(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02047604
• Collaborator: (none)
• Enrollment: 41
• Locations: 12
• Arms: 6
• Actual Duration (Months): 39.7
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: SAN-300 0.5 mg/kg QW; Drug: SAN-300 1.0 mg/kg QW; Drug: SAN-300 2.0 mg/kg QOW; Drug: SAN-300 4.0 mg/kg QOW; Drug: SAN-300 4.0 mg/kg QW; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
• Actual Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Feb 23, 2017
• Actual Study Completion Date: Mar 23, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A - SAN-300 0.5 mg/kg QW SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks	Drug: SAN-300 0.5 mg/kg QW
Experimental: Cohort B - SAN-300 1.0 mg/kg QW SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks	Drug: SAN-300 1.0 mg/kg QW
Experimental: Cohort C - SAN-300 2.0 mg/kg QOW SAN-300 2.0 mg/kg subcutaneous every other week for six weeks	Drug: SAN-300 2.0 mg/kg QOW
Experimental: Cohort D - SAN-300 4.0 mg/kg QOW SAN-300 4.0 mg/kg subcutaneous every other week for six weeks	Drug: SAN-300 4.0 mg/kg QOW
Experimental: Cohort E - SAN-300 4.0 mg/kg QW SAN-300 4.0 mg/kg subcutaneous every other week for six weeks	Drug: SAN-300 4.0 mg/kg QW
Placebo Comparator: Placebo Placebo dosing	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [10 weeks]

   Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.

Secondary Outcome Measures

1. Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP) [Baseline, End of Treatment Visit (Week 7)]

   DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome.

2. Number of Participants With American College of Rheumatology 20 (ACR20) Response. [End of Treatment Visit (Week 7)]

   A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following: Swollen joint count (66 joints) Tender joint count (68 joints) and At least three of the following five assessments: Patient's assessment of pain Patient's global assessment of disease activity Physician's global assessment of disease activity Patient's assessment of physical function, as measured by the HAQ-DI CRP

Other Outcome Measures

1. Change From Baseline in the Health Assessment Questionnaire-Disease Index (HAQ-DI) [Baseline, End of Treatment Visit (Week 7)]

   HAQ assesses the degree of difficulty a participant has had in accomplishing tasks in eight functional areas, over the previous week. dressing and grooming, rising, eating, walking, hygiene, reach, grip, common daily activities. For each of these categories, participants report amount of difficulty they have in performing two or three specific activities. There are four possible responses for the HAQ questions: without ANY difficulty (0), with SOME difficulty (1), with MUCH difficulty (2) and UNABLE to do (3). Scores for each of the eight categories are calculated. HAQ is calculated by adjusting the score for each of these categories, if necessary, based upon the patient's use of an aid, device, or assistance for that category, totaling the sum of the category scores and dividing by the number of categories answered. HAQ can range from 0 to 3. Higher scores (greater level of difficulty) indicate worse outcome.

2. Bone Erosion Detected Using Magnetic Resonance Imaging (MRI) Findings of the Hand and Wrist - Change From Baseline [Baseline, End of Treatment Visit (Week 7)]

   Bone Erosion detected by MRI of hand/wrist was scored using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA MRI scoring (RAMRIS) system. Bone erosion was scored 0-10, according to the proportion (in increments of 10%) of erosion of articular bone: 0: 0%, 1: 1%-10%, 2: 11%-20%, ……..10: 91%-100%. Higher scores (more erosion) indicate worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010

2. 18 to 75 years of age, inclusive, at the time of informed consent

3. Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization

4. Inadequate response to therapy or discontinuation of therapy because of unacceptable toxicity from at least one prior traditional or biologic disease-modifying anti-rheumatic drug (DMARD)

5. Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization

Exclusion Criteria:

1. Functional Class IV as defined by ACR classification of functional status in RA

2. History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)

3. History of malignancy or carcinoma in situ within the 5 years before Screening or any history of melanoma. Patients with history of excised or adequately treated non-melanoma skin cancer are eligible

4. Evidence of clinically significant uncontrolled concurrent diseases such as cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases

5. History of recurrent clinically significant infections

6. Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization

7. History of severe allergic or anaphylactic reactions to other biologic agents

8. History of allergies to murine protein

9. Surgery within 3 months before randomization (other than minor cosmetic surgery or minor dental procedures) or plans for a surgical procedure during the Treatment Period or Follow-up Period

10. History of tuberculosis or latent infection currently undergoing treatment

11. History of malaria

12. Treatment regimen with prednisone that is either over 10 mg/day (or equivalent dose of another corticosteroid) or is not taken at a stable dose of ≤ 10 mg/day for at least 4 weeks before randomization

13. Intra-articular corticosteroid injection(s) within 4 weeks before randomization

14. Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study

15. Abnormal laboratory value at Screening or Day -1 considered clinically significant

16. Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)

17. Positive for human immunodeficiency virus (HIV) antibody

18. History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santarus Clinical Investigational Site 1012	Phoenix	Arizona	United States	85023
2	Santarus Clinical Investigational Site 1004	El Cajon	California	United States	92020
3	Santarus Clinical Investigational Site 1008	Los Angeles	California	United States	90048
4	Santarus Clinical Investigational Site 1011	San Leandro	California	United States	94578
5	Santarus Clinical Investigational Site 1013	Brandon	Florida	United States	33511
6	Santarus Clinical Investigational Site 1003	Palm Harbor	Florida	United States	34684
7	Santarus Clinical Investigational Site 1017	Florissant	Missouri	United States	63031
8	Santarus Clinical Investigational Site 1009	Brooklyn	New York	United States	11201
9	Santarus Clinical Investigational Site 1019	Chapel Hill	North Carolina	United States	27599
10	Santarus Clinical Investigational Site 1014	Charlotte	North Carolina	United States	28210
11	Santarus Clinical Investigational Site 1006	Salisbury	North Carolina	United States	28144
12	Santarus Clinical Investigational Site 1001	Middleburg Heights	Ohio	United States	44130

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 28, 2016
• Statistical Analysis Plan - Mar 20, 2017

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT02047604
• Other Study ID Numbers: C2013-0302; 2013-003719-23
• First Posted: Jan 28, 2014
• Last Update Posted: Jun 21, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by Bausch Health Americas, Inc.: Phase 2a multiple ascending dose, Anti-Very Late Antigen-1
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

Participant Flow

Arm/Group Title	Cohort A - SAN-300 0.5 mg/kg QW	Cohort B - SAN-300 1.0 mg/kg QW	Cohort C - SAN-300 2.0 mg/kg QOW	Cohort D - SAN-300 4.0 mg/kg QOW	Cohort E - SAN-300 4.0 mg/kg QW	Placebo
Arm/Group Description	SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks	SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks	SAN-300 2.0 mg/kg subcutaneous every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous every week for six weeks	Placebo dosing
Period Title: Overall Study
STARTED	6	7	6	6	6	10
COMPLETED	6	7	6	6	5	9
NOT COMPLETED	0	0	0	0	1	1

Baseline Characteristics

Arm/Group Title	Cohort A - SAN-300 0.5 mg/kg QW	Cohort B - SAN-300 1.0 mg/kg QW	Cohort C - SAN-300 2.0 mg/kg QOW	Cohort D - SAN-300 4.0 mg/kg QOW	Cohort E - SAN-300 4.0 mg/kg QW	Placebo	Total
Arm/Group Description	SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks	SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks	SAN-300 2.0 mg/kg subcutaneous every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous once weekly for six weeks	Placebo dosing	Total of all reporting groups
Overall Participants	6	7	6	6	6	10	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.2 (2.82)	60.9 (1.65)	59.2 (4.87)	49.0 (6.59)	55.5 (4.42)	57.5 (2.85)	56.6 (1.59)
Sex: Female, Male (Count of Participants)
Female	5 83.3%	4 57.1%	6 100%	4 66.7%	5 83.3%	9 90%	33 80.5%
Male	1 16.7%	3 42.9%	0 0%	2 33.3%	1 16.7%	1 10%	8 19.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 16.7%	1 14.3%	1 16.7%	0 0%	2 33.3%	1 10%	6 14.6%
Not Hispanic or Latino	5 83.3%	6 85.7%	5 83.3%	6 100%	4 66.7%	9 90%	35 85.4%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	1 2.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	1 16.7%	0 0%	2 33.3%	0 0%	2 33.3%	1 10%	6 14.6%
White	4 66.7%	7 100%	4 66.7%	5 83.3%	4 66.7%	8 80%	32 78%
More than one race	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.4%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	1 2.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A - SAN-300 0.5 mg/kg QW	Cohort B - SAN-300 1.0 mg/kg QW	Cohort C - SAN-300 2.0 mg/kg QOW	Cohort D - SAN-300 4.0 mg/kg QOW	Cohort E - SAN-300 4.0 mg/kg QW	Placebo
Arm/Group Description	SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks	SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks	SAN-300 2.0 mg/kg subcutaneous every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous every week for six weeks	Placebo dosing
Measure Participants	6	7	6	6	6	10
Count of Participants [Participants]	5 83.3%	4 57.1%	2 33.3%	6 100%	4 66.7%	7 70%

2. Secondary Outcome

Title	Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)
Description	DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome.
Time Frame	Baseline, End of Treatment Visit (Week 7)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A - SAN-300 0.5 mg/kg QW	Cohort B - SAN-300 1.0 mg/kg QW	Cohort C - SAN-300 2.0 mg/kg QOW	Cohort D - SAN-300 4.0 mg/kg QOW	Cohort E - SAN-300 4.0 mg/kg QW	Placebo
Arm/Group Description	SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks	SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks	SAN-300 2.0 mg/kg subcutaneous every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous every week for six weeks	Placebo dosing
Measure Participants	6	7	6	6	6	10
Mean (Standard Error) [units on a scale]	-4.433 (1.2736)	-3.663 (0.9716)	-2.002 (0.8276)	-3.818 (1.9164)	-2.928 (1.9874)	-3.028 (1.2505)

3. Secondary Outcome

Title	Number of Participants With American College of Rheumatology 20 (ACR20) Response.
Description	A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following: Swollen joint count (66 joints) Tender joint count (68 joints) and At least three of the following five assessments: Patient's assessment of pain Patient's global assessment of disease activity Physician's global assessment of disease activity Patient's assessment of physical function, as measured by the HAQ-DI CRP
Time Frame	End of Treatment Visit (Week 7)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A - SAN-300 0.5 mg/kg QW	Cohort B - SAN-300 1.0 mg/kg QW	Cohort C - SAN-300 2.0 mg/kg QOW	Cohort D - SAN-300 4.0 mg/kg QOW	Cohort E - SAN-300 4.0 mg/kg QW	Placebo
Arm/Group Description	SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks	SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks	SAN-300 2.0 mg/kg subcutaneous every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous every week for six weeks	Placebo dosing
Measure Participants	6	7	6	6	6	10
Count of Participants [Participants]	3 50%	3 42.9%	1 16.7%	2 33.3%	1 16.7%	3 30%

4. Other Pre-specified Outcome

Title	Change From Baseline in the Health Assessment Questionnaire-Disease Index (HAQ-DI)
Description	HAQ assesses the degree of difficulty a participant has had in accomplishing tasks in eight functional areas, over the previous week. dressing and grooming, rising, eating, walking, hygiene, reach, grip, common daily activities. For each of these categories, participants report amount of difficulty they have in performing two or three specific activities. There are four possible responses for the HAQ questions: without ANY difficulty (0), with SOME difficulty (1), with MUCH difficulty (2) and UNABLE to do (3). Scores for each of the eight categories are calculated. HAQ is calculated by adjusting the score for each of these categories, if necessary, based upon the patient's use of an aid, device, or assistance for that category, totaling the sum of the category scores and dividing by the number of categories answered. HAQ can range from 0 to 3. Higher scores (greater level of difficulty) indicate worse outcome.
Time Frame	Baseline, End of Treatment Visit (Week 7)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A - SAN-300 0.5 mg/kg QW	Cohort B - SAN-300 1.0 mg/kg QW	Cohort C - SAN-300 2.0 mg/kg QOW	Cohort D - SAN-300 4.0 mg/kg QOW	Cohort E - SAN-300 4.0 mg/kg QW	Placebo
Arm/Group Description	SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks	SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks	SAN-300 2.0 mg/kg subcutaneous every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous every week for six weeks	Placebo dosing
Measure Participants	6	7	6	6	6	10
Mean (Standard Error) [units on a scale]	-0.333 (0.335)	-0.018 (0.064)	-0.146 (0.060)	-0.313 (0.313)	0.042 (0.070)	-0.111 (0.129)

5. Other Pre-specified Outcome

Title	Bone Erosion Detected Using Magnetic Resonance Imaging (MRI) Findings of the Hand and Wrist - Change From Baseline
Description	Bone Erosion detected by MRI of hand/wrist was scored using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA MRI scoring (RAMRIS) system. Bone erosion was scored 0-10, according to the proportion (in increments of 10%) of erosion of articular bone: 0: 0%, 1: 1%-10%, 2: 11%-20%, ……..10: 91%-100%. Higher scores (more erosion) indicate worse outcome.
Time Frame	Baseline, End of Treatment Visit (Week 7)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort A - SAN-300 0.5 mg/kg QW	Cohort B - SAN-300 1.0 mg/kg QW	Cohort C - SAN-300 2.0 mg/kg QOW	Cohort D - SAN-300 4.0 mg/kg QOW	Cohort E - SAN-300 4.0 mg/kg QW	Placebo
Arm/Group Description	SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks	SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks	SAN-300 2.0 mg/kg subcutaneous every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks	SAN-300 4.0 mg/kg subcutaneous every week for six weeks	Placebo dosing
Measure Participants	5	6	5	4	3	8
Mean (Standard Error) [units on a scale]	-0.73 (0.496)	0.25 (0.214)	0 (0)	0.13 (0.125)	0.22 (0.222)	0.13 (0.125)

Adverse Events

Time Frame	Adverse events data are collected during a 10-week period, which included 6 weeks of treatment and 4 weeks of follow up.
Arm/Group Title	Cohort A - SAN-300 0.5 mg/kg QW		Cohort B - SAN-300 1.0 mg/kg QW		Cohort C - SAN-300 2.0 mg/kg QOW		Cohort D - SAN-300 4.0 mg/kg QOW		Cohort E - SAN-300 4.0 mg/kg QW		Placebo
Arm/Group Description	SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks		SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks		SAN-300 2.0 mg/kg subcutaneous every other week for six weeks		SAN-300 4.0 mg/kg subcutaneous once every other week for six weeks		SAN-300 4.0 mg/kg subcutaneous every week for six weeks		Placebo dosing
All Cause Mortality
	Cohort A - SAN-300 0.5 mg/kg QW		Cohort B - SAN-300 1.0 mg/kg QW		Cohort C - SAN-300 2.0 mg/kg QOW		Cohort D - SAN-300 4.0 mg/kg QOW		Cohort E - SAN-300 4.0 mg/kg QW		Placebo
	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	0/6 (0%)		0/7 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/10 (0%)
Serious Adverse Events
	Cohort A - SAN-300 0.5 mg/kg QW		Cohort B - SAN-300 1.0 mg/kg QW		Cohort C - SAN-300 2.0 mg/kg QOW		Cohort D - SAN-300 4.0 mg/kg QOW		Cohort E - SAN-300 4.0 mg/kg QW		Placebo
	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	0/6 (0%)		0/7 (0%)		0/6 (0%)		2/6 (33.3%)		0/6 (0%)		0/10 (0%)
Musculoskeletal and connective tissue disorders
Flank Pain	0/6 (0%)		0/7 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/10 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma	0/6 (0%)		0/7 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Cohort A - SAN-300 0.5 mg/kg QW		Cohort B - SAN-300 1.0 mg/kg QW		Cohort C - SAN-300 2.0 mg/kg QOW		Cohort D - SAN-300 4.0 mg/kg QOW		Cohort E - SAN-300 4.0 mg/kg QW		Placebo
	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	1/6 (16.7%)		1/7 (14.3%)		1/6 (16.7%)		6/6 (100%)		2/6 (33.3%)		3/10 (30%)
Blood and lymphatic system disorders
anaemia	0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/10 (0%)
Gastrointestinal disorders
diarrheoa	0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/10 (10%)
Mouth Ulcerations	1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/10 (0%)
Nausea	0/6 (0%)		0/7 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		2/10 (20%)
Vomiting	0/6 (0%)		0/7 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/10 (10%)
General disorders
Chills	0/6 (0%)		0/7 (0%)		0/6 (0%)		3/6 (50%)		0/6 (0%)		0/10 (0%)
Injection Site Rash	0/6 (0%)		0/7 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/10 (0%)
Injection Site Reaction	0/6 (0%)		0/7 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/10 (0%)
Pyrexia	0/6 (0%)		0/7 (0%)		0/6 (0%)		3/6 (50%)		0/6 (0%)		0/10 (0%)
Infections and infestations
Nasopharyngitis	0/6 (0%)		0/7 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/10 (0%)
Upper Respiratory Tract Infection	0/6 (0%)		0/7 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/10 (10%)
Investigations
Blood Pressure Increase	0/6 (0%)		0/7 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/10 (0%)
Electrocardiogram Abnormal	0/6 (0%)		0/7 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/10 (10%)
Nervous system disorders
Dizziness	0/6 (0%)		0/7 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/10 (10%)
Headaches	0/6 (0%)		0/7 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/6 (16.7%)		1/10 (10%)
Syncope	0/6 (0%)		0/7 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/10 (10%)
Tremor	0/6 (0%)		0/7 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.