 2 of the trial was never initiated.

Secondary

Measure	Time frame	Description
Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W	Will be estimated using non-compartmental methods and actual time points.
Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W	Will be derived from observed data.
Part 1: Determine the RP2D and Regimen of Sym013.	24 months	No RP2D or regimen of Sym013 was determined as the trial was prematurely terminated
Parts 1 and 2: Elimination Half-life (T½).	0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W	Will be estimated using non-compartmental methods and actual time points
Parts 1 and 2: Clearance (CL).	0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W	Will be estimated using non-compartmental methods and actual time points.
Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W	Will be derived from observed data. End of infusion was defined as time zero (0)
Parts 1 and 2: Evaluate the Immunogenicity of Sym013.	42 months	Serum sampling to assess the potential for anti-drug antibody (ADA) formation was not analyzed as the trial was prematurely terminated

Countries

United States

Participant flow

Recruitment details

Patients were only recruited for Part 1; a recommended Phase 2 dose (RP2D) could not be established and the part 2 cohorts A, B, C and were not initiated.

Participants by arm

Arm	Count
1 mg/kg Q1W Phase 1a: Patients are administered a weekly dose of 1 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	1
2 mg/kg Q1W Phase 1a: Patients are administered a weekly dose of 2 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	1
4 mg/kg Q1W Phase 1a: Patients are administered a weekly dose of 4 mg/kg of Sym013 until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	4
6 mg/kg Q1W + Prophylaxis Phase 1a: Patients are administered a weekly dose of 6 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	3
9 mg/kg Q1W + Prophylaxis Phase 1a: Patients are administered a weekly dose of 9 mg/kg of Sym013 + premedication until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	3
6 mg/kg Q2W Phase 1a: Patients are administered a dose of 6 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	3
9 mg/kg Q2W Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw.	7
9 mg/kg Q2W + Prophylaxis Phase 1a: Patients are administered a dose of 9 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	3
12 mg/kg Q2W + Prophylaxis Phase 1a: Patients are administered a dose of 12 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	4
15 mg/kg Q2W + Prophylaxis Phase 1a: Patients are administered a dose of 15 mg/kg of Sym013 + premedication every second week until unacceptable toxicity, progressive disease, termination of the trial or the patient decision to withdraw. Premedications for infusion-related reactions included glucocorticoids and an antihistamine (H1 antagonist) prior to each dose of Pan-HER from the beginning of the study. As of Protocol Amendment 5, additional premedications were added which included montelukast, dexamethasone, antihistamine (H2 antagonist), and acetaminophen.	3
Total	32

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009
Cohort 1, QW	Radiological Progression	1	0	0	0	0	0	0	0	0	0
Cohort 2, QW	Radiological Progression	0	1	0	0	0	0	0	0	0	0
Cohort 3, QW	Lack of Clinical Benefit	0	0	2	0	0	0	0	0	0	0
Cohort 3, QW	Radiological Progression	0	0	2	0	0	0	0	0	0	0
Cohort 4P, QW	Radiological Progression	0	0	0	3	0	0	0	0	0	0
Cohort 4, Q2W	Clinical Progression	0	0	0	0	0	2	0	0	0	0
Cohort 4, Q2W	Radiological Progression	0	0	0	0	0	1	0	0	0	0
Cohort 5P, Q2W	Adverse Event	0	0	0	0	0	0	0	1	0	0
Cohort 5P, Q2W	Radiological Progression	0	0	0	0	0	0	0	2	0	0
Cohort 5P, QW	Radiological Progression	0	0	0	0	3	0	0	0	0	0
Cohort 5, Q2W	Adverse Event	0	0	0	0	0	0	1	0	0	0
Cohort 5, Q2W	Clinical Progression	0	0	0	0	0	0	1	0	0	0
Cohort 5, Q2W	Lack of Clinical Benefit	0	0	0	0	0	0	1	0	0	0
Cohort 5, Q2W	Radiological Progression	0	0	0	0	0	0	4	0	0	0
Cohort 6P, Q2W	Clinical Progression	0	0	0	0	0	0	0	0	3	0
Cohort 6P, Q2W	Radiological Progression	0	0	0	0	0	0	0	0	1	0
Cohort 7P, Q2W	Adverse Event	0	0	0	0	0	0	0	0	0	1
Cohort 7P, Q2W	More than 3 Dose-reduction of Pan-Her	0	0	0	0	0	0	0	0	0	1
Cohort 7P, Q2W	Physician Decision	0	0	0	0	0	0	0	0	0	1

Baseline characteristics

Characteristic	1 mg/kg Q1W	2 mg/kg Q1W	4 mg/kg Q1W	6 mg/kg Q1W + Prophylaxis	9 mg/kg Q1W + Prophylaxis	6 mg/kg Q2W	9 mg/kg Q2W	9 mg/kg Q2W + Prophylaxis	12 mg/kg Q2W + Prophylaxis	15 mg/kg Q2W + Prophylaxis	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants	3 Participants	1 Participants	12 Participants
Age, Categorical Between 18 and 65 years	1 Participants	1 Participants	3 Participants	2 Participants	1 Participants	2 Participants	6 Participants	1 Participants	1 Participants	2 Participants	20 Participants
Age, Continuous	54.0 Years	57.0 Years	59.3 Years STANDARD_DEVIATION 9.74	58.0 Years STANDARD_DEVIATION 6.08	63.3 Years STANDARD_DEVIATION 11.24	56.0 Years STANDARD_DEVIATION 12.12	51.6 Years STANDARD_DEVIATION 11.59	67.3 Years STANDARD_DEVIATION 10.02	63.8 Years STANDARD_DEVIATION 13.77	59.7 Years STANDARD_DEVIATION 8.02	58.7 Years STANDARD_DEVIATION 10.48
Body Mass Index (BMI)	36.2 kg/m^2	26.30 kg/m^2	27.45 kg/m^2 STANDARD_DEVIATION 7.543	26.00 kg/m^2 STANDARD_DEVIATION 2.893	26.93 kg/m^2 STANDARD_DEVIATION 2.409	27.13 kg/m^2 STANDARD_DEVIATION 2.122	26.84 kg/m^2 STANDARD_DEVIATION 5.828	24.03 kg/m^2 STANDARD_DEVIATION 6.584	21.98 kg/m^2 STANDARD_DEVIATION 1.981	31.83 kg/m^2 STANDARD_DEVIATION 9.178	26.75 kg/m^2 STANDARD_DEVIATION 5.575
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants	1 Participants	3 Participants	1 Participants	3 Participants	3 Participants	6 Participants	2 Participants	4 Participants	2 Participants	26 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	1 Participants	1 Participants	3 Participants	3 Participants	2 Participants	2 Participants	6 Participants	2 Participants	4 Participants	3 Participants	27 Participants
Region of Enrollment United States	1 participants	1 participants	4 participants	3 participants	3 participants	3 participants	7 participants	3 participants	4 participants	3 participants	32 participants
Sex: Female, Male Female	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	3 Participants	3 Participants	1 Participants	1 Participants	12 Participants
Sex: Female, Male Male	1 Participants	1 Participants	3 Participants	3 Participants	1 Participants	2 Participants	4 Participants	0 Participants	3 Participants	2 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk
deaths Total, all-cause mortality	0 / 1	0 / 1	0 / 4	0 / 3	0 / 3	1 / 3	0 / 7	0 / 3	0 / 4	0 / 3
other Total, other adverse events	1 / 1	1 / 1	4 / 4	3 / 3	3 / 3	3 / 3	7 / 7	3 / 3	4 / 4	3 / 3
serious Total, serious adverse events	0 / 1	0 / 1	0 / 4	0 / 3	1 / 3	1 / 3	3 / 7	1 / 3	2 / 4	2 / 7

Outcome results

Primary

Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.

Assess the occurrence of dose-limiting toxicities (DLTs) during Cycle 1 of Sym013 administration.

Time frame: 24 months

Population: Pts 84001-007 (9mg/kg Q2W) and 84002-01 (12 mg/kg +P Q2W) did not complete C1 and hence is not considered eligible for DLT assessments.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
1 mg/kg Q1W	Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	0 Participants
2 mg/kg Q1W	Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	0 Participants
4 mg/kg Q1W	Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	0 Participants
6 mg/kg Q1W + Prophylaxis	Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	0 Participants
9 mg/kg Q1W + Prophylaxis	Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	0 Participants
6 mg/kg Q2W	Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	0 Participants
9 mg/kg Q2W	Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	2 Participants
9 mg/kg Q2W + Prophylaxis	Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	0 Participants
12 mg/kg Q2W + Prophylaxis	Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	0 Participants
15 mg/kg Q2W + Prophylaxis	Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.	2 Participants

Primary

Part 2: Evaluate the Antitumor Effect of Sym013 When Administered at the RP2D and Regimen to Patients.

No data were collected for this Outcome Measures as Part 2 of the trial was never initiated.

Time frame: 24 months

Population: The outcome measure was not analyzed, because the study was stopped during Part 1 of the study before initiating Part 2 of the study for business reasons. No data were collected in Part 2

Secondary

Part 1: Determine the RP2D and Regimen of Sym013.

No RP2D or regimen of Sym013 was determined as the trial was prematurely terminated

Time frame: 24 months

Population: No data were collected for this Outcome Measure for Parts 1 and 2

Secondary

Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).

Will be estimated using non-compartmental methods and actual time points.

Time frame: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W

Population: No patients in the 15 mg/kg Q2W + Prophylaxis group proceeded to the 3rd dose Not all patients completed both PK profiles; thus lower patient number in 2nd PK profile than in 1st profile

Arm	Measure	Group	Value (MEAN)	Dispersion
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 3rd/4th dose (2nd PK profile), AUC	880 h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 1st dose (1st PK profile), AUC	267 h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 3rd/4th dose (2nd PK profile), AUC	340 h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 1st dose (1st PK profile), AUC	22 h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 1st dose (1st PK profile), AUC	628 h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 1st dose (1st PK profile), AUC	270 h*µg/mL	Standard Deviation 43
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 3rd/4th dose (2nd PK profile), AUC	1800 h*µg/mL	Standard Deviation 1200
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 1st dose (1st PK profile), AUC	2900 h*µg/mL	Standard Deviation 230
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 3rd/4th dose (2nd PK profile), AUC	1600 h*µg/mL	Standard Deviation 870
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 3rd/4th dose (2nd PK profile), AUC	1300 h*µg/mL	Standard Deviation 720
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 1st dose (1st PK profile), AUC	860 h*µg/mL	Standard Deviation 85
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 3rd/4th dose (2nd PK profile), AUC	2600 h*µg/mL	Standard Deviation 740
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 1st dose (1st PK profile), AUC	880 h*µg/mL	Standard Deviation 130
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 1st dose (1st PK profile), AUC	750 h*µg/mL	Standard Deviation 110
4 mg/kg Q1W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 3rd/4th dose (2nd PK profile), AUC	1600 h*µg/mL	Standard Deviation 1000
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 1st dose (1st PK profile), AUC	1400 h*µg/mL	Standard Deviation 320
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 3rd/4th dose (2nd PK profile), AUC	2100 h*µg/mL	Standard Deviation 200
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 3rd/4th dose (2nd PK profile), AUC	1500 h*µg/mL	Standard Deviation 470
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 3rd/4th dose (2nd PK profile), AUC	6800 h*µg/mL	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 1st dose (1st PK profile), AUC	1480 h*µg/mL	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 1st dose (1st PK profile), AUC	1200 h*µg/mL	Standard Deviation 230
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 1st dose (1st PK profile), AUC	1200 h*µg/mL	Standard Deviation 280
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 1st dose (1st PK profile), AUC	3900 h*µg/mL	Standard Deviation 1100
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 1st dose (1st PK profile), AUC	3900 h*µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 1st dose (1st PK profile), AUC	2100 h*µg/mL	Standard Deviation 640
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 3rd/4th dose (2nd PK profile), AUC	4000 h*µg/mL	Standard Deviation 3100
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 1st dose (1st PK profile), AUC	2300 h*µg/mL	Standard Deviation 680
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 1st dose (1st PK profile), AUC	2200 h*µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 1st dose (1st PK profile), AUC	550 h*µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 3rd/4th dose (2nd PK profile), AUC	2100 h*µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 3rd/4th dose (2nd PK profile), AUC	5600 h*µg/mL	Standard Deviation 4600
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 1st dose (1st PK profile), AUC	2000 h*µg/mL	Standard Deviation 680
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 3rd/4th dose (2nd PK profile), AUC	1800 h*µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 1st dose (1st PK profile), AUC	1100 h*µg/mL	Standard Deviation 310
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 3rd/4th dose (2nd PK profile), AUC	1700 h*µg/mL	Standard Deviation 400
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 1st dose (1st PK profile), AUC	4000 h*µg/mL	Standard Deviation 1500
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 1st dose (1st PK profile), AUC	1000 h*µg/mL	Standard Deviation 310
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 1st dose (1st PK profile), AUC	280 h*µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 3rd/4th dose (2nd PK profile), AUC	3800 h*µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 1st dose (1st PK profile), AUC	1200 h*µg/mL	Standard Deviation 250
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 3rd/4th dose (2nd PK profile), AUC	9900 h*µg/mL	Standard Deviation 2600
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 1st dose (1st PK profile), AUC	2200 h*µg/mL	Standard Deviation 960
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 1st dose (1st PK profile), AUC	2900 h*µg/mL	Standard Deviation 1100
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 1st dose (1st PK profile), AUC	2200 h*µg/mL	Standard Deviation 690
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 3rd/4th dose (2nd PK profile), AUC	2500 h*µg/mL	Standard Deviation 1200
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 1st dose (1st PK profile), AUC	2000 h*µg/mL	Standard Deviation 580
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 3rd/4th dose (2nd PK profile), AUC	2500 h*µg/mL	Standard Deviation 1200
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 3rd/4th dose (2nd PK profile), AUC	1800 h*µg/mL	Standard Deviation 570
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 1st dose (1st PK profile), AUC	6000 h*µg/mL	Standard Deviation 1800
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 3rd/4th dose (2nd PK profile), AUC	760 h*µg/mL	Standard Deviation 300
9 mg/kg Q2W	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 1st dose (1st PK profile), AUC	440 h*µg/mL	Standard Deviation 24
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 3rd/4th dose (2nd PK profile), AUC	9700 h*µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 1st dose (1st PK profile), AUC	2600 h*µg/mL	Standard Deviation 570
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 1st dose (1st PK profile), AUC	3900 h*µg/mL	Standard Deviation 670
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 3rd/4th dose (2nd PK profile), AUC	3100 h*µg/mL	Standard Deviation 870
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 1st dose (1st PK profile), AUC	8900 h*µg/mL	Standard Deviation 3700
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 1st dose (1st PK profile), AUC	2500 h*µg/mL	Standard Deviation 1000
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 3rd/4th dose (2nd PK profile), AUC	4800 h*µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 1st dose (1st PK profile), AUC	2600 h*µg/mL	Standard Deviation 710
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 3rd/4th dose (2nd PK profile), AUC	NA h*µg/mL	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5082, 1st dose (1st PK profile), AUC	19800 h*µg/mL	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu5038, 1st dose (1st PK profile), AUC	13500 h*µg/mL	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1565, 1st dose (1st PK profile), AUC	NA h*µg/mL	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu1277, 1st dose (1st PK profile), AUC	8600 h*µg/mL	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4517, 1st dose (1st PK profile), AUC	17000 h*µg/mL	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).	Hu4384, 1st dose (1st PK profile), AUC	19000 h*µg/mL	—

Secondary

Parts 1 and 2: Clearance (CL).

Will be estimated using non-compartmental methods and actual time points.

Time frame: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W

Population: No patients in the 15 mg/kg Q2W + Prophylaxis group proceeded to the 3rd dose Not all patients completed both PK profiles; thus lower patient number in 2nd PK profile than in 1st profile

Arm	Measure	Group	Value (MEAN)	Dispersion
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4384, 1st dose (1st PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5082, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu1565, 1st dose (1st PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	6Hu1277, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu1277, 1st dose (1st PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5082, 1st dose (1st PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu1565, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4384, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4517, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5038, 1st dose (1st PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4517, 1st dose (1st PK profile), CL	NA mL/h/kg	—
1 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5038, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5082, 3rd/4th dose (2nd PK profile), CL	0.69 mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu1277, 1st dose (1st PK profile), CL	9.8 mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu1565, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu1565, 1st dose (1st PK profile), CL	NA mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4384, 1st dose (1st PK profile), CL	NA mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5038, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4517, 1st dose (1st PK profile), CL	NA mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5038, 1st dose (1st PK profile), CL	NA mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4517, 3rd/4th dose (2nd PK profile), CL	0.86 mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5082, 1st dose (1st PK profile), CL	0.97 mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4384, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
2 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	6Hu1277, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5082, 3rd/4th dose (2nd PK profile), CL	0.49 mL/h/kg	Standard Deviation 0.14
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4384, 1st dose (1st PK profile), CL	0.63 mL/h/kg	Standard Deviation 0.092
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4384, 3rd/4th dose (2nd PK profile), CL	0.36 mL/h/kg	Standard Deviation 0.16
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4517, 1st dose (1st PK profile), CL	0.67 mL/h/kg	Standard Deviation 0.11
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu4517, 3rd/4th dose (2nd PK profile), CL	0.41 mL/h/kg	Standard Deviation 0.2
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5038, 1st dose (1st PK profile), CL	0.60 mL/h/kg	Standard Deviation 0.059
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	6Hu1277, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu1277, 1st dose (1st PK profile), CL	1.6 mL/h/kg	Standard Deviation 0.26
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5082, 1st dose (1st PK profile), CL	0.42 mL/h/kg	Standard Deviation 0.033
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu1565, 1st dose (1st PK profile), CL	NA mL/h/kg	—
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu1565, 3rd/4th dose (2nd PK profile), CL	0.79 mL/h/kg	Standard Deviation 0.37
4 mg/kg Q1W	Parts 1 and 2: Clearance (CL).	Hu5038, 3rd/4th dose (2nd PK profile), CL	0.37 mL/h/kg	Standard Deviation 0.15
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5082, 1st dose (1st PK profile), CL	0.49 mL/h/kg	Standard Deviation 0.14
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1565, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4384, 1st dose (1st PK profile), CL	0.6 mL/h/kg	Standard Deviation 0.12
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1277, 1st dose (1st PK profile), CL	NA mL/h/kg	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4384, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5038, 3rd/4th dose (2nd PK profile), CL	0.55 mL/h/kg	Standard Deviation 0.18
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5038, 1st dose (1st PK profile), CL	0.68 mL/h/kg	Standard Deviation 0.17
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5082, 3rd/4th dose (2nd PK profile), CL	0.27 mL/h/kg	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1565, 1st dose (1st PK profile), CL	0.82 mL/h/kg	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	6Hu1277, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4517, 3rd/4th dose (2nd PK profile), CL	0.42 mL/h/kg	Standard Deviation 0.041
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4517, 1st dose (1st PK profile), CL	0.64 mL/h/kg	Standard Deviation 0.15
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4384, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5038, 1st dose (1st PK profile), CL	0.62 mL/h/kg	Standard Deviation 0.26
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1565, 1st dose (1st PK profile), CL	0.82 mL/h/kg	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4517, 1st dose (1st PK profile), CL	0.62 mL/h/kg	Standard Deviation 0.22
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4384, 1st dose (1st PK profile), CL	0.53 mL/h/kg	Standard Deviation 0.19
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	6Hu1277, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5082, 1st dose (1st PK profile), CL	0.70 mL/h/kg	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5082, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4517, 3rd/4th dose (2nd PK profile), CL	0.35 mL/h/kg	Standard Deviation 0.29
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1277, 1st dose (1st PK profile), CL	1.8 mL/h/kg	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1565, 3rd/4th dose (2nd PK profile), CL	0.86 mL/h/kg	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5038, 3rd/4th dose (2nd PK profile), CL	0.41 mL/h/kg	Standard Deviation 0.31
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu4384, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu1277, 1st dose (1st PK profile), CL	2.3 mL/h/kg	—
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu1565, 1st dose (1st PK profile), CL	NA mL/h/kg	—
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu4384, 1st dose (1st PK profile), CL	0.72 mL/h/kg	Standard Deviation 0.19
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu4517, 1st dose (1st PK profile), CL	0.77 mL/h/kg	Standard Deviation 0.15
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu5038, 1st dose (1st PK profile), CL	0.74 mL/h/kg	Standard Deviation 0.18
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu5082, 1st dose (1st PK profile), CL	0.50 mL/h/kg	Standard Deviation 0.17
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	6Hu1277, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu1565, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu4517, 3rd/4th dose (2nd PK profile), CL	0.54 mL/h/kg	Standard Deviation 0.13
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu5038, 3rd/4th dose (2nd PK profile), CL	0.42 mL/h/kg	—
6 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu5082, 3rd/4th dose (2nd PK profile), CL	0.48 mL/h/kg	—
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu1565, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu5082, 1st dose (1st PK profile), CL	0.49 mL/h/kg	Standard Deviation 0.13
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu4517, 3rd/4th dose (2nd PK profile), CL	0.62 mL/h/kg	Standard Deviation 0.29
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	6Hu1277, 3rd/4th dose (2nd PK profile), CL	1.4 mL/h/kg	Standard Deviation 0.54
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu4384, 1st dose (1st PK profile), CL	0.59 mL/h/kg	Standard Deviation 0.31
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu5038, 3rd/4th dose (2nd PK profile), CL	0.55 mL/h/kg	Standard Deviation 0.25
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu1565, 1st dose (1st PK profile), CL	0.72 mL/h/kg	Standard Deviation 0.31
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu5082, 3rd/4th dose (2nd PK profile), CL	0.29 mL/h/kg	Standard Deviation 0.08
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu5038, 1st dose (1st PK profile), CL	0.64 mL/h/kg	Standard Deviation 0.21
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu4384, 3rd/4th dose (2nd PK profile), CL	0.63 mL/h/kg	Standard Deviation 0.2
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu4517, 1st dose (1st PK profile), CL	0.67 mL/h/kg	Standard Deviation 0.29
9 mg/kg Q2W	Parts 1 and 2: Clearance (CL).	Hu1277, 1st dose (1st PK profile), CL	2.2 mL/h/kg	Standard Deviation 0.12
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4517, 3rd/4th dose (2nd PK profile), CL	0.59 mL/h/kg	Standard Deviation 0.17
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5082, 1st dose (1st PK profile), CL	0.46 mL/h/kg	Standard Deviation 0.17
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1565, 1st dose (1st PK profile), CL	0.64 mL/h/kg	Standard Deviation 0.11
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4384, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5038, 1st dose (1st PK profile), CL	0.68 mL/h/kg	Standard Deviation 0.24
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5082, 3rd/4th dose (2nd PK profile), CL	0.38 mL/h/kg	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4384, 1st dose (1st PK profile), CL	0.55 mL/h/kg	Standard Deviation 0.12
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1565, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5038, 3rd/4th dose (2nd PK profile), CL	0.32 mL/h/kg	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1277, 1st dose (1st PK profile), CL	NA mL/h/kg	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	6Hu1277, 3rd/4th dose (2nd PK profile), CL	NA mL/h/kg	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4517, 1st dose (1st PK profile), CL	0.69 mL/h/kg	Standard Deviation 0.15
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4384, 1st dose (1st PK profile), CL	0.093 mL/h/kg	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu4517, 1st dose (1st PK profile), CL	0.13 mL/h/kg	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1277, 1st dose (1st PK profile), CL	0.19 mL/h/kg	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu1565, 1st dose (1st PK profile), CL	NA mL/h/kg	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5082, 1st dose (1st PK profile), CL	0.23 mL/h/kg	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Clearance (CL).	Hu5038, 1st dose (1st PK profile), CL	0.14 mL/h/kg	—

Secondary

Parts 1 and 2: Elimination Half-life (T½).

Will be estimated using non-compartmental methods and actual time points

Time frame: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W

Population: No patients in the 15 mg/kg Q2W + Prophylaxis group proceeded to the 3rd dose Not all patients completed both PK profiles; thus lower patient number in 2nd PK profile than in 1st profile

Arm	Measure	Group	Value (MEAN)	Dispersion
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 1st dose (1st PK profile), T½	20 H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 1st dose (1st PK profile), T½	29 H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 3rd/4th dose (2nd PK profile), T½	NA H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 3rd/4th dose (2nd PK profile), T½	NA H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 1st dose (1st PK profile), T½	27 H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 3rd/4th dose (2nd PK profile), T½	NA H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 3rd/4th dose (2nd PK profile), T½	NA H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 1st dose (1st PK profile), T½	31 H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 1st dose (1st PK profile), T½	NA H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 1st dose (1st PK profile), T½	NA H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 3rd/4th dose (2nd PK profile), T½	NA H	—
1 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 3rd/4th dose (2nd PK profile), T½	NA H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 3rd/4th dose (2nd PK profile), T½	20 H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 1st dose (1st PK profile), T½	39 H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 3rd/4th dose (2nd PK profile), T½	20 H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 1st dose (1st PK profile), T½	50 H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 3rd/4th dose (2nd PK profile), T½	NA H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 1st dose (1st PK profile), T½	29 H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 3rd/4th dose (2nd PK profile), T½	34 H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 1st dose (1st PK profile), T½	8.3 H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 3rd/4th dose (2nd PK profile), T½	42 H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 1st dose (1st PK profile), T½	50 H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 3rd/4th dose (2nd PK profile), T½	25 H	—
2 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 1st dose (1st PK profile), T½	53 H	—
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 1st dose (1st PK profile), T½	39 H	Standard Deviation 4.7
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 3rd/4th dose (2nd PK profile), T½	111 H	Standard Deviation 90
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 3rd/4th dose (2nd PK profile), T½	69 H	Standard Deviation 50
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 3rd/4th dose (2nd PK profile), T½	28 H	Standard Deviation 9.6
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 1st dose (1st PK profile), T½	36 H	Standard Deviation 5.8
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 1st dose (1st PK profile), T½	39 H	Standard Deviation 5.6
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 1st dose (1st PK profile), T½	18 H	Standard Deviation 4.1
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 3rd/4th dose (2nd PK profile), T½	69 H	Standard Deviation 40
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 1st dose (1st PK profile), T½	66 H	Standard Deviation 7
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 3rd/4th dose (2nd PK profile), T½	43 H	Standard Deviation 26
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 1st dose (1st PK profile), T½	42 H	Standard Deviation 4
4 mg/kg Q1W	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 3rd/4th dose (2nd PK profile), T½	77 H	Standard Deviation 50
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 3rd/4th dose (2nd PK profile), T½	50 H	Standard Deviation 22
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 3rd/4th dose (2nd PK profile), T½	64 H	Standard Deviation 21
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 3rd/4th dose (2nd PK profile), T½	62 H	Standard Deviation 11
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 3rd/4th dose (2nd PK profile), T½	94 H	Standard Deviation 25
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 1st dose (1st PK profile), T½	42 H	Standard Deviation 6.5
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 1st dose (1st PK profile), T½	51 H	Standard Deviation 7.9
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 3rd/4th dose (2nd PK profile), T½	137 H	Standard Deviation 73
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 1st dose (1st PK profile), T½	83 H	Standard Deviation 30
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 1st dose (1st PK profile), T½	29 H	Standard Deviation 2.4
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 3rd/4th dose (2nd PK profile), T½	37 H	Standard Deviation 1.5
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 1st dose (1st PK profile), T½	26 H	Standard Deviation 6
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 1st dose (1st PK profile), T½	43 H	Standard Deviation 5
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 3rd/4th dose (2nd PK profile), T½	35 H	Standard Deviation 7.7
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 3rd/4th dose (2nd PK profile), T½	43 H	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 1st dose (1st PK profile), T½	33 H	Standard Deviation 10
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 3rd/4th dose (2nd PK profile), T½	77 H	Standard Deviation 28
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 1st dose (1st PK profile), T½	62 H	Standard Deviation 12
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 1st dose (1st PK profile), T½	56 H	Standard Deviation 9.8
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 3rd/4th dose (2nd PK profile), T½	85 H	Standard Deviation 27
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 1st dose (1st PK profile), T½	55 H	Standard Deviation 11
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 1st dose (1st PK profile), T½	25 H	Standard Deviation 5.8
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 1st dose (1st PK profile), T½	96 H	Standard Deviation 33
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 3rd/4th dose (2nd PK profile), T½	152 H	Standard Deviation 105
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 3rd/4th dose (2nd PK profile), T½	175 H	Standard Deviation 71
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 1st dose (1st PK profile), T½	47 H	Standard Deviation 16
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 1st dose (1st PK profile), T½	21 H	Standard Deviation 9.2
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 1st dose (1st PK profile), T½	35 H	Standard Deviation 5
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 3rd/4th dose (2nd PK profile), T½	39 H	Standard Deviation 3.6
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 1st dose (1st PK profile), T½	59 H	Standard Deviation 18
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 1st dose (1st PK profile), T½	50 H	Standard Deviation 16
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 1st dose (1st PK profile), T½	90 H	Standard Deviation 33
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 3rd/4th dose (2nd PK profile), T½	27 H	Standard Deviation 5.5
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 3rd/4th dose (2nd PK profile), T½	44 H	Standard Deviation 3.7
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 3rd/4th dose (2nd PK profile), T½	70 H	Standard Deviation 3
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 3rd/4th dose (2nd PK profile), T½	59 H	Standard Deviation 22
6 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 3rd/4th dose (2nd PK profile), T½	119 H	Standard Deviation 54
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 1st dose (1st PK profile), T½	45 H	Standard Deviation 14
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 3rd/4th dose (2nd PK profile), T½	39 H	Standard Deviation 8.3
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 3rd/4th dose (2nd PK profile), T½	26 H	Standard Deviation 7
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 1st dose (1st PK profile), T½	51 H	Standard Deviation 12
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 1st dose (1st PK profile), T½	96 H	Standard Deviation 29
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 3rd/4th dose (2nd PK profile), T½	79 H	Standard Deviation 35
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 1st dose (1st PK profile), T½	54 H	Standard Deviation 15
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 1st dose (1st PK profile), T½	30 H	Standard Deviation 20
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 1st dose (1st PK profile), T½	56 H	Standard Deviation 19
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 3rd/4th dose (2nd PK profile), T½	84 H	Standard Deviation 49
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 3rd/4th dose (2nd PK profile), T½	103 H	Standard Deviation 30
9 mg/kg Q2W	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 3rd/4th dose (2nd PK profile), T½	78 H	Standard Deviation 41
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 3rd/4th dose (2nd PK profile), T½	48 H	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 1st dose (1st PK profile), T½	39 H	Standard Deviation 7.2
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 3rd/4th dose (2nd PK profile), T½	61 H	Standard Deviation 7.4
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 3rd/4th dose (2nd PK profile), T½	48 H	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 3rd/4th dose (2nd PK profile), T½	31 H	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 3rd/4th dose (2nd PK profile), T½	64 H	Standard Deviation 35
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 1st dose (1st PK profile), T½	97 H	Standard Deviation 34
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 1st dose (1st PK profile), T½	54 H	Standard Deviation 23
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 1st dose (1st PK profile), T½	52 H	Standard Deviation 8.2
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 1st dose (1st PK profile), T½	73 H	Standard Deviation 13
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 1st dose (1st PK profile), T½	55 H	Standard Deviation 11
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 3rd/4th dose (2nd PK profile), T½	177 H	Standard Deviation 122
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4384, 1st dose (1st PK profile), T½	92 H	Standard Deviation 48
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5038, 1st dose (1st PK profile), T½	78 H	Standard Deviation 44
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu4517, 1st dose (1st PK profile), T½	73 H	Standard Deviation 32
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu5082, 1st dose (1st PK profile), T½	93 H	Standard Deviation 62
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1565, 1st dose (1st PK profile), T½	66 H	Standard Deviation 24
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Elimination Half-life (T½).	Hu1277, 1st dose (1st PK profile), T½	56 H	Standard Deviation 18

Secondary

Parts 1 and 2: Evaluate the Immunogenicity of Sym013.

Serum sampling to assess the potential for anti-drug antibody (ADA) formation was not analyzed as the trial was prematurely terminated

Time frame: 42 months

Population: No data were collected for this Outcome Measure for Parts 1 and 2

Secondary

Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.

Will be derived from observed data.

Time frame: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W

Population: No patients in the 15 mg/kg Q2W + Prophylaxis group proceeded to the 3rd dose Not all patients completed both PK profiles; thus lower patient number in 2nd PK profile than in 1st profile

Arm	Measure	Group	Value (MEAN)	Dispersion
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Cmax	8.4 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Cmax	3.0 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Cmax	9.5 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Cmax	10 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Cmax	7.7 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Cmax	2.5 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Cmax	3.2 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Cmax	8.3 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Cmax	7.2 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Cmax	0.78 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Cmax	2.5 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Cmax	2.9 µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
1 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Ctrough	0.32 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Cmax	7.5 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Cmax	4.7 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Cmax	1.8 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Cmax	6.1 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Ctrough	0.38 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Cmax	7.0 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Cmax	15 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Cmax	4.9 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Ctrough	0.92 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Cmax	9.8 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Cmax	8.3 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Cmax	4.1 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Cmax	3.0 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Ctrough	1.9 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Cmax	5.6 µg/mL	—
2 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Ctrough	0.59 µg/mL	—
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Ctrough	0.59 µg/mL	Standard Deviation 0.36
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Ctrough	4.8 µg/mL	Standard Deviation 0.7
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Cmax	11 µg/mL	Standard Deviation 1.3
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Cmax	47 µg/mL	Standard Deviation 9.6
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Cmax	21 µg/mL	Standard Deviation 4.3
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Cmax	10 µg/mL	Standard Deviation 3
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Ctrough	1.9 µg/mL	Standard Deviation 0.4
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Cmax	18 µg/mL	Standard Deviation 2.1
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Cmax	16 µg/mL	Standard Deviation 6.2
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Ctrough	2.1 µg/mL	Standard Deviation 0.9
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Cmax	19 µg/mL	Standard Deviation 2.5
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Cmax	17 µg/mL	Standard Deviation 2.2
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Ctrough	1.9 µg/mL	Standard Deviation 0.8
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Ctrough	0.72 µg/mL	Standard Deviation 0.31
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Ctrough	7.1 µg/mL	Standard Deviation 6.1
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Cmax	17 µg/mL	Standard Deviation 2.6
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Cmax	16 µg/mL	Standard Deviation 2.3
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Ctrough	0.49 µg/mL	—
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Ctrough	0.79 µg/mL	Standard Deviation 0.24
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Cmax	22 µg/mL	Standard Deviation 3
4 mg/kg Q1W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Cmax	42 µg/mL	Standard Deviation 6.5
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Cmax	31 µg/mL	Standard Deviation 8.1
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Ctrough	1.5 µg/mL	Standard Deviation 0.9
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Ctrough	4.9 µg/mL	Standard Deviation 3.4
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Cmax	24 µg/mL	Standard Deviation 4
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Cmax	22 µg/mL	Standard Deviation 3.2
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Ctrough	8.9 µg/mL	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Ctrough	9.3 µg/mL	Standard Deviation 6.3
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Cmax	29 µg/mL	Standard Deviation 4
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Cmax	15 µg/mL	Standard Deviation 3.1
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Ctrough	0.82 µg/mL	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Ctrough	3.8 µg/mL	Standard Deviation 2.7
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Cmax	17 µg/mL	Standard Deviation 2.3
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Ctrough	1.3 µg/mL	Standard Deviation 1.1
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Cmax	31 µg/mL	Standard Deviation 5.6
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Cmax	35 µg/mL	Standard Deviation 8.7
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Ctrough	6.6 µg/mL	Standard Deviation 4.7
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Ctrough	28 µg/mL	Standard Deviation 16
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Cmax	55 µg/mL	Standard Deviation 11
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Ctrough	1.4 µg/mL	Standard Deviation 0.9
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Cmax	97 µg/mL	Standard Deviation 42
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Cmax	30 µg/mL	Standard Deviation 4.2
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Cmax	27 µg/mL	Standard Deviation 4.5
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Ctrough	3.3 µg/mL	Standard Deviation 1.9
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Cmax	23 µg/mL	Standard Deviation 2.6
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Cmax	44 µg/mL	Standard Deviation 3.1
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Ctrough	0.85 µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Cmax	30 µg/mL	Standard Deviation 2.3
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Cmax	36 µg/mL	Standard Deviation 4.2
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Ctrough	3.0 µg/mL	Standard Deviation 1.5
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Cmax	31 µg/mL	Standard Deviation 2.4
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Ctrough	2.8 µg/mL	Standard Deviation 1.8
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Cmax	67 µg/mL	Standard Deviation 6.3
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Ctrough	16 µg/mL	Standard Deviation 11
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Cmax	30 µg/mL	Standard Deviation 6.6
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Cmax	54 µg/mL	Standard Deviation 10
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Ctrough	2.5 µg/mL	Standard Deviation 0.3
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Cmax	48 µg/mL	Standard Deviation 21
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Ctrough	10 µg/mL	Standard Deviation 7
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Cmax	57 µg/mL	Standard Deviation 19
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Ctrough	5.4 µg/mL	Standard Deviation 1
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Cmax	44 µg/mL	Standard Deviation 9.1
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Ctrough	4.5 µg/mL	Standard Deviation 1.9
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Cmax	82 µg/mL	Standard Deviation 23
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Ctrough	31 µg/mL	Standard Deviation 20
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Cmax	18 µg/mL	Standard Deviation 2.9
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Cmax	19 µg/mL	Standard Deviation 3.6
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Ctrough	0.66 µg/mL	Standard Deviation 0.22
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Cmax	13 µg/mL	Standard Deviation 1.6
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Cmax	29 µg/mL	Standard Deviation 5.7
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Cmax	12 µg/mL	Standard Deviation 2.5
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Cmax	20 µg/mL	Standard Deviation 2.9
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Cmax	25 µg/mL	Standard Deviation 3.9
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Ctrough	6.8 µg/mL	Standard Deviation 6.8
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Ctrough	0.81 µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Ctrough	2.5 µg/mL	Standard Deviation 2.2
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Cmax	21 µg/mL	Standard Deviation 4.1
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Cmax	21 µg/mL	Standard Deviation 0.8
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Cmax	39 µg/mL	Standard Deviation 12
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Cmax	51 µg/mL	Standard Deviation 6.8
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Ctrough	0.43 µg/mL	Standard Deviation 0.05
6 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Cmax	16 µg/mL	Standard Deviation 3
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Cmax	37 µg/mL	Standard Deviation 16
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Ctrough	1.3 µg/mL	Standard Deviation 1.1
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Cmax	29 µg/mL	Standard Deviation 12
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Cmax	42 µg/mL	Standard Deviation 14
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Cmax	43 µg/mL	Standard Deviation 17
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Ctrough	1.4 µg/mL	Standard Deviation 1.2
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Ctrough	0.57 µg/mL	Standard Deviation 0.24
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Cmax	77 µg/mL	Standard Deviation 32
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Ctrough	0.66 µg/mL	Standard Deviation 0.22
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Cmax	28 µg/mL	Standard Deviation 11
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Cmax	37 µg/mL	Standard Deviation 13
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Cmax	99 µg/mL	Standard Deviation 31
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Ctrough	6.2 µg/mL	Standard Deviation 6.2
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Ctrough	1.5 µg/mL	Standard Deviation 1.8
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Cmax	57 µg/mL	Standard Deviation 21
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Ctrough	0.69 µg/mL	Standard Deviation 0.55
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Cmax	20 µg/mL	Standard Deviation 9
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Cmax	43 µg/mL	Standard Deviation 13
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Ctrough	4.3 µg/mL	Standard Deviation 2
9 mg/kg Q2W	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Cmax	30 µg/mL	Standard Deviation 11
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Cmax	25 µg/mL	Standard Deviation 3.7
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Ctrough	0.86 µg/mL	Standard Deviation 0.29
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Cmax	60 µg/mL	Standard Deviation 8.8
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Cmax	34 µg/mL	Standard Deviation 3.9
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Cmax	120 µg/mL	Standard Deviation 21
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Ctrough	0.61 µg/mL	Standard Deviation 0.21
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Cmax	34 µg/mL	Standard Deviation 3.6
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Cmax	38 µg/mL	Standard Deviation 3.9
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 3rd/4th dose (2nd PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Ctrough	1.4 µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Cmax	45 µg/mL	Standard Deviation 5.6
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Cmax	31 µg/mL	Standard Deviation 3.7
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 3rd/4th dose (2nd PK profile), Ctrough	0.75 µg/mL	Standard Deviation 0.41
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 3rd/4th dose (2nd PK profile), Ctrough	22 µg/mL	Standard Deviation 22
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Cmax	41 µg/mL	Standard Deviation 3.9
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Cmax	48 µg/mL	Standard Deviation 6.3
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 3rd/4th dose (2nd PK profile), Ctrough	2.6 µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Ctrough	NA µg/mL	—
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Ctrough	7.8 µg/mL	Standard Deviation 3.7
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 3rd/4th dose (2nd PK profile), Cmax	29 µg/mL	Standard Deviation 3.9
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Cmax	89 µg/mL	Standard Deviation 14
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Ctrough	34 µg/mL	Standard Deviation 43
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Cmax	87 µg/mL	Standard Deviation 32
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Cmax	92 µg/mL	Standard Deviation 45
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4384, 1st dose (1st PK profile), Ctrough	19 µg/mL	Standard Deviation 23
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5082, 1st dose (1st PK profile), Cmax	160 µg/mL	Standard Deviation 45
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu5038, 1st dose (1st PK profile), Ctrough	15 µg/mL	Standard Deviation 19
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Cmax	110 µg/mL	Standard Deviation 55
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Cmax	66 µg/mL	Standard Deviation 21
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1277, 1st dose (1st PK profile), Ctrough	16 µg/mL	—
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu4517, 1st dose (1st PK profile), Ctrough	16 µg/mL	Standard Deviation 22
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Cmax	130 µg/mL	Standard Deviation 34
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.	Hu1565, 1st dose (1st PK profile), Ctrough	50 µg/mL	—

Secondary

Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).

Will be derived from observed data. End of infusion was defined as time zero (0)

Time frame: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours if Q2W

Population: No patients in the 15 mg/kg Q2W + Prophylaxis group proceeded to the 3rd dose Not all patients completed both PK profiles; thus lower patient number in 2nd PK profile than in 1st profile

Arm	Measure	Group	Value (MEAN)	Dispersion
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 1st dose (1st PK profile), Tmax	0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 1st dose (1st PK profile), Tmax	0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 1st dose (1st PK profile), Tmax	2.0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 1st dose (1st PK profile), Tmax	0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 3rd/4th dose (2nd PK profile), Tmax	7.0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 3rd/4th dose (2nd PK profile), Tmax	0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 3rd/4th dose (2nd PK profile), Tmax	7.0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 1st dose (1st PK profile), Tmax	0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 3rd/4th dose (2nd PK profile), Tmax	7.0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 1st dose (1st PK profile), Tmax	0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 3rd/4th dose (2nd PK profile), Tmax	7.0 h	—
1 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 3rd/4th dose (2nd PK profile), Tmax	7.0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 3rd/4th dose (2nd PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 1st dose (1st PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 3rd/4th dose (2nd PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 1st dose (1st PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 3rd/4th dose (2nd PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 1st dose (1st PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 3rd/4th dose (2nd PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 3rd/4th dose (2nd PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 1st dose (1st PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 3rd/4th dose (2nd PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 1st dose (1st PK profile), Tmax	0 h	—
2 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 1st dose (1st PK profile), Tmax	0 h	—
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 1st dose (1st PK profile), Tmax	2.5 h	Standard Deviation 1.9
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 3rd/4th dose (2nd PK profile), Tmax	2.9 h	Standard Deviation 2.4
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 3rd/4th dose (2nd PK profile), Tmax	1.0 h	Standard Deviation 2
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 3rd/4th dose (2nd PK profile), Tmax	0.48 h	Standard Deviation 0.96
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 1st dose (1st PK profile), Tmax	2.5 h	Standard Deviation 1.9
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 1st dose (1st PK profile), Tmax	2.5 h	Standard Deviation 1.9
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 1st dose (1st PK profile), Tmax	2.5 h	Standard Deviation 1.9
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 3rd/4th dose (2nd PK profile), Tmax	0.48 h	Standard Deviation 0.96
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 1st dose (1st PK profile), Tmax	2.5 h	Standard Deviation 1.9
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 3rd/4th dose (2nd PK profile), Tmax	0 h	Standard Deviation 0
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 1st dose (1st PK profile), Tmax	2.5 h	Standard Deviation 1.9
4 mg/kg Q1W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 3rd/4th dose (2nd PK profile), Tmax	1.4 h	Standard Deviation 1.8
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 3rd/4th dose (2nd PK profile), Tmax	1.3 h	Standard Deviation 2.3
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 1st dose (1st PK profile), Tmax	2.0 h	Standard Deviation 2
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 3rd/4th dose (2nd PK profile), Tmax	0 h	Standard Deviation 0
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 3rd/4th dose (2nd PK profile), Tmax	0 h	Standard Deviation 0
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 1st dose (1st PK profile), Tmax	2.0 h	Standard Deviation 2
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 1st dose (1st PK profile), Tmax	0.65 h	Standard Deviation 1.1
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 3rd/4th dose (2nd PK profile), Tmax	1.9 h	Standard Deviation 2
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 1st dose (1st PK profile), Tmax	0.65 h	Standard Deviation 1.1
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 1st dose (1st PK profile), Tmax	0.65 h	Standard Deviation 1.1
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 3rd/4th dose (2nd PK profile), Tmax	0 h	Standard Deviation 0
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 1st dose (1st PK profile), Tmax	2.0 h	Standard Deviation 2
6 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 3rd/4th dose (2nd PK profile), Tmax	0 h	Standard Deviation 0
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 3rd/4th dose (2nd PK profile), Tmax	1.3 h	Standard Deviation 2.3
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 3rd/4th dose (2nd PK profile), Tmax	2.5 h	Standard Deviation 2.2
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 1st dose (1st PK profile), Tmax	2.3 h	Standard Deviation 1.1
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 3rd/4th dose (2nd PK profile), Tmax	1.3 h	Standard Deviation 2.3
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 1st dose (1st PK profile), Tmax	2.3 h	Standard Deviation 1.1
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 1st dose (1st PK profile), Tmax	1.1 h	Standard Deviation 0.97
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 3rd/4th dose (2nd PK profile), Tmax	1.3 h	Standard Deviation 2.3
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 1st dose (1st PK profile), Tmax	1.1 h	Standard Deviation 0.97
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 1st dose (1st PK profile), Tmax	1.1 h	Standard Deviation 1
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 1st dose (1st PK profile), Tmax	1.1 h	Standard Deviation 0.97
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 3rd/4th dose (2nd PK profile), Tmax	2.5 h	Standard Deviation 2.2
9 mg/kg Q1W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 3rd/4th dose (2nd PK profile), Tmax	2.5 h	Standard Deviation 2.2
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 1st dose (1st PK profile), Tmax	0 h	Standard Deviation 0
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 1st dose (1st PK profile), Tmax	0.69 h	Standard Deviation 1.2
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 1st dose (1st PK profile), Tmax	0.69 h	Standard Deviation 1.2
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 3rd/4th dose (2nd PK profile), Tmax	0.97 h	Standard Deviation 1.4
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 1st dose (1st PK profile), Tmax	0 h	Standard Deviation 0
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 1st dose (1st PK profile), Tmax	0 h	Standard Deviation 0
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 1st dose (1st PK profile), Tmax	0.97 h	Standard Deviation 1.2
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 3rd/4th dose (2nd PK profile), Tmax	0.97 h	Standard Deviation 1.4
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 3rd/4th dose (2nd PK profile), Tmax	0.67 h	Standard Deviation 1.4
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 3rd/4th dose (2nd PK profile), Tmax	0.97 h	Standard Deviation 1.4
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 3rd/4th dose (2nd PK profile), Tmax	0.97 h	Standard Deviation 1.4
6 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 3rd/4th dose (2nd PK profile), Tmax	0.97 h	Standard Deviation 1.4
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 3rd/4th dose (2nd PK profile), Tmax	0.94 h	Standard Deviation 1
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 1st dose (1st PK profile), Tmax	1.1 h	Standard Deviation 1.2
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 1st dose (1st PK profile), Tmax	1.7 h	Standard Deviation 1.9
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 3rd/4th dose (2nd PK profile), Tmax	1.2 h	Standard Deviation 2.1
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 1st dose (1st PK profile), Tmax	1.4 h	Standard Deviation 1.3
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 3rd/4th dose (2nd PK profile), Tmax	4.0 h	Standard Deviation 8.3
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 3rd/4th dose (2nd PK profile), Tmax	0.91 h	Standard Deviation 1.5
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 1st dose (1st PK profile), Tmax	1.3 h	Standard Deviation 1.1
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 1st dose (1st PK profile), Tmax	3.1 h	Standard Deviation 5.4
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 3rd/4th dose (2nd PK profile), Tmax	0.94 h	Standard Deviation 1
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 1st dose (1st PK profile), Tmax	1.9 h	Standard Deviation 1.8
9 mg/kg Q2W	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 3rd/4th dose (2nd PK profile), Tmax	1.5 h	Standard Deviation 2
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 1st dose (1st PK profile), Tmax	1.4 h	Standard Deviation 1
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 3rd/4th dose (2nd PK profile), Tmax	1.7 h	Standard Deviation 2.4
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 3rd/4th dose (2nd PK profile), Tmax	0 h	Standard Deviation 0
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 3rd/4th dose (2nd PK profile), Tmax	0.95 h	Standard Deviation 1.3
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 3rd/4th dose (2nd PK profile), Tmax	0 h	Standard Deviation 0
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 3rd/4th dose (2nd PK profile), Tmax	0 h	Standard Deviation 0
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 1st dose (1st PK profile), Tmax	1.0 h	Standard Deviation 1.2
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 3rd/4th dose (2nd PK profile), Tmax	0 h	Standard Deviation 0
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 1st dose (1st PK profile), Tmax	1.0 h	Standard Deviation 1.1
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 1st dose (1st PK profile), Tmax	1.3 h	Standard Deviation 0.89
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 1st dose (1st PK profile), Tmax	0.91 h	Standard Deviation 1.1
9 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 1st dose (1st PK profile), Tmax	0.52 h	Standard Deviation 1
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1277, 1st dose (1st PK profile), Tmax	0.94 h	Standard Deviation 1.6
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4384, 1st dose (1st PK profile), Tmax	1.2 h	Standard Deviation 2.1
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu1565, 1st dose (1st PK profile), Tmax	2.2 h	Standard Deviation 1.9
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu4517, 1st dose (1st PK profile), Tmax	0 h	Standard Deviation 0
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5082, 1st dose (1st PK profile), Tmax	6.4 h	Standard Deviation 11
12 mg/kg Q2W + Prophylaxis	Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).	Hu5038, 1st dose (1st PK profile), Tmax	1.2 h	Standard Deviation 2.1

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026

Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Part 1: Assess the Safety and Tolerability of Sym013 When Administered Either Q1W or Q2W to Separate Dose-escalation Cohorts of Patients.

Part 2: Evaluate the Antitumor Effect of Sym013 When Administered at the RP2D and Regimen to Patients.

Part 1: Determine the RP2D and Regimen of Sym013.

Parts 1 and 2: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC).

Parts 1 and 2: Clearance (CL).

Parts 1 and 2: Elimination Half-life (T½).

Parts 1 and 2: Evaluate the Immunogenicity of Sym013.

Parts 1 and 2: Maximum Concentration (Cmax) and Trough Concentration (Ctrough) - Mean Values.

Parts 1 and 2: Time to Reach Maximum Concentration (Tmax).