Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM

• Sponsor: Alexion Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00648739
• Collaborator: (none)
• Enrollment: 26
• Locations: 4
• Arm: 1
• Actual Duration (Months): 29.8
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study was to determine the safety and maximum tolerated dose (MTD) of ALXN6000 (samalizumab) in treating relapsing or refractory B-cell chronic lymphocytic leukemia (B-CLL) or multiple myeloma (MM) and to study how samalizumab may help the immune system fight tumors that express CD200.

Condition or Disease	Intervention/Treatment	Phase
B-cell Chronic Lymphocytic Leukemia; Multiple Myeloma	Drug: Samalizumab	Phase 1/Phase 2

Detailed Description

This was an open-label multicenter study for participants with relapsing or refractory B-CLL or MM. The study was planned to be conducted in 2 parts: Part A and Part B. Both parts were to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy (to the extent possible) of samalizumab in the target participant population. Part A was designed as the open-label, intravenous (IV) single dose-escalation portion of the study to determine the MTD and to assess the overall safety of different dose levels of up to 4 IV doses of samalizumab in participants with either refractory or relapsing B-CLL or MM. Initially, at least 3 participants would be enrolled into a cohort until a dose-limiting toxicity (DLT) was reached. If any 1 of the initial 3 participants in the cohort experienced a DLT, the cohort would be expanded to at least 6 participants.

After determination of the MTD in Part A, the Sponsor was to review the safety, PK, and relevant PD data to determine the dosing administration schedule for Part B. However, no participants were enrolled for Part B, as the study was terminated by the Sponsor for administrative reasons.

Participant enrollment in Cohort 7 (600 milligrams per square meter [mg/m^2] dose level), Part A, was halted after enrollment of the first participant. The study was terminated by the Sponsor for administrative reasons and not due to any safety concerns. Participants who were on study at the time of study termination were allowed to continue until the expiry date of the drug lot being used and then were followed for 30 (±1) days per protocol. The study was terminated by the Sponsor at that time. Part B of the study was not conducted.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I/II Open Label Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of ALXN6000 In Patients With Relapsing Or Refractory B-Cell Chronic Lymphocytic Leukemia Or Multiple Myeloma
• Actual Study Start Date: Jun 19, 2008
• Actual Primary Completion Date: Dec 14, 2010
• Actual Study Completion Date: Dec 14, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Samalizumab All doses of samalizumab were individualized based on the participant's body surface area in mg/m^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. If no participants enrolled into a cohort experienced a DLT, escalation to the next dose level occurred with a new cohort. If any 1 of the initial 3 participants in the cohort experienced a DLT, the cohort was expanded to at least 6 participants. Then, if less than one third of participants within the cohort experienced a DLT, escalation to the next dose level occurred with a new cohort. Dose cohorts were enrolled sequentially.

Drug: Samalizumab; Samalizumab is a humanized anti-CD200 monoclonal antibody.; Other Names: ALXN6000

Outcome Measures

Primary Outcome Measures

1. Maximum Tolerated Dose (MTD) Of Samalizumab [From first dose through 10 weeks after the last dose]

   The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions.

2. Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) [From first dose through 10 weeks after the last dose]

   A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Outcome Measures

1. Percent Of Bound Samalizumab On B-Cell Chronic Lymphocytic Leukemia (B-CLL) Cells In Participants With B-CLL At Baseline (Predose) And Day 1 (Postdose) [Baseline (Predose) and Day 1 (Postdose)]

   Bound samalizumab was detected using a monoclonal antibody (mAb) specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as the percent of B-CLL cells bound by samalizumab. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.

2. Density Of B-CLL Cells Bound At Baseline (Predose) And Day 1 (Postdose) [Baseline (Predose) and Day 1 (Postdose)]

   Bound samalizumab was detected using a mAb specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as mean channel fluorescence intensity (MFI) of bound samalizumab to provide an indication of the density of bound samalizumab on target B-CLL cells. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.

3. Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate [From first dose through 10 weeks after the last dose]

   Clinical responses assessed using the Modified NCI Working Group Response Criteria. Overall Response Rate (ORR)=percentage of participants who maintained best response for ≥1 month after achieving that best response and having complete response (CR), partial response (PR), nodular partial response (nPR), or stable disease (SD). CR=absence of lymphadenopathy, hepatomegaly, or splenomegaly and normal complete blood count (CBC). PR=≥50% decrease in peripheral lymphocyte count or ≥50% reduction in lymphadenopathy, hepatomegaly, or splenomegaly and normal or 50% improvement over baseline CBC. nPR=CR participants with lymphoid aggregates. Progressive disease (PD)=>50% increase for >2 lymph nodes, spleen and/or liver size, or absolute number of circulating lymphocytes; or new lymph nodes. SD=have not achieved CR, PR, or nPR or have not shown PD. Features must be exhibited for ≥1month for CR/PR. Number of participants with individual best response and ORR for each cohort is presented.

4. Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab [From first dose through 10 weeks after the last dose]

   Clinical responses of samalizumab were assessed using the International Myeloma Working Group Uniform Response Criteria. ORR was defined as the percentage of participants who had either stringent complete response, complete response, very good partial response, or partial response on 2 consecutive assessments made at any time before the administration of any new therapy. The number of participants with the individual best response and ORR for each cohort is presented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Relapsing or Refractory B-CLL or MM

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

• Anticipated survival of greater than 6 months

• Female participants of childbearing potential must agree to use 2 forms of contraception

• Participants must have a standard indication for treatment of their malignancy

• Is willing and able to give written informed consent prior to any procedure not considered standard of care

Exclusion Criteria:

• Absolute neutrophil count (ANC) < 1000 x 10^9/liter (L)

• Platelet count < 50,000 x 10^9/L

• Pregnant or lactating women

• Prior history of autoimmune hemolysis requiring therapy

• Prior history of immune thrombocytopenia

• Active autoimmune disease requiring immunosuppressive therapy

• Positive Coombs' Test (neither direct or indirect)

• Ongoing corticosteroid treatment equivalent to the mineralocorticoid potency of 10 milligrams (mg) /day of prednisone, or greater, for any condition

• Prior stem cell transplantation within 4 weeks prior to enrollment

• Prior chemotherapy for the applicable malignancy within 30 days of enrollment

• Neurosurgery or cranial radiation therapy within 1 year of enrollment

• Clinically significant renal, hepatic, or cardiopulmonary disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Tucson	Arizona	United States	85719
2		Atlanta	Georgia	United States	30322
3		Morristown	New Jersey	United States	07962
4		Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Alexion Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexion Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00648739
• Other Study ID Numbers: C07-003
• First Posted: Apr 1, 2008
• Last Update Posted: Mar 5, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Alexion Pharmaceuticals: B-cell Chronic Lymphocytic Leukemia; Leukemia; Multiple Myeloma; CD200; Anti-CD200
• Additional relevant MeSH terms: Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

Participant Flow

Arm/Group Title	Samalizumab 50 mg/m^2	Samalizumab 100 mg/m^2	Samalizumab 200 mg/m^2	Samalizumab 300 mg/m^2	Samalizumab 400 mg/m^2	Samalizumab 500 mg/m^2	Samalizumab 600 mg/m^2
Arm/Group Description	Participants assigned to this dose cohort received a single intravenous (IV) dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Period Title: Overall Study
STARTED	4	5	3	3	3	7	1
Received at Least 1 Dose of Study Drug	4	5	3	3	3	7	1
COMPLETED	2	3	0	1	1	2	0
NOT COMPLETED	2	2	3	2	2	5	1

Baseline Characteristics

Arm/Group Title	Samalizumab
Arm/Group Description	All doses of samalizumab were individualized based on the participant's body surface area in mg/m^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Overall Participants	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.8629 (12.14)
Sex: Female, Male (Count of Participants)
Female	8 30.8%
Male	18 69.2%
Type of Malignancy (Count of Participants)
B-Cell Chronic Lymphocytic Leukemia	23 88.5%
Multiple Myeloma	3 11.5%

Outcome Measures

1. Primary Outcome

Title	Maximum Tolerated Dose (MTD) Of Samalizumab
Description	The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions.
Time Frame	From first dose through 10 weeks after the last dose

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of samalizumab.

Arm/Group Title	Samalizumab
Arm/Group Description	All doses of samalizumab were individualized based on the participant's body surface area in mg/m^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Measure Participants	26
Number [mg/m^2]	NA

2. Primary Outcome

Title	Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame	From first dose through 10 weeks after the last dose

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of samalizumab.

Arm/Group Title	Samalizumab 50 mg/m^2	Samalizumab 100 mg/m^2	Samalizumab 200 mg/m^2	Samalizumab 300 mg/m^2	Samalizumab 400 mg/m^2	Samalizumab 500 mg/m^2	Samalizumab 600 mg/m^2	Overall
Arm/Group Description	Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	All doses of samalizumab were individualized based on the participant's body surface area in mg/m^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Measure Participants	4	5	3	3	3	7	1	26
At Least 1 TEAE	4 15.4%	5 NaN	3 NaN	3 NaN	3 NaN	6 NaN	1 NaN	25 NaN
Treatment-emergent Serious Adverse Event	1 3.8%	2 NaN	0 NaN	1 NaN	1 NaN	1 NaN	0 NaN	6 NaN
Discontinued due to Adverse Events	1 3.8%	0 NaN	1 NaN	2 NaN	1 NaN	0 NaN	0 NaN	5 NaN
Adverse Events Leading to Death	0 0%	1 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	1 NaN

3. Secondary Outcome

Title	Percent Of Bound Samalizumab On B-Cell Chronic Lymphocytic Leukemia (B-CLL) Cells In Participants With B-CLL At Baseline (Predose) And Day 1 (Postdose)
Description	Bound samalizumab was detected using a monoclonal antibody (mAb) specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as the percent of B-CLL cells bound by samalizumab. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.
Time Frame	Baseline (Predose) and Day 1 (Postdose)

Outcome Measure Data

Analysis Population Description

All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m^2 dose level.

Arm/Group Title	Samalizumab 50 mg/m^2	Samalizumab 100 mg/m^2	Samalizumab 200 mg/m^2	Samalizumab 300 mg/m^2	Samalizumab 400 mg/m^2	Samalizumab 500 mg/m^2
Arm/Group Description	Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Measure Participants	4	5	2	2	3	5
Baseline (Predose)	0.60	0.80	0.50	0.60	3.20	1.40
Day 1 (Postdose)	2.50	3.90	28.70	16.80	13.50	3.40

4. Secondary Outcome

Title	Density Of B-CLL Cells Bound At Baseline (Predose) And Day 1 (Postdose)
Description	Bound samalizumab was detected using a mAb specific for samalizumab. The binding of samalizumab to CD200 on peripheral B-CLL tumor cells was evaluated in participants with B-CLL by flow cytometry and expressed as mean channel fluorescence intensity (MFI) of bound samalizumab to provide an indication of the density of bound samalizumab on target B-CLL cells. For participants with insufficient numbers of peripheral B-CLL for analysis, the samples were documented as "unevaluable" and an analysis was not performed.
Time Frame	Baseline (Predose) and Day 1 (Postdose)

Outcome Measure Data

Analysis Population Description

All participants with B-CLL who had evaluable assessments for bound samalizumab were included in the analysis. No participants with B-CLL received samalizumab at the 600 mg/m^2 dose level.

Arm/Group Title	Samalizumab 50 mg/m^2	Samalizumab 100 mg/m^2	Samalizumab 200 mg/m^2	Samalizumab 300 mg/m^2	Samalizumab 400 mg/m^2	Samalizumab 500 mg/m^2
Arm/Group Description	Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Measure Participants	4	5	2	2	3	5
Baseline (Predose)	2.95	4.10	3.25	2.35	2.40	1.40
Day 1 (Postdose)	3.85	7.10	17.95	11.20	5.80	2.30

5. Secondary Outcome

Title	Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate
Description	Clinical responses assessed using the Modified NCI Working Group Response Criteria. Overall Response Rate (ORR)=percentage of participants who maintained best response for ≥1 month after achieving that best response and having complete response (CR), partial response (PR), nodular partial response (nPR), or stable disease (SD). CR=absence of lymphadenopathy, hepatomegaly, or splenomegaly and normal complete blood count (CBC). PR=≥50% decrease in peripheral lymphocyte count or ≥50% reduction in lymphadenopathy, hepatomegaly, or splenomegaly and normal or 50% improvement over baseline CBC. nPR=CR participants with lymphoid aggregates. Progressive disease (PD)=>50% increase for >2 lymph nodes, spleen and/or liver size, or absolute number of circulating lymphocytes; or new lymph nodes. SD=have not achieved CR, PR, or nPR or have not shown PD. Features must be exhibited for ≥1month for CR/PR. Number of participants with individual best response and ORR for each cohort is presented.
Time Frame	From first dose through 10 weeks after the last dose

Outcome Measure Data

Analysis Population Description

All participants with B-CLL who received at least 1 dose of samalizumab.

Arm/Group Title	Samalizumab 50 mg/m^2	Samalizumab 100 mg/m^2	Samalizumab 200 mg/m^2	Samalizumab 300 mg/m^2	Samalizumab 400 mg/m^2	Samalizumab 500 mg/m^2
Arm/Group Description	Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV 300 mg/m^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Measure Participants	4	5	3	3	3	5
Progressive Disease	1 3.8%	1 NaN	0 NaN	0 NaN	1 NaN	2 NaN
Partial Response	0 0%	0 NaN	0 NaN	0 NaN	1 NaN	0 NaN
Stable Disease	3 11.5%	4 NaN	2 NaN	3 NaN	1 NaN	3 NaN
Not Evaluable	0 0%	0 NaN	1 NaN	0 NaN	0 NaN	0 NaN
ORR	0 0%	0 NaN	0 NaN	0 NaN	1 NaN	0 NaN

6. Secondary Outcome

Title	Clinical Response Of Participants With Multiple Myeloma (MM) Following Dosing With Samalizumab
Description	Clinical responses of samalizumab were assessed using the International Myeloma Working Group Uniform Response Criteria. ORR was defined as the percentage of participants who had either stringent complete response, complete response, very good partial response, or partial response on 2 consecutive assessments made at any time before the administration of any new therapy. The number of participants with the individual best response and ORR for each cohort is presented.
Time Frame	From first dose through 10 weeks after the last dose

Outcome Measure Data

Analysis Population Description

All participants with MM who received at least 1 dose of samalizumab.

Arm/Group Title	Samalizumab 500 mg/m^2	Samalizumab 600 mg/m^2
Arm/Group Description	Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.	Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Measure Participants	2	1
Progressive Disease	2 7.7%	1 NaN
Partial Response	0 0%	0 NaN
Stable Disease	0 0%	0 NaN
Not Evaluable	0 0%	0 NaN
ORR	0 0%	0 NaN

Adverse Events

Time Frame	From Day 1 (Postdose) to the end of the follow-up period (10 weeks after the last dose)
Arm/Group Title	Samalizumab 50 mg/m^2		Samalizumab 100 mg/m^2		Samalizumab 200 mg/m^2		Samalizumab 300 mg/m^2		Samalizumab 400 mg/m^2		Samalizumab 500 mg/m^2		Samalizumab 600 mg/m^2
Arm/Group Description	Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.		Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.		Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.		Participants assigned to this dose cohort received a single IV 300 mg/m^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.		Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.		Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.		Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
All Cause Mortality
	Samalizumab 50 mg/m^2		Samalizumab 100 mg/m^2		Samalizumab 200 mg/m^2		Samalizumab 300 mg/m^2		Samalizumab 400 mg/m^2		Samalizumab 500 mg/m^2		Samalizumab 600 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Serious Adverse Events
	Samalizumab 50 mg/m^2		Samalizumab 100 mg/m^2		Samalizumab 200 mg/m^2		Samalizumab 300 mg/m^2		Samalizumab 400 mg/m^2		Samalizumab 500 mg/m^2		Samalizumab 600 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/4 (25%)		2/5 (40%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		1/7 (14.3%)		0/1 (0%)
Eye disorders
Visual acuity reduced	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Gastrointestinal disorders
Ascites	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
General disorders
Pyrexia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Infections and infestations
Pneumonia	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Respiratory syncytial virus infection	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
Muscular weakness	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Nervous system disorders
Hemorrhage intracranial	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Renal and urinary disorders
Renal failure	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Pleural effusion	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Surgical and medical procedures
Cholecystectomy	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Samalizumab 50 mg/m^2		Samalizumab 100 mg/m^2		Samalizumab 200 mg/m^2		Samalizumab 300 mg/m^2		Samalizumab 400 mg/m^2		Samalizumab 500 mg/m^2		Samalizumab 600 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		5/5 (100%)		3/3 (100%)		3/3 (100%)		3/3 (100%)		6/7 (85.7%)		1/1 (100%)
Blood and lymphatic system disorders
Anaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Lymphadenopathy	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Neutropenia	2/4 (50%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Thrombocytopenia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Cardiac disorders
Pericardial effusion	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Tachycardia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Eye disorders
Conjunctival haemorrhage	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Eye irritation	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Eye pain	2/4 (50%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Night blindness	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Photophobia	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Photopsia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Retinal haemorrhage	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Vision blurred	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/7 (28.6%)		0/1 (0%)
Vitreous floaters	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Gastrointestinal disorders
Abdominal distension	0/4 (0%)		1/5 (20%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Abdominal pain	1/4 (25%)		1/5 (20%)		0/3 (0%)		2/3 (66.7%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Colitis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Constipation	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		1/1 (100%)
Diarrhoea	1/4 (25%)		1/5 (20%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Dry mouth	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Dysphagia	1/4 (25%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Gastrooesophageal reflux disease	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Impaired gastric emptying	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Inguinal hernia	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Nausea	1/4 (25%)		2/5 (40%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Vomiting	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
General disorders
Asthenia	0/4 (0%)		2/5 (40%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Chest pain	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Chills	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Face oedema	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Fatigue	2/4 (50%)		2/5 (40%)		1/3 (33.3%)		3/3 (100%)		1/3 (33.3%)		2/7 (28.6%)		1/1 (100%)
Infusion site extravasation	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Injection site extravasation	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Oedema peripheral	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		1/1 (100%)
Pain	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Peripheral coldness	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Pyrexia	1/4 (25%)		2/5 (40%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/7 (14.3%)		0/1 (0%)
Hepatobiliary disorders
Cholecystitis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Cholelithiasis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Hepatic function abnormal	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Immune system disorders
Hypersensitivity	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Hypogammaglobulinaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Infections and infestations
Bronchitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Candidiasis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Cellulitis	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Folliculitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Infected epidermal cyst	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Influenza	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Localised infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Pharyngitis	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Pneumococcal bacteraemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Pneumonia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/7 (28.6%)		0/1 (0%)
Respiratory tract infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Sepsis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Sinusitis	0/4 (0%)		1/5 (20%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Tooth abscess	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Upper respiratory tract infection	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		2/3 (66.7%)		1/7 (14.3%)		0/1 (0%)
Urinary tract infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Viral infection	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Injury, poisoning and procedural complications
Contusion	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		2/7 (28.6%)		0/1 (0%)
Excoriation	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Medication error	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Procedural pain	0/4 (0%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Skin laceration	0/4 (0%)		1/5 (20%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Investigations
Blood creatinine increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Blood viscosity increased	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Haemoglobin	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Platelet count	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Platelet count decreased	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Metabolism and nutrition disorders
Anorexia	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/7 (14.3%)		1/1 (100%)
Dehydration	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Hypercalcaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Hypercholesterolaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Hyperkalaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Hyperuricaemia	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Hypokalaemia	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/7 (14.3%)		1/1 (100%)
Back pain	1/4 (25%)		0/5 (0%)		1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Muscle spasms	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Musculoskeletal chest pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Musculoskeletal pain	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Musculoskeletal stiffness	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Myalgia	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Pain in extremity	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		1/7 (14.3%)		0/1 (0%)
Nervous system disorders
Dizziness	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Headache	1/4 (25%)		1/5 (20%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		2/7 (28.6%)		0/1 (0%)
Paraesthesia	1/4 (25%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Somnolence	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		1/1 (100%)
Psychiatric disorders
Anxiety	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Insomnia	0/4 (0%)		0/5 (0%)		0/3 (0%)		2/3 (66.7%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Renal and urinary disorders
Micturition urgency	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Pollakiuria	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Urinary hesitation	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Urinary incontinence	1/4 (25%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Atelectasis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Cough	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Dyspnoea	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		2/7 (28.6%)		0/1 (0%)
Epistaxis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Pneumonitis	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Pulmonary oedema	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Respiratory failure	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Skin and subcutaneous tissue disorders
Acne	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Alopecia	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Blood blister	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Ecchymosis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Erythema	0/4 (0%)		0/5 (0%)		0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Night sweats	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		1/7 (14.3%)		0/1 (0%)
Pruritus	1/4 (25%)		2/5 (40%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Rash	1/4 (25%)		2/5 (40%)		1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Urticaria	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Surgical and medical procedures
Dermabrasion	1/4 (25%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)
Vascular disorders
Haematoma	0/4 (0%)		0/5 (0%)		0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/7 (0%)		0/1 (0%)
Phlebitis	0/4 (0%)		1/5 (20%)		0/3 (0%)		0/3 (0%)		0/3 (0%)		0/7 (0%)		0/1 (0%)

Limitations/Caveats

The study was terminated by the Sponsor for administrative reasons and not due to any safety concerns. Part B of the study was not conducted.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.