Trial Outcomes & Findings for Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients (NCT NCT02000817)

NCT ID: NCT02000817

Last Updated: 2019-06-24

Results Overview

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs have been reported. Safety Population comprised of all participants who received at least one dose of study treatment.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Up to Day 14

Results posted on

2019-06-24

Participant Flow

The study was a multi-centered, single-blind, randomized, placebo-controlled 6 Day repeat dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and immunological profile of intravenously administered Otelixizumab (OTX) in New Onset Type 1 Diabetes Mellitus participants.

A total of 30 participants were enrolled at different centers in Belgium, which was conducted from 12-Mar-2014 to 27-Sep-2018.

Participant milestones

Participant milestones
Measure	Placebo Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Study STARTED	6	9	8	7
Overall Study COMPLETED	4	8	7	7
Overall Study NOT COMPLETED	2	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days
Overall Study Withdrawal by Subject	2	0	0
Overall Study Adverse Event	0	1	0
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Total n=29 Participants Total of all reporting groups
Age, Continuous	24.8 Years STANDARD_DEVIATION 4.44 • n=5 Participants	22.4 Years STANDARD_DEVIATION 2.13 • n=7 Participants	20.5 Years STANDARD_DEVIATION 4.31 • n=5 Participants	22.1 Years STANDARD_DEVIATION 3.98 • n=4 Participants	22.2 Years STANDARD_DEVIATION 3.77 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants
Race/Ethnicity, Customized WHITE	5 Count of Participants n=5 Participants	9 Count of Participants n=7 Participants	8 Count of Participants n=5 Participants	7 Count of Participants n=4 Participants	29 Count of Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to Day 14

Population: Safety population

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS)	5 Participants	9 Participants	8 Participants	7 Participants

PRIMARY outcome

Timeframe: Week 3, Week 6, Week 8, Week 12, Week 24 and Week 96

Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Blood samples were collected for analysis of EBV viral load and detection was done by polymerase chain reaction (PCR).

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Epstein-Barr Virus (EBV) Viral Load Detection Week 3, n=5, 8, 8, 7	12.0 Copies per million cells Geometric Coefficient of Variation 32806.06	438.5 Copies per million cells Geometric Coefficient of Variation 193067.66	4266.1 Copies per million cells Geometric Coefficient of Variation 306867.44	64870.6 Copies per million cells Geometric Coefficient of Variation 723.66
Epstein-Barr Virus (EBV) Viral Load Detection Week 6, n=4, 9, 8, 7	28.1 Copies per million cells Geometric Coefficient of Variation 178623.77	20.5 Copies per million cells Geometric Coefficient of Variation 77662.74	398.2 Copies per million cells Geometric Coefficient of Variation 131086.12	974.2 Copies per million cells Geometric Coefficient of Variation 19777.11
Epstein-Barr Virus (EBV) Viral Load Detection Week 8, n=5, 9, 7, 5	3.5 Copies per million cells Geometric Coefficient of Variation 4755.63	8.9 Copies per million cells Geometric Coefficient of Variation 22969.48	17.0 Copies per million cells Geometric Coefficient of Variation 55312.01	24.3 Copies per million cells Geometric Coefficient of Variation 3060948.75
Epstein-Barr Virus (EBV) Viral Load Detection Week 12, n=4, 9, 8, 6	4.7 Copies per million cells Geometric Coefficient of Variation 12491.55	15.8 Copies per million cells Geometric Coefficient of Variation 21359.16	5.5 Copies per million cells Geometric Coefficient of Variation 15292.04	33.2 Copies per million cells Geometric Coefficient of Variation 227953.09
Epstein-Barr Virus (EBV) Viral Load Detection Week 24, n=4, 9, 7, 7	1.0 Copies per million cells Geometric Coefficient of Variation 0.00	39.3 Copies per million cells Geometric Coefficient of Variation 52129.25	15.9 Copies per million cells Geometric Coefficient of Variation 39905.91	2.9 Copies per million cells Geometric Coefficient of Variation 4732.52
Epstein-Barr Virus (EBV) Viral Load Detection Week 96, n=4, 9, 7, 7	1.0 Copies per million cells Geometric Coefficient of Variation 0.00	2.3 Copies per million cells Geometric Coefficient of Variation 2166.53	3.3 Copies per million cells Geometric Coefficient of Variation 13653.67	5.9 Copies per million cells Geometric Coefficient of Variation 9925.87

PRIMARY outcome

Timeframe: Up to Month 24

Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Blood samples were collected to analyze the laboratory parameters which included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, direct bilirubin, glucose, potassium, protein, sodium, urate, urea nitrogen, basophil, eosinophil, mean corpuscular haemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), erythrocytes, haematocrit, haemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocytes.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Number of Participants With Abnormal Laboratory Results ALT, Low, n= 5, 9, 8, 7	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results ALT, High, n= 5, 9, 8, 7	2 Participants	5 Participants	6 Participants	4 Participants
Number of Participants With Abnormal Laboratory Results Albumin, Low, n= 5, 9, 8, 7	4 Participants	5 Participants	2 Participants	3 Participants
Number of Participants With Abnormal Laboratory Results Albumin, High, n= 5, 9, 8, 7	1 Participants	4 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results ALP, Low, n= 5, 9, 8, 7	3 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results ALP, High, n= 5, 9, 8, 7	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results AST, Low, n= 5, 9, 8, 7	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results AST, High, n= 5, 9, 8, 7	1 Participants	4 Participants	5 Participants	5 Participants
Number of Participants With Abnormal Laboratory Results Bilirubin, Low, n= 5, 9, 8, 7	2 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results Bilirubin, High, n= 5, 9, 8, 7	0 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Calcium, Low, n= 5, 9, 8, 7	1 Participants	5 Participants	5 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results Calcium, High, n= 5, 9, 8, 7	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Chloride, Low, n= 5, 9, 8, 7	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results Chloride, High, n= 5, 9, 8, 7	3 Participants	5 Participants	5 Participants	3 Participants
Number of Participants With Abnormal Laboratory Results Creatinine, Low, n= 5, 9, 8, 7	1 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results Creatinine, High, n= 5, 9, 8, 7	0 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Direct Bilirubin, Low, n= 1, 5, 4, 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Direct Bilirubin, High, n= 1, 5, 4, 5	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results Glucose, Low, n= 5, 9, 8, 7	4 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Glucose, High, n= 5, 9, 8, 7	2 Participants	2 Participants	1 Participants	3 Participants
Number of Participants With Abnormal Laboratory Results Potassium, Low, n= 5, 9, 8, 7	0 Participants	3 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Potassium, High, n= 5, 9, 8, 7	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Protein, Low, n= 5, 9, 8, 7	2 Participants	3 Participants	7 Participants	3 Participants
Number of Participants With Abnormal Laboratory Results Protein, High, n= 5, 9, 8, 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Sodium, Low, n= 5, 9, 8, 7	1 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Sodium, High, n= 5, 9, 8, 7	0 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Urate, Low, n= 5, 9, 8, 7	1 Participants	6 Participants	1 Participants	6 Participants
Number of Participants With Abnormal Laboratory Results Urea Nitrogen, High, n= 5, 9, 8, 7	1 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results Basophils, Low, n= 5, 9, 8, 7	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Basophils, High, n= 5, 9, 8, 7	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Eosinophils, Low, n= 5, 9, 8, 7	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results MCHC, Low, n= 5, 9, 8, 7	2 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results MCHC, High, n= 5, 9, 8, 7	1 Participants	5 Participants	4 Participants	4 Participants
Number of Participants With Abnormal Laboratory Results MCH, Low, n= 5, 9, 8, 7	0 Participants	2 Participants	4 Participants	3 Participants
Number of Participants With Abnormal Laboratory Results MCV, Low, n= 5, 9, 8, 7	0 Participants	3 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results MCV, High, n= 5, 9, 8, 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Erythrocytes, Low, n= 5, 9, 8, 7	4 Participants	6 Participants	6 Participants	4 Participants
Number of Participants With Abnormal Laboratory Results Erythrocytes, High, n= 5, 9, 8, 7	0 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Hematocrit, Low, n= 5, 9, 8, 7	4 Participants	5 Participants	7 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Hematocrit, High, n= 5, 9, 8, 7	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Hemoglobin, High, n= 5, 9, 8, 7	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Leukocytes, Low, n= 5, 9, 8, 7	0 Participants	5 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Leukocytes, High, n= 5, 9, 8, 7	3 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results Lymphocytes, Low, n= 5, 9, 8, 7	0 Participants	9 Participants	7 Participants	7 Participants
Number of Participants With Abnormal Laboratory Results Lymphocytes, High, n= 5, 9, 8, 7	1 Participants	1 Participants	2 Participants	3 Participants
Number of Participants With Abnormal Laboratory Results Monocytes, Low, n= 5, 9, 8, 7	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Monocytes, High, n= 5, 9, 8, 7	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results Neutrophils, Low, n= 5, 9, 8, 7	0 Participants	2 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Neutrophils, High, n= 5, 9, 8, 7	2 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Platelets, Low, n= 5, 9, 8, 7	0 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Platelets, High, n= 5, 9, 8, 7	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Reticulocytes, Low, n= 1, 3, 4, 4	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Reticulocytes, High, n= 1, 3, 4, 4	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results Urate, High, n= 5, 9, 8, 7	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results Urea Nitrogen, Low, n= 5, 9, 8, 7	2 Participants	5 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Laboratory Results Eosinophils, High, n= 5, 9, 8, 7	3 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Laboratory Results MCH, High, n= 5, 9, 8, 7	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Laboratory Results Hemoglobin, Low, n= 5, 9, 8, 7	5 Participants	6 Participants	5 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to Month 24

Population: Safety population

12-lead electrocardiograms (ECGs) were obtained in semi-supine position after 5 minutes rest for the participants at indicated time points to measure QTc.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) QTc Interval (Bazett's), Increase >60 millisec	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc) QTc Interval (Fridericia), Increase >60 millisec	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Month 24

Population: Safety population

Vital signs were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Vital signs included systolic, diastolic blood pressure, pulse rate and respiratory rate

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Number of Participants With Abnormal Vital Sign Results Pulse Rate, Low	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Vital Sign Results Systolic Blood Pressure, Low	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Vital Sign Results Pulse Rate, High	1 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Vital Sign Results Respiratory Rate, Low	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Sign Results Respiratory Rate, High	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Sign Results Systolic Blood Pressure, High	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Vital Sign Results Diastolic Blood Pressure, Low	2 Participants	5 Participants	4 Participants	1 Participants
Number of Participants With Abnormal Vital Sign Results Diastolic Blood Pressure, High	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose on Day 1,2,3,4,5,6 and 14; 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 16 hours post-dose on Day 1, and 1 hour post-dose on Day 6.

Population: Fully Treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Blood samples were collected at designated timepoints. Free serum Otelixizumab concentrations were calculated by linear and semi-logarithmic individual serum concentration-time profiles. Fully treated population comprised of all randomized participants who received the full 6 days of treatment based on actual exposure data. NA indicates that data could not be calculated as \>30% of samples were below the limit of quantification.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24

Population: Intent-To-Treat (ITT) treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess levels of C-peptide. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mixed meal-stimulated C-peptide AUC was calculated from area under C-peptide/time curve from time 0 to 120 minutes, using trapezoidal rule. ITT treated population comprised of all randomized participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test Month 3, n=5, 8, 8, 7	0.175 Nanomoles minute per liter Standard Deviation 0.0797	0.255 Nanomoles minute per liter Standard Deviation 0.2852	0.118 Nanomoles minute per liter Standard Deviation 0.2462	0.153 Nanomoles minute per liter Standard Deviation 0.1312
Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test Month 6, n=5, 8, 8, 7	0.118 Nanomoles minute per liter Standard Deviation 0.0895	0.147 Nanomoles minute per liter Standard Deviation 0.3215	-0.185 Nanomoles minute per liter Standard Deviation 0.2148	0.076 Nanomoles minute per liter Standard Deviation 0.2788
Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test Month 12, n=5, 8, 8, 7	-0.103 Nanomoles minute per liter Standard Deviation 0.0552	0.023 Nanomoles minute per liter Standard Deviation 0.3145	-0.215 Nanomoles minute per liter Standard Deviation 0.2597	-0.016 Nanomoles minute per liter Standard Deviation 0.3689
Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test Month 18, n=5, 8, 7, 7	-0.278 Nanomoles minute per liter Standard Deviation 0.1142	0.015 Nanomoles minute per liter Standard Deviation 0.3903	-0.295 Nanomoles minute per liter Standard Deviation 0.3105	-0.201 Nanomoles minute per liter Standard Deviation 0.3132
Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test Month 24, n=4, 7, 7, 7	-0.296 Nanomoles minute per liter Standard Deviation 0.0962	-0.042 Nanomoles minute per liter Standard Deviation 0.2905	-0.349 Nanomoles minute per liter Standard Deviation 0.3917	-0.165 Nanomoles minute per liter Standard Deviation 0.3729

SECONDARY outcome

Timeframe: Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24

Population: ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess levels of glucose. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mixed meal-stimulated glucose was calculated from area under the glucose /time curve from time 0 to 120 minutes, using trapezoidal rule.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test Month 3, n=5, 8, 8, 7	1.382 Millmoles minute per liter Standard Deviation 1.5801	-0.550 Millmoles minute per liter Standard Deviation 1.7140	0.999 Millmoles minute per liter Standard Deviation 3.3953	0.641 Millmoles minute per liter Standard Deviation 3.0009
Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test Month 6, n=5, 8, 8, 7	1.423 Millmoles minute per liter Standard Deviation 2.9999	-1.041 Millmoles minute per liter Standard Deviation 1.5506	0.643 Millmoles minute per liter Standard Deviation 4.1751	0.749 Millmoles minute per liter Standard Deviation 2.7698
Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test Month 12, n=5, 8, 8, 7	2.314 Millmoles minute per liter Standard Deviation 2.2718	0.067 Millmoles minute per liter Standard Deviation 2.0492	1.875 Millmoles minute per liter Standard Deviation 2.7440	1.842 Millmoles minute per liter Standard Deviation 3.2408
Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test Month 18, n=5, 8, 7, 7	3.142 Millmoles minute per liter Standard Deviation 3.2172	1.159 Millmoles minute per liter Standard Deviation 2.4073	2.676 Millmoles minute per liter Standard Deviation 3.0803	3.942 Millmoles minute per liter Standard Deviation 1.9745
Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test Month 24, n=4, 7, 7, 7	4.029 Millmoles minute per liter Standard Deviation 1.2365	-1.807 Millmoles minute per liter Standard Deviation 2.1615	2.557 Millmoles minute per liter Standard Deviation 3.9428	3.435 Millmoles minute per liter Standard Deviation 2.3714

SECONDARY outcome

Timeframe: Baseline (Day-1), Month 6, Month 24

Population: ITT treated population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess levels of C-peptide during hyperglycemic (H) phase. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from specified time point value. C-peptide AUC was calculated from area under C-peptide/time curve from time H60 to H140 minutes.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test Month 6, n=5, 8, 8, 7	-0.037 Nanomoles minute per liter Standard Deviation 0.2107	0.105 Nanomoles minute per liter Standard Deviation 0.2520	-0.201 Nanomoles minute per liter Standard Deviation 0.2643	0.006 Nanomoles minute per liter Standard Deviation 0.3011
Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test Month 24, n=4, 5, 7, 7	-0.423 Nanomoles minute per liter Standard Deviation 0.1630	-0.273 Nanomoles minute per liter Standard Deviation 0.1552	-0.373 Nanomoles minute per liter Standard Deviation 0.2308	-0.344 Nanomoles minute per liter Standard Deviation 0.3397

SECONDARY outcome

Timeframe: Baseline (Day-1), Month 6 and Month 24

Population: ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to assess levels of glucose during hyperglycemic (H) phase. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Glucose AUC was calculated from area under the C-peptide/time curve from time H60 to H140 minutes.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test Month 6, n=5, 8, 8, 7	0.645 Millmoles minute per liter Standard Deviation 1.0094	0.415 Millmoles minute per liter Standard Deviation 1.3255	0.723 Millmoles minute per liter Standard Deviation 1.5955	1.074 Millmoles minute per liter Standard Deviation 0.6264
Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test Month 24, n=4, 5, 7, 7	1.346 Millmoles minute per liter Standard Deviation 1.1063	-0.501 Millmoles minute per liter Standard Deviation 3.2542	0.094 Millmoles minute per liter Standard Deviation 2.2642	1.095 Millmoles minute per liter Standard Deviation 1.3972

SECONDARY outcome

Timeframe: Baseline (Day-1), Month 6, Month 24

Population: ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Insulin sensitivity index is defined as the ratio of glucose metabolized and average insulin concentration multiplied by 100 by hyperglycemic clamp test. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test Month 6, n=5, 8, 7, 6	-0.0003 (100mmoll)/(pmolkgmin) Standard Deviation 0.00130	-0.0000 (100mmoll)/(pmolkgmin) Standard Deviation 0.00030	-0.0002 (100mmoll)/(pmolkgmin) Standard Deviation 0.00197	-0.0002 (100mmoll)/(pmolkgmin) Standard Deviation 0.00066
Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test Month 24, n=4, 4, 6, 6	0.0037 (100mmoll)/(pmolkgmin) Standard Deviation 0.00591	-0.0006 (100mmoll)/(pmolkgmin) Standard Deviation 0.00344	-0.0013 (100mmoll)/(pmolkgmin) Standard Deviation 0.01299	0.0023 (100mmoll)/(pmolkgmin) Standard Deviation 0.00351

SECONDARY outcome

Timeframe: Baseline (Day-1), Week 2, Week 3, Week 6, Week 8, Week 12, Week 24, Week 36, Week 48, Week 72 and Week 96

Population: ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Participants were asked to record their daily insulin usage thoroughly and accurately in a diary from 7 days prior to study visit. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in Mean Daily Insulin Use Week 2, n=5, 8, 7, 6	-0.0901 International unit Standard Deviation 0.05997	-0.0265 International unit Standard Deviation 0.07580	0.0941 International unit Standard Deviation 0.12919	-0.0741 International unit Standard Deviation 0.08855
Change From Baseline in Mean Daily Insulin Use Week 3, n=5, 8, 8, 7	-0.1504 International unit Standard Deviation 0.06424	-0.0424 International unit Standard Deviation 0.08708	0.0706 International unit Standard Deviation 0.14989	-0.0440 International unit Standard Deviation 0.08753
Change From Baseline in Mean Daily Insulin Use Week 6, n=5, 4, 8, 7	-0.1727 International unit Standard Deviation 0.05431	-0.1009 International unit Standard Deviation 0.12893	-0.0332 International unit Standard Deviation 0.19098	-0.1090 International unit Standard Deviation 0.11777
Change From Baseline in Mean Daily Insulin Use Week 8, n=4, 7, 5, 6	-0.1566 International unit Standard Deviation 0.07033	-0.1514 International unit Standard Deviation 0.15364	-0.0666 International unit Standard Deviation 0.21066	-0.1492 International unit Standard Deviation 0.14713
Change From Baseline in Mean Daily Insulin Use Week 12, n=4, 8, 8, 7	-0.1850 International unit Standard Deviation 0.08007	-0.1629 International unit Standard Deviation 0.14706	-0.1115 International unit Standard Deviation 0.16950	-0.1850 International unit Standard Deviation 0.20173
Change From Baseline in Mean Daily Insulin Use Week 24, n=5, 8, 5, 7	-0.1449 International unit Standard Deviation 0.09069	-0.1168 International unit Standard Deviation 0.20181	0.0298 International unit Standard Deviation 0.13942	-0.1678 International unit Standard Deviation 0.17308
Change From Baseline in Mean Daily Insulin Use Week 36, n=4, 8, 7, 7	-0.0776 International unit Standard Deviation 0.13492	-0.0673 International unit Standard Deviation 0.26527	0.0701 International unit Standard Deviation 0.20840	-0.1114 International unit Standard Deviation 0.21943
Change From Baseline in Mean Daily Insulin Use Week 48, n=5, 8, 8, 7	-0.1221 International unit Standard Deviation 0.16778	-0.0936 International unit Standard Deviation 0.24246	0.0970 International unit Standard Deviation 0.15473	-0.1155 International unit Standard Deviation 0.25461
Change From Baseline in Mean Daily Insulin Use Week 72, n=5, 8, 7, 5	-0.1000 International unit Standard Deviation 0.23378	0.0172 International unit Standard Deviation 0.43320	0.1088 International unit Standard Deviation 0.07406	0.0807 International unit Standard Deviation 0.27375
Change From Baseline in Mean Daily Insulin Use Week 96, n=4, 6, 7, 7	-0.0390 International unit Standard Deviation 0.34885	-0.0811 International unit Standard Deviation 0.34104	0.1131 International unit Standard Deviation 0.16596	0.1117 International unit Standard Deviation 0.19080

SECONDARY outcome

Timeframe: Baseline (Day-1), Month 6, Month 12 and Month 24

Population: ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Hemoglobin A1C levels were measured at indicated time points. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in Hemoglobin A1c Month 6, n=5, 8, 8, 7	-3.26 Percentage of HbA1c Standard Deviation 1.119	-2.29 Percentage of HbA1c Standard Deviation 1.883	-0.68 Percentage of HbA1c Standard Deviation 2.437	-2.04 Percentage of HbA1c Standard Deviation 2.141
Change From Baseline in Hemoglobin A1c Month 12, n=5, 9, 8, 7	-3.26 Percentage of HbA1c Standard Deviation 1.665	-2.10 Percentage of HbA1c Standard Deviation 2.125	-1.15 Percentage of HbA1c Standard Deviation 1.384	-1.60 Percentage of HbA1c Standard Deviation 2.985
Change From Baseline in Hemoglobin A1c Month 24, n=4, 9, 7, 7	-2.53 Percentage of HbA1c Standard Deviation 2.445	-2.23 Percentage of HbA1c Standard Deviation 1.736	-0.33 Percentage of HbA1c Standard Deviation 2.075	-1.41 Percentage of HbA1c Standard Deviation 2.174

SECONDARY outcome

Timeframe: Day-1, Month 12, Month 18 and Month 24

Population: ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Body weight was measured at indicated time points.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Absolute Body Weight Day -1, n=5, 9, 8, 7	65.22 Kilogram Standard Deviation 10.608	72.84 Kilogram Standard Deviation 16.118	64.19 Kilogram Standard Deviation 9.545	65.27 Kilogram Standard Deviation 8.714
Absolute Body Weight Month 12, n=5, 9, 8, 7	70.24 Kilogram Standard Deviation 12.691	75.86 Kilogram Standard Deviation 15.503	64.58 Kilogram Standard Deviation 9.851	67.96 Kilogram Standard Deviation 8.373
Absolute Body Weight Month 18, n=5, 9, 7, 7	70.44 Kilogram Standard Deviation 13.209	75.22 Kilogram Standard Deviation 16.504	63.56 Kilogram Standard Deviation 8.658	68.97 Kilogram Standard Deviation 10.167
Absolute Body Weight Month 24, n=4, 9, 7, 7	66.98 Kilogram Standard Deviation 11.226	75.82 Kilogram Standard Deviation 17.507	63.71 Kilogram Standard Deviation 8.037	69.79 Kilogram Standard Deviation 8.689

SECONDARY outcome

Timeframe: Up to Month 24

Population: ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

As per American Diabetes Association (ADA), hypoglycemia is defined as blood glucose level \<= 70 milligram/deciliter (mg/dl) and hyperglycemia is defined as blood glucose level \> 250 mg/dL. Hypoglycaemic and hyperglycaemic events will be recorded in a diary whenever they occur, along with the start and stop dates. Mean number of events is defined as the average number of events reported per subject. Normalization is expressed by dividing number of events by length of reporting period in month (1 month = 30 days).

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=7 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Time-normalized Number of Hypoglycemic and Hyperglycemic Events Hypoglycemia	14.13 Number of events Standard Deviation 3.533	21.45 Number of events Standard Deviation 2.383	7.74 Number of events Standard Deviation 1.105	24.55 Number of events Standard Deviation 3.508
Time-normalized Number of Hypoglycemic and Hyperglycemic Events Hyperglycemia	2.79 Number of events Standard Deviation 0.698	11.03 Number of events Standard Deviation 1.225	14.13 Number of events Standard Deviation 2.019	8.48 Number of events Standard Deviation 1.211

SECONDARY outcome

Timeframe: Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14

Population: Fully treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Whole blood samples were collected and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Relative change from Baseline (percentage) was calculated as change from Baseline relative to Baseline in percentage.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 4, n=5, 7, 8, 6	-2.2685 Percentage Standard Deviation 9.15020	48.5169 Percentage Standard Deviation 11.02802	82.0325 Percentage Standard Deviation 10.26798	91.6139 Percentage Standard Deviation 1.52341
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 1, 6 hours, n=5, 7, 8, 6	3.3922 Percentage Standard Deviation 6.75373	58.4446 Percentage Standard Deviation 9.17750	70.8026 Percentage Standard Deviation 8.26487	67.9378 Percentage Standard Deviation 25.45192
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 1, 8 hours, n=5, 7, 7, 6	6.9714 Percentage Standard Deviation 8.64363	58.4772 Percentage Standard Deviation 9.97693	76.5366 Percentage Standard Deviation 12.00112	69.8593 Percentage Standard Deviation 23.77517
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 1, 9 hours, n=1, 6, 0, 0	18.8383 Percentage Standard Deviation NA NA indicates that standard deviation could not be calculated for a single participant.	58.2218 Percentage Standard Deviation 11.84589	—	—
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 1, 12 hours, n=4, 0, 7, 6	1.1168 Percentage Standard Deviation 9.94441	—	72.0336 Percentage Standard Deviation 10.97106	72.4138 Percentage Standard Deviation 28.39518
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 1, 16 hours, n=4, 6, 8, 6	-1.9654 Percentage Standard Deviation 4.50998	47.1603 Percentage Standard Deviation 7.15517	79.1078 Percentage Standard Deviation 8.03676	75.8997 Percentage Standard Deviation 24.65609
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 2, n=5, 7, 8, 6	5.8586 Percentage Standard Deviation 11.64080	38.9846 Percentage Standard Deviation 10.09414	67.5197 Percentage Standard Deviation 8.13498	71.3820 Percentage Standard Deviation 20.92599
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 3, n=5, 7, 8, 6	8.4017 Percentage Standard Deviation 21.57257	47.8814 Percentage Standard Deviation 8.46678	77.5903 Percentage Standard Deviation 8.78800	88.1872 Percentage Standard Deviation 3.79283
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 1, 30 minutes, n=5, 7, 8, 6	-2.2331 Percentage Standard Deviation 8.06090	15.7568 Percentage Standard Deviation 9.45733	22.3101 Percentage Standard Deviation 11.38275	37.9286 Percentage Standard Deviation 7.06740
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 1, 1 hour, n=5, 7, 8, 6	-0.9229 Percentage Standard Deviation 3.79426	24.8673 Percentage Standard Deviation 8.97161	33.2356 Percentage Standard Deviation 10.06318	40.8432 Percentage Standard Deviation 17.12371
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 1, 2 hours, n=5, 7, 8, 6	4.6329 Percentage Standard Deviation 10.59418	32.0976 Percentage Standard Deviation 13.50078	42.2579 Percentage Standard Deviation 11.17916	54.2045 Percentage Standard Deviation 9.65956
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 1, 4 hours, n=5, 7, 8, 6	-1.8509 Percentage Standard Deviation 9.27472	31.4853 Percentage Standard Deviation 18.78336	49.3861 Percentage Standard Deviation 14.33838	49.1721 Percentage Standard Deviation 30.22147
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 5, n=5, 7, 8, 6	9.4816 Percentage Standard Deviation 10.25461	64.5703 Percentage Standard Deviation 8.16040	88.1950 Percentage Standard Deviation 6.33948	94.2542 Percentage Standard Deviation 1.59484
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 6, n=5, 7, 8, 6	4.6145 Percentage Standard Deviation 5.61446	70.6624 Percentage Standard Deviation 7.58163	89.9853 Percentage Standard Deviation 4.21710	95.1333 Percentage Standard Deviation 1.79263
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 6, 1 hour, n=5, 7, 8, 6	8.0058 Percentage Standard Deviation 7.53027	93.5215 Percentage Standard Deviation 2.42406	91.9917 Percentage Standard Deviation 2.78804	95.3978 Percentage Standard Deviation 1.70448
Relative Change From Baseline in Percentage (%) in CD4+ Cells Day 14, n=5, 6, 8, 4	16.0448 Percentage Standard Deviation 15.71866	18.3627 Percentage Standard Deviation 15.59835	17.6415 Percentage Standard Deviation 27.54591	38.7962 Percentage Standard Deviation 17.92367

SECONDARY outcome

Timeframe: Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14

Population: Fully treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Whole blood samples were collected and analyzed by flow cytometry. Day1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Relative change from baseline (%) was calculated as change from Baseline relative to Baseline in %. NA indicates that standard deviation could not be calculated for a single participant.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 1, 6 hours, n=5, 7, 8, 6	5.2570 Percentage Standard Deviation 5.13603	50.6248 Percentage Standard Deviation 8.12251	63.2777 Percentage Standard Deviation 9.16749	61.0355 Percentage Standard Deviation 22.44049
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 1, 8 hours, n=5, 7, 7, 6	3.0516 Percentage Standard Deviation 5.05296	50.0586 Percentage Standard Deviation 13.15793	64.0559 Percentage Standard Deviation 8.96743	64.6389 Percentage Standard Deviation 23.37406
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 1, 9 hours, n=1, 6, 0, 0	12.0124 Percentage Standard Deviation NA NA indicates that standard deviation could not be calculated for a single participant.	47.3877 Percentage Standard Deviation 10.18779	—	—
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 1, 16 hours, n=4, 6, 8, 6	2.4031 Percentage Standard Deviation 9.29601	36.5804 Percentage Standard Deviation 11.00323	73.7619 Percentage Standard Deviation 9.27676	73.7870 Percentage Standard Deviation 23.65616
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 2, n=5, 7, 8, 6	11.5153 Percentage Standard Deviation 12.44266	32.3389 Percentage Standard Deviation 17.53306	63.2076 Percentage Standard Deviation 11.90764	68.8582 Percentage Standard Deviation 23.13445
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 3, n=5, 7, 8, 6	9.6580 Percentage Standard Deviation 17.96579	38.6763 Percentage Standard Deviation 10.50068	73.4518 Percentage Standard Deviation 13.11370	86.3391 Percentage Standard Deviation 4.07679
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 1, 12 hours, n=4, 0, 7, 6	4.6297 Percentage Standard Deviation 1.55778	—	63.0325 Percentage Standard Deviation 11.60295	68.2523 Percentage Standard Deviation 25.41788
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 1, 4 hours, n=5, 7, 8, 6	2.4574 Percentage Standard Deviation 5.34591	27.9312 Percentage Standard Deviation 15.06025	40.2754 Percentage Standard Deviation 12.70208	41.5574 Percentage Standard Deviation 26.91586
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 1, 2 hours, n=5, 7, 8, 6	5.7591 Percentage Standard Deviation 7.62243	29.7916 Percentage Standard Deviation 10.08248	36.7030 Percentage Standard Deviation 11.18167	48.2854 Percentage Standard Deviation 10.33624
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 4, n=5, 7, 8, 6	1.4965 Percentage Standard Deviation 9.56563	39.4735 Percentage Standard Deviation 13.72429	78.2797 Percentage Standard Deviation 13.97813	89.7661 Percentage Standard Deviation 2.38427
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 5, n=5, 7, 8, 6	13.1690 Percentage Standard Deviation 10.31403	55.7138 Percentage Standard Deviation 7.92647	84.6850 Percentage Standard Deviation 10.08105	92.6561 Percentage Standard Deviation 1.66146
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 6, n=5, 7, 8, 6	9.5352 Percentage Standard Deviation 4.64977	62.6915 Percentage Standard Deviation 6.12617	87.5358 Percentage Standard Deviation 6.72558	93.6820 Percentage Standard Deviation 1.51640
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 6, 1 hour, n=5, 7, 8, 6	9.6315 Percentage Standard Deviation 7.30255	90.8426 Percentage Standard Deviation 2.43623	91.3298 Percentage Standard Deviation 3.00883	93.9939 Percentage Standard Deviation 1.50147
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 1, 30 minutes, n=5, 7, 8, 6	1.4489 Percentage Standard Deviation 5.86548	13.6045 Percentage Standard Deviation 6.84553	18.4972 Percentage Standard Deviation 10.57226	35.6721 Percentage Standard Deviation 7.81791
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 1, 1 hour, n=5, 7, 8, 6	3.9227 Percentage Standard Deviation 3.52082	23.2571 Percentage Standard Deviation 8.77440	29.9262 Percentage Standard Deviation 9.11960	37.1052 Percentage Standard Deviation 15.47566
Relative Change From Baseline in Percentage (%) in CD8+ Cells Day 14, n=5, 6, 8, 4	21.2448 Percentage Standard Deviation 18.40147	19.6382 Percentage Standard Deviation 18.17904	20.1594 Percentage Standard Deviation 27.60057	33.4359 Percentage Standard Deviation 23.03254

SECONDARY outcome

Timeframe: Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14

Population: Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in Free CD3 on CD8+ Cells Day 1, 8 hours, n=5, 7, 7, 6	-5118.8 Copies per cell Standard Deviation 9260.84	-64346.1 Copies per cell Standard Deviation 16499.07	-113884.9 Copies per cell Standard Deviation 36548.70	-79778.2 Copies per cell Standard Deviation 25001.56
Change From Baseline in Free CD3 on CD8+ Cells Day 6, 1 hour, n=5, 7, 8, 6	-14414.4 Copies per cell Standard Deviation 10131.25	-118000.6 Copies per cell Standard Deviation 18946.75	-155565.6 Copies per cell Standard Deviation 29776.06	-122237.2 Copies per cell Standard Deviation 22786.52
Change From Baseline in Free CD3 on CD8+ Cells Day 14, n=5, 6, 8, 4	-30658.2 Copies per cell Standard Deviation 25814.70	-25656.7 Copies per cell Standard Deviation 23202.59	-34478.6 Copies per cell Standard Deviation 46509.48	-49846.8 Copies per cell Standard Deviation 42800.88
Change From Baseline in Free CD3 on CD8+ Cells Day 1, 30 minutes, n=5, 7, 8, 6	-1570.2 Copies per cell Standard Deviation 7996.97	-17344.6 Copies per cell Standard Deviation 8219.24	-33177.1 Copies per cell Standard Deviation 26046.74	-46590.5 Copies per cell Standard Deviation 14242.51
Change From Baseline in Free CD3 on CD8+ Cells Day 1, 1 hour, n=5, 7, 8, 6	-5367.8 Copies per cell Standard Deviation 4454.93	-30170.0 Copies per cell Standard Deviation 11702.96	-52164.3 Copies per cell Standard Deviation 25780.68	-45971.2 Copies per cell Standard Deviation 17371.50
Change From Baseline in Free CD3 on CD8+ Cells Day 1, 2 hours, n=5, 7, 8, 6	-7599.6 Copies per cell Standard Deviation 9683.28	-38063.3 Copies per cell Standard Deviation 12268.28	-64195.5 Copies per cell Standard Deviation 30475.25	-63303.5 Copies per cell Standard Deviation 19743.02
Change From Baseline in Free CD3 on CD8+ Cells Day 1, 4 hours, n=5, 7, 8, 6	-2668.2 Copies per cell Standard Deviation 7081.48	-37523.3 Copies per cell Standard Deviation 21827.29	-70708.9 Copies per cell Standard Deviation 35060.26	-50216.3 Copies per cell Standard Deviation 33433.24
Change From Baseline in Free CD3 on CD8+ Cells Day 1, 6 hours, n=5, 7, 8, 6	-7434.0 Copies per cell Standard Deviation 6566.98	-65821.7 Copies per cell Standard Deviation 14778.18	-109702.0 Copies per cell Standard Deviation 36004.22	-75299.7 Copies per cell Standard Deviation 24515.25
Change From Baseline in Free CD3 on CD8+ Cells Day 1, 9 hours, n=1, 6, 0, 0	-14630.0 Copies per cell Standard Deviation NA NA indicates that standard deviation could not be calculated for a single participant.	-62113.7 Copies per cell Standard Deviation 17114.28	—	—
Change From Baseline in Free CD3 on CD8+ Cells Day 1, 12 hours, n=4, 0, 7, 6	-7671.0 Copies per cell Standard Deviation 3453.02	—	-111484.0 Copies per cell Standard Deviation 37822.49	-84085.8 Copies per cell Standard Deviation 27533.48
Change From Baseline in Free CD3 on CD8+ Cells Day 1, 16 hours, n=4, 6, 8, 6	-2398.0 Copies per cell Standard Deviation 12735.14	-48607.8 Copies per cell Standard Deviation 17774.03	-126378.6 Copies per cell Standard Deviation 34284.38	-91537.5 Copies per cell Standard Deviation 23378.53
Change From Baseline in Free CD3 on CD8+ Cells Day 2, n=5, 7, 8, 6	-16282.6 Copies per cell Standard Deviation 18931.53	-42379.1 Copies per cell Standard Deviation 25223.07	-108857.0 Copies per cell Standard Deviation 36292.51	-85611.5 Copies per cell Standard Deviation 24571.30
Change From Baseline in Free CD3 on CD8+ Cells Day 3, n=5, 7, 8, 6	-12613.4 Copies per cell Standard Deviation 23082.56	-50757.1 Copies per cell Standard Deviation 16662.32	-126037.9 Copies per cell Standard Deviation 39171.31	-112220.0 Copies per cell Standard Deviation 20740.64
Change From Baseline in Free CD3 on CD8+ Cells Day 4, n=5, 7, 8, 6	-2479.6 Copies per cell Standard Deviation 14120.73	-52064.6 Copies per cell Standard Deviation 22177.41	-133794.1 Copies per cell Standard Deviation 38684.37	-116816.5 Copies per cell Standard Deviation 22469.30
Change From Baseline in Free CD3 on CD8+ Cells Day 5, n=5, 7, 8, 6	-19504.4 Copies per cell Standard Deviation 14161.40	-72058.3 Copies per cell Standard Deviation 13158.75	-144613.4 Copies per cell Standard Deviation 35791.57	-120512.7 Copies per cell Standard Deviation 22578.38
Change From Baseline in Free CD3 on CD8+ Cells Day 6, n=5, 7, 8, 6	-13905.4 Copies per cell Standard Deviation 6365.89	-81326.7 Copies per cell Standard Deviation 14410.25	-149202.1 Copies per cell Standard Deviation 32099.88	-121836.0 Copies per cell Standard Deviation 22706.98

SECONDARY outcome

Timeframe: Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14

Population: Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in Free CD3 on CD4+ Cells Day 1, 30 minutes, n=5, 7, 8, 6	5529.0 Copies per cell Standard Deviation 13037.93	-26310.0 Copies per cell Standard Deviation 15691.77	-46612.6 Copies per cell Standard Deviation 31524.47	-61053.8 Copies per cell Standard Deviation 16266.15
Change From Baseline in Free CD3 on CD4+ Cells Day 1, 1 hour, n=5, 7, 8, 6	2819.2 Copies per cell Standard Deviation 8108.55	-41955.9 Copies per cell Standard Deviation 16287.89	-68726.5 Copies per cell Standard Deviation 33738.60	-63524.8 Copies per cell Standard Deviation 26817.94
Change From Baseline in Free CD3 on CD4+ Cells Day 1, 4 hours, n=5, 7, 8, 6	2651.6 Copies per cell Standard Deviation 14138.56	-54076.3 Copies per cell Standard Deviation 34638.82	-101829.5 Copies per cell Standard Deviation 45896.19	-73042.7 Copies per cell Standard Deviation 45129.43
Change From Baseline in Free CD3 on CD4+ Cells Day 1, 6 hours, n=5, 7, 8, 6	-5072.0 Copies per cell Standard Deviation 11737.82	-97871.0 Copies per cell Standard Deviation 18824.51	-143635.8 Copies per cell Standard Deviation 41952.00	-104097.7 Copies per cell Standard Deviation 36063.45
Change From Baseline in Free CD3 on CD4+ Cells Day 1, 12 hours, n=4, 0, 7, 6	-4958.5 Copies per cell Standard Deviation 15637.79	—	-150231.0 Copies per cell Standard Deviation 46611.02	-111627.8 Copies per cell Standard Deviation 43965.70
Change From Baseline in Free CD3 on CD4+ Cells Day 1, 16 hours, n=4, 6, 8, 6	4546.3 Copies per cell Standard Deviation 7628.46	-79792.2 Copies per cell Standard Deviation 16063.80	-159376.9 Copies per cell Standard Deviation 40492.21	-117485.2 Copies per cell Standard Deviation 35848.96
Change From Baseline in Free CD3 on CD4+ Cells Day 2, n=5, 7, 8, 6	-9071.4 Copies per cell Standard Deviation 22730.36	-64674.3 Copies per cell Standard Deviation 14881.25	-136989.0 Copies per cell Standard Deviation 40208.17	-111246.8 Copies per cell Standard Deviation 30955.42
Change From Baseline in Free CD3 on CD4+ Cells Day 3, n=5, 7, 8, 6	-9750.2 Copies per cell Standard Deviation 28173.66	-80703.6 Copies per cell Standard Deviation 19670.68	-156782.3 Copies per cell Standard Deviation 42746.51	-141892.0 Copies per cell Standard Deviation 28600.19
Change From Baseline in Free CD3 on CD4+ Cells Day 4, n=5, 7, 8, 6	4442.8 Copies per cell Standard Deviation 16258.54	-81174.3 Copies per cell Standard Deviation 21094.09	-165042.3 Copies per cell Standard Deviation 42878.04	-147344.5 Copies per cell Standard Deviation 28442.20
Change From Baseline in Free CD3 on CD4+ Cells Day 5, n=5, 7, 8, 6	-14696.4 Copies per cell Standard Deviation 15969.14	-107817.7 Copies per cell Standard Deviation 16112.46	-177310.9 Copies per cell Standard Deviation 40876.20	-151768.5 Copies per cell Standard Deviation 30266.62
Change From Baseline in Free CD3 on CD4+ Cells Day 14, n=5, 6, 8, 4	-25564.4 Copies per cell Standard Deviation 24902.78	-31243.3 Copies per cell Standard Deviation 25714.52	-37536.4 Copies per cell Standard Deviation 55570.83	-70890.5 Copies per cell Standard Deviation 40581.96
Change From Baseline in Free CD3 on CD4+ Cells Day 1, 2 hours, n=5, 7, 8, 6	-5833.0 Copies per cell Standard Deviation 17972.31	-54111.1 Copies per cell Standard Deviation 23197.46	-86880.5 Copies per cell Standard Deviation 37961.85	-87013.2 Copies per cell Standard Deviation 20852.00
Change From Baseline in Free CD3 on CD4+ Cells Day 1, 8 hours, n=5, 7, 7, 6	-10668.4 Copies per cell Standard Deviation 11325.47	-97642.4 Copies per cell Standard Deviation 17931.01	-156878.1 Copies per cell Standard Deviation 38450.32	-107788.0 Copies per cell Standard Deviation 34304.89
Change From Baseline in Free CD3 on CD4+ Cells Day 1, 9 hours, n=1, 6, 0, 0	-31435.0 Copies per cell Standard Deviation NA NA indicates that standard deviation could not be calculated for a single participant.	-98963.5 Copies per cell Standard Deviation 25253.18	—	—
Change From Baseline in Free CD3 on CD4+ Cells Day 6, n=5, 7, 8, 6	-7848.0 Copies per cell Standard Deviation 10416.76	-118246.4 Copies per cell Standard Deviation 17896.58	-180424.5 Copies per cell Standard Deviation 37325.84	-153238.7 Copies per cell Standard Deviation 30828.00
Change From Baseline in Free CD3 on CD4+ Cells Day 6, 1 hour, n=5, 7, 8, 6	-12708.6 Copies per cell Standard Deviation 8424.98	-156241.0 Copies per cell Standard Deviation 14748.58	-184362.0 Copies per cell Standard Deviation 36070.44	-153638.3 Copies per cell Standard Deviation 30779.71

SECONDARY outcome

Timeframe: Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14

Population: Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 1, 8 hours, n=5, 7, 7, 6	13.6 Copies per cell Standard Deviation 203.64	86801.1 Copies per cell Standard Deviation 24642.24	60435.0 Copies per cell Standard Deviation 24147.90	51092.2 Copies per cell Standard Deviation 25386.18
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 1, 9 hours, n=1, 6, 0, 0	-36.0 Copies per cell Standard Deviation NA NA indicates that standard deviation could not be calculated for a single participant.	55085.3 Copies per cell Standard Deviation 14474.39	—	—
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 1, 12 hours, n=4, 0, 7, 6	-2.8 Copies per cell Standard Deviation 188.70	—	57280.0 Copies per cell Standard Deviation 7920.20	34176.7 Copies per cell Standard Deviation 22339.84
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 2, n=5, 7, 8, 6	-120.8 Copies per cell Standard Deviation 157.70	14676.3 Copies per cell Standard Deviation 4819.20	27994.6 Copies per cell Standard Deviation 7683.11	23777.3 Copies per cell Standard Deviation 10220.98
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 3, n=5, 7, 8, 6	-56.4 Copies per cell Standard Deviation 209.56	15982.6 Copies per cell Standard Deviation 5415.43	23383.9 Copies per cell Standard Deviation 7380.09	19095.8 Copies per cell Standard Deviation 4142.74
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 4, n=5, 7, 8, 6	-199.0 Copies per cell Standard Deviation 221.61	12522.1 Copies per cell Standard Deviation 4472.75	17241.8 Copies per cell Standard Deviation 3135.36	14843.3 Copies per cell Standard Deviation 3645.33
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 5, n=5, 7, 8, 6	-31.4 Copies per cell Standard Deviation 334.36	9679.6 Copies per cell Standard Deviation 3432.37	5748.1 Copies per cell Standard Deviation 2499.44	6979.3 Copies per cell Standard Deviation 4026.59
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 6, n=5, 7, 8, 6	-103.4 Copies per cell Standard Deviation 138.02	4856.7 Copies per cell Standard Deviation 4683.55	3671.9 Copies per cell Standard Deviation 1663.91	4700.3 Copies per cell Standard Deviation 2723.61
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 6, 1 hour, n=5, 7, 8, 6	-22.2 Copies per cell Standard Deviation 385.45	15972.9 Copies per cell Standard Deviation 4968.41	4262.9 Copies per cell Standard Deviation 2221.09	4658.3 Copies per cell Standard Deviation 2789.87
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 14, n=5, 6, 8, 4	-111.2 Copies per cell Standard Deviation 227.74	-874.7 Copies per cell Standard Deviation 2068.49	688.0 Copies per cell Standard Deviation 513.77	1506.3 Copies per cell Standard Deviation 2330.70
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 1, 30 minutes, n=5, 7, 8, 6	-54.0 Copies per cell Standard Deviation 103.13	29059.1 Copies per cell Standard Deviation 15150.15	27538.5 Copies per cell Standard Deviation 12441.29	28035.7 Copies per cell Standard Deviation 14672.79
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 1, 1 hour, n=5, 7, 8, 6	-10.2 Copies per cell Standard Deviation 82.62	39472.3 Copies per cell Standard Deviation 16401.81	43911.8 Copies per cell Standard Deviation 14701.05	38406.5 Copies per cell Standard Deviation 19297.11
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 1, 2 hours, n=5, 7, 8, 6	27.6 Copies per cell Standard Deviation 133.59	54116.3 Copies per cell Standard Deviation 14159.80	56840.6 Copies per cell Standard Deviation 15756.66	47028.2 Copies per cell Standard Deviation 24507.94
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 1, 4 hours, n=5, 7, 8, 6	-50.4 Copies per cell Standard Deviation 113.62	62635.7 Copies per cell Standard Deviation 24380.73	54693.1 Copies per cell Standard Deviation 16678.89	42730.2 Copies per cell Standard Deviation 24609.04
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 1, 6 hours, n=5, 7, 8, 6	-77.4 Copies per cell Standard Deviation 168.73	86518.1 Copies per cell Standard Deviation 23953.89	74664.6 Copies per cell Standard Deviation 5837.58	49078.8 Copies per cell Standard Deviation 27502.89
Change From Baseline in Bound CD3 Copies on CD4+ Cells Day 1, 16 hours, n=4, 6, 8, 6	62.3 Copies per cell Standard Deviation 278.48	33286.2 Copies per cell Standard Deviation 10303.10	46080.4 Copies per cell Standard Deviation 7254.50	28515.0 Copies per cell Standard Deviation 13537.67

SECONDARY outcome

Timeframe: Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14

Population: Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 1, 2 hours, n=5, 7, 8, 6	101.2 Copies per cell Standard Deviation 265.29	35963.7 Copies per cell Standard Deviation 6942.11	42469.1 Copies per cell Standard Deviation 13977.93	38510.7 Copies per cell Standard Deviation 19273.02
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 1, 4 hours, n=5, 7, 8, 6	76.0 Copies per cell Standard Deviation 209.69	41046.0 Copies per cell Standard Deviation 14859.06	43492.8 Copies per cell Standard Deviation 15811.41	43477.2 Copies per cell Standard Deviation 28963.40
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 1, 6 hours, n=5, 7, 8, 6	-130.8 Copies per cell Standard Deviation 273.14	68337.3 Copies per cell Standard Deviation 22986.71	77279.4 Copies per cell Standard Deviation 14115.24	55195.8 Copies per cell Standard Deviation 27523.26
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 1, 8 hours, n=5, 7, 7, 6	-60.4 Copies per cell Standard Deviation 242.85	68342.4 Copies per cell Standard Deviation 27742.23	70935.4 Copies per cell Standard Deviation 10888.79	50511.3 Copies per cell Standard Deviation 25067.72
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 1, 9 hours, n=1, 6, 0, 0	50.0 Copies per cell Standard Deviation NA NA indicates that standard deviation could not be calculated for a single participant.	46941.7 Copies per cell Standard Deviation 15418.31	—	—
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 1, 12 hours, n=4, 0, 7, 6	-9.8 Copies per cell Standard Deviation 267.43	—	56618.7 Copies per cell Standard Deviation 8092.43	40765.8 Copies per cell Standard Deviation 21505.21
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 1, 16 hours, n=4, 6, 8, 6	30.8 Copies per cell Standard Deviation 353.27	35124.7 Copies per cell Standard Deviation 31051.56	47713.4 Copies per cell Standard Deviation 7841.92	29753.0 Copies per cell Standard Deviation 15501.29
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 2, n=5, 7, 8, 6	-41.2 Copies per cell Standard Deviation 263.98	14020.9 Copies per cell Standard Deviation 2453.61	26096.8 Copies per cell Standard Deviation 5228.98	22559.8 Copies per cell Standard Deviation 13107.67
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 3, n=5, 7, 8, 6	-29.0 Copies per cell Standard Deviation 351.20	13502.1 Copies per cell Standard Deviation 6856.86	19841.5 Copies per cell Standard Deviation 4986.13	20615.5 Copies per cell Standard Deviation 11473.73
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 4, n=5, 7, 8, 6	-90.0 Copies per cell Standard Deviation 332.42	11065.7 Copies per cell Standard Deviation 5053.88	17923.5 Copies per cell Standard Deviation 2476.65	17694.8 Copies per cell Standard Deviation 8442.57
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 5, n=5, 7, 8, 6	49.0 Copies per cell Standard Deviation 412.48	7781.6 Copies per cell Standard Deviation 2908.32	7139.3 Copies per cell Standard Deviation 2922.96	9209.5 Copies per cell Standard Deviation 5670.67
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 6, n=5, 7, 8, 6	-59.4 Copies per cell Standard Deviation 291.67	4706.7 Copies per cell Standard Deviation 4049.36	4795.4 Copies per cell Standard Deviation 2544.14	6093.3 Copies per cell Standard Deviation 3673.79
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 6, 1 hour, n=5, 7, 8, 6	10.0 Copies per cell Standard Deviation 566.43	20140.3 Copies per cell Standard Deviation 6799.16	6011.8 Copies per cell Standard Deviation 3638.55	6167.5 Copies per cell Standard Deviation 3965.76
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 14, n=5, 6, 8, 4	-84.4 Copies per cell Standard Deviation 321.06	-783.3 Copies per cell Standard Deviation 1407.22	564.3 Copies per cell Standard Deviation 374.97	1082.3 Copies per cell Standard Deviation 1638.04
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 1, 30 minutes, n=5, 7, 8, 6	10.8 Copies per cell Standard Deviation 168.01	20952.1 Copies per cell Standard Deviation 9089.08	22141.3 Copies per cell Standard Deviation 9619.64	23518.7 Copies per cell Standard Deviation 12011.07
Change From Baseline in Bound CD3 Copies on CD8+ Cells Day 1, 1 hour, n=5, 7, 8, 6	85.8 Copies per cell Standard Deviation 253.77	28365.3 Copies per cell Standard Deviation 9711.56	34147.9 Copies per cell Standard Deviation 11206.05	32445.0 Copies per cell Standard Deviation 16424.62

SECONDARY outcome

Timeframe: Day-1, Month 3 and Month 6

Population: Safety population

Samples were analyzed for the presence of anti-Otelixizumab antibodies using a validated immunoelectrochemiluminescent (ECL) assay.

Outcome measures

Outcome measures
Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Number of Participants With Anti-drug Antibody Binding Month 3, Negative who were Positive previously	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibody Binding Month 6, Negative	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibody Binding Month 6, Positive	2 Participants	8 Participants	8 Participants	7 Participants
Number of Participants With Anti-drug Antibody Binding Day -1, Negative	3 Participants	9 Participants	8 Participants	6 Participants
Number of Participants With Anti-drug Antibody Binding Day-1, Positive	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Anti-drug Antibody Binding Month 3, Negative	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibody Binding Month 3, Positive	2 Participants	9 Participants	8 Participants	7 Participants
Number of Participants With Anti-drug Antibody Binding Month 3, Newly Positive	0 Participants	9 Participants	8 Participants	6 Participants
Number of Participants With Anti-drug Antibody Binding Month 6, Newly Positive	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibody Binding Month 6, Negative who were Positive previously	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Otelixizumab 9 mg

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Otelixizumab 18 mg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Otelixizumab 27 mg

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=5 participants at risk Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 participants at risk Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 participants at risk Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 participants at risk Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Injury, poisoning and procedural complications Fall	0.00% 0/5 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	11.1% 1/9 • Number of events 1 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/8 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/7 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.
Injury, poisoning and procedural complications Fibula fracture	20.0% 1/5 • Number of events 1 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/9 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/8 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/7 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/5 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/9 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	12.5% 1/8 • Number of events 2 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/7 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/5 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/9 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	12.5% 1/8 • Number of events 1 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/7 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/5 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	11.1% 1/9 • Number of events 1 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/8 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/7 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.
Infections and infestations Cytomegalovirus infection	0.00% 0/5 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/9 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	0.00% 0/8 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.	14.3% 1/7 • Number of events 1 • On treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 36 months. Safety population was used. Safety population comprised of all participants who received at least one dose of a study treatment.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Measure	Placebo n=5 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=9 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=8 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg n=7 Participants Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test Month 6, n=5, 8, 7, 6	-0.0003 (100mmoll)/(pmolkgmin) Standard Deviation 0.00130	-0.0000 (100mmoll)/(pmolkgmin) Standard Deviation 0.00030	-0.0002 (100mmoll)/(pmolkgmin) Standard Deviation 0.00197	-0.0002 (100mmoll)/(pmolkgmin) Standard Deviation 0.00066
Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test Month 24, n=4, 4, 6, 6	0.0037 (100mmoll)/(pmolkgmin) Standard Deviation 0.00591	-0.0006 (100mmoll)/(pmolkgmin) Standard Deviation 0.00344	-0.0013 (100mmoll)/(pmolkgmin) Standard Deviation 0.01299	0.0023 (100mmoll)/(pmolkgmin) Standard Deviation 0.00351

Measure	Placebo n=8 Participants Participants received 0.9% weight/volume Sodium Chloride solution for injection daily for 6 Days	Otelixizumab 9 mg n=8 Participants Participants received 1.5 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 18 mg n=6 Participants Participants received 3 mg of OTX (intravenous solution for infusion) daily for 6 Days	Otelixizumab 27 mg Participants received 4.5 mg of OTX (intravenous solution for infusion) daily for 6 Days
Free Serum Otelixizumab Concentrations by Treatment Day 1, 1 hour, n=8, 8, 6	0.513 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	2.963 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	12.542 Nanogram per milliliter (ng/mL) Standard Deviation 7.9086	—
Free Serum Otelixizumab Concentrations by Treatment Day 1, Pre-dose, n=8, 8, 6	0.000 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	0.000 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	0.000 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	—
Free Serum Otelixizumab Concentrations by Treatment Day 1, 30 minutes, n=8, 8, 6	0.000 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	0.444 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	7.387 Nanogram per milliliter (ng/mL) Standard Deviation 4.8946	—
Free Serum Otelixizumab Concentrations by Treatment Day 1, 2 hours, n=8, 8, 6	2.995 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	7.606 Nanogram per milliliter (ng/mL) Standard Deviation 6.1836	23.598 Nanogram per milliliter (ng/mL) Standard Deviation 14.4526	—
Free Serum Otelixizumab Concentrations by Treatment Day 1, 4 hours, n=7, 8, 6	6.600 Nanogram per milliliter (ng/mL) Standard Deviation 5.2773	15.929 Nanogram per milliliter (ng/mL) Standard Deviation 9.8903	41.457 Nanogram per milliliter (ng/mL) Standard Deviation 26.3827	—
Free Serum Otelixizumab Concentrations by Treatment Day 1, 6 hours, n=8, 8, 6	11.870 Nanogram per milliliter (ng/mL) Standard Deviation 5.0544	24.899 Nanogram per milliliter (ng/mL) Standard Deviation 14.5630	100.148 Nanogram per milliliter (ng/mL) Standard Deviation 79.4845	—
Free Serum Otelixizumab Concentrations by Treatment Day 1, 9 hours, n=7, 8, 6	18.494 Nanogram per milliliter (ng/mL) Standard Deviation 6.0716	102.865 Nanogram per milliliter (ng/mL) Standard Deviation 111.2186	402.173 Nanogram per milliliter (ng/mL) Standard Deviation 246.4271	—
Free Serum Otelixizumab Concentrations by Treatment Day 1, 16 hours, n=7, 8, 6	0.000 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	30.758 Nanogram per milliliter (ng/mL) Standard Deviation 23.3494	212.487 Nanogram per milliliter (ng/mL) Standard Deviation 144.0899	—
Free Serum Otelixizumab Concentrations by Treatment Day 3, Pre-Dose, n=8, 8, 6	0.000 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	36.051 Nanogram per milliliter (ng/mL) Standard Deviation 35.6464	420.228 Nanogram per milliliter (ng/mL) Standard Deviation 344.7569	—
Free Serum Otelixizumab Concentrations by Treatment Day 4, Pre-Dose, n=8, 8, 6	0.523 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	114.993 Nanogram per milliliter (ng/mL) Standard Deviation 152.7864	829.148 Nanogram per milliliter (ng/mL) Standard Deviation 473.9342	—
Free Serum Otelixizumab Concentrations by Treatment Day 5, Pre-Dose, n=8, 8, 6	9.550 Nanogram per milliliter (ng/mL) Standard Deviation 16.2697	213.305 Nanogram per milliliter (ng/mL) Standard Deviation 257.3174	1088.808 Nanogram per milliliter (ng/mL) Standard Deviation 542.8032	—
Free Serum Otelixizumab Concentrations by Treatment Day 6, Pre-Dose, n=8, 8, 6	4.416 Nanogram per milliliter (ng/mL) Standard Deviation 3.2896	174.448 Nanogram per milliliter (ng/mL) Standard Deviation 258.4873	1386.008 Nanogram per milliliter (ng/mL) Standard Deviation 623.1118	—
Free Serum Otelixizumab Concentrations by Treatment Day 14, n=7, 8, 5	0.523 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	0.899 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	12.474 Nanogram per milliliter (ng/mL) Standard Deviation 8.7977	—
Free Serum Otelixizumab Concentrations by Treatment Day 1, 8 hours, n=8, 7, 6	70.088 Nanogram per milliliter (ng/mL) Standard Deviation 153.2593	37.657 Nanogram per milliliter (ng/mL) Standard Deviation 19.8741	146.298 Nanogram per milliliter (ng/mL) Standard Deviation 95.4089	—
Free Serum Otelixizumab Concentrations by Treatment Day 2, Pre-Dose, n=8, 8, 6	0.000 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	7.329 Nanogram per milliliter (ng/mL) Standard Deviation NA NA indicates that data could not be calculated as it was below the limit of quantification.	112.020 Nanogram per milliliter (ng/mL) Standard Deviation 124.1743	—
Free Serum Otelixizumab Concentrations by Treatment Day 6, 1 hour, n=8, 8, 6	413.488 Nanogram per milliliter (ng/mL) Standard Deviation 262.5248	2048.336 Nanogram per milliliter (ng/mL) Standard Deviation 1889.7194	2868.735 Nanogram per milliliter (ng/mL) Standard Deviation 771.5457	—