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Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)

Sponsor
Aridis Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01589185
Collaborator
(none)
48
Enrollment
18
Locations
5
Arms
52
Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this study are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in addition of standard of care antibiotic treatment.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

  1. aureus is a leading cause of bloodstream, skin, soft tissue, and lower respiratory tract infections worldwide. The frequencies of both nosocomial and community-acquired S. aureus infections have increased steadily over the years and the treatment of these infections has become more challenging due to the emergence of multi-drug resistant strains (e.g. methicillin-resistant Staphylococcus aureus).

  2. aureus has several virulence factors that contribute to the pathogenesis of the infection. Amongst them, alpha-toxin that is involved in the pathogenesis of pneumonia, as it leads to apoptosis and cell lysis, in particular lymphocytes, macrophages, alveolar epithelial cells, pulmonary endothelium, and thrombocytes.

In spite of preventive measures for S. aureus infections and current medical treatment (mostly antibiotic therapy, alone or in combination), there is a clear unmet medical need in the clinic for additional treatment options. Passive immunotherapy with monoclonal antibodies may improve treatment options for severe and life-threatening infections like those caused by

  1. aureus.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, Efficacy and Pharmacodynamics of KBSA301 in Severe Pneumonia (S. Aureus)
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: KBSA301, a monoclonal antibody dose 1

1 mg/kg KBSA301

Drug: KBSA301
KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
Other Names:
  • AR301

    		•
    Experimental: KBSA301, a monoclonal antibody dose 2

    3 mg/kg KBSA301

    Drug: KBSA301
    KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
    Other Names:
  • AR301

    		•
    Experimental: KBSA301, a monoclonal antibody dose 3

    10 mg/kg KBSA301

    Drug: KBSA301
    KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
    Other Names:
  • AR301

    		•
    Experimental: KBSA301, a monoclonal antibody dose 4

    20 mg/kg KBSA301

    Drug: KBSA301
    KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
    Other Names:
  • AR301

    		•
    Experimental: Placebo

    KBSA301-placebo

    Drug: Placebo
    Placebo administered as a single intravenous infusion
    Other Names:
  • Placebo KBSA301

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy Endpoint: All-Cause Mortality by Day 28 [At Day 28 post infusion (Day 0)]

      A summary of the number (%) of patients who died on or before Day 28 (mITT population) is provided, by treatment group and overall.

    Secondary Outcome Measures

    1. Efficacy: All-Cause Mortality (End Of Study [EOS]) [Patients who died during the specified timepoints (by EOS), up to day 107]

      A summary of the number (%) of patients who died on or before timepoints Day EOS (mITT population) is provided, by treatment group (overall) and placebo.

    2. Efficacy: All-Cause Mortality (Day 14) [Patients who died during the specified timepoints (Day 14)]

      A summary of the number (%) of patients who died on or before timepoints Day 14 visit (mITT population) is provided, by treatment group (overall) and placebo.

    3. Efficacy: All-Cause Mortality (Day 7) [Patients who died during the specified timepoints (Day 7)]

      A summary of the number (%) of patients who died on or before timepoints Day 7 visit (mITT population) is provided, by treatment group (overall) and placebo.

    4. Efficacy: All-Cause Mortality (Day 21) [Patients who died during the specified timepoints (Day 21)]

      A summary of the number (%) of patients who died on or before timepoints Day 21 visit (mITT population) is provided, by treatment group (overall) and placebo.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult male or female patients ≥ 18 years and ≤ 70 years of age

    • Severe pneumonia caused by S. aureus (either methicillin-resistant or methicillin-sensitive) managed in an ICU

    • APACHE II of ≤30 at the time of diagnosis

    • Identification of S. aureus

    • Written informed consent provided by the patient, the relatives or the designated trusted person and/or according to local guidelines

    Exclusion Criteria:

    • Women of child bearing potential are excluded from the participation from the study unless they have a negative pregnancy test at baseline and during the course of the study. Postmenopausal women or females that have been surgically sterilized are allowed to participate.

    • Hypersensitivity to excipients or to any prescribed medication

    • Severe neutropenia, lymphoma or anticipated chemotherapy

    • Patients who have long-term tracheostomy

    • Current or recent investigational drug (within 30 days of enrollment, or 5 half-lives of the investigational compound, whichever is longer)

    • Presence of meningitis, endocarditis, or osteomyelitis

    • Acquired immune deficiency syndrome (AIDS) with cluster of differentiation 4 (CD4) count <200 cells/ml

    • Known bronchial obstruction or a history of post-obstructive pneumonia.

    • Active primary lung cancer or another malignancy metastatic to the lungs

    • Cystic fibrosis, known or suspected Pneumocystis jiroveci pneumonia, or known or suspected active tuberculosis

    • Immunosuppressive therapy

    • Liver function deficiency

    • Moribund clinical condition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 83 Jacksonville Florida United States 32209
    2 Site 81 Oklahoma City Oklahoma United States 73104
    3 Site 80 Houston Texas United States 77030
    4 Site 11 Brussels Belgium
    5 Site 16 Liege Belgium
    6 Site 41 Angers France
    7 Site 40 Angouleme France
    8 Site 32 Argenteuil France
    9 Site 34 Colombes France
    10 Site 36 Dijon France
    11 Site 35 La Roche Sur Yon France
    12 Site 31 Limoges France
    13 Site 39 Lyon France
    14 Site 37 Nantes France
    15 Site 38 Orleans France
    16 Site 33 Tours France
    17 Site 51 Barcelona Spain
    18 Site 52 Barcelona Spain

    Sponsors and Collaborators

    • Aridis Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Pierre-François M Laterre, MD, Université catholique de Louvain, Brussels, Belgium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aridis Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT01589185
    Other Study ID Numbers:
    • KBSA301-001
    First Posted:
    May 1, 2012
    Last Update Posted:
    Apr 24, 2020
    Last Verified:
    Mar 1, 2020
    Keywords provided by Aridis Pharmaceuticals, Inc.
    Pneumonia
    Monoclonal antibody
    Staphylococcus aureus
    Additional relevant MeSH terms:
    Pneumonia
    Pneumonia, Staphylococcal

    Study Results

    Participant Flow

    Recruitment Details Recruitment locations: Intensive Care Units. First subject enrolled: 16-May-2012. Last subject completed: 06-Sep-2016. The study was on administrative hold from 20-Nov-2012 to 24-Dec-2014.
    Pre-assignment Detail Eligible patients were randomized based on evidence of severe pneumonia caused by S. aureus. All patients enrolled were intubated.
    Arm/Group Title KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo
    Arm/Group Description 1 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 3 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 10 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 20 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. KBSA301-placebo Placebo: Placebo administered as a single intravenous infusion
    Period Title: Overall Study
    STARTED 6 8 10 8 16
    COMPLETED 4 6 6 5 15
    NOT COMPLETED 2 2 4 3 1

    Baseline Characteristics

    Arm/Group Title KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo Total
    Arm/Group Description 1 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 3 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 10 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 20 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. KBSA301-placebo Placebo: Placebo administered as a single intravenous infusion Total of all reporting groups
    Overall Participants 6 8 10 8 16 48
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    3
    50%
    7
    87.5%
    5
    50%
    4
    50%
    12
    75%
    31
    64.6%
    >=65 years
    3
    50%
    1
    12.5%
    5
    50%
    4
    50%
    4
    25%
    17
    35.4%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    64.7
    (9.97)
    49.1
    (17.02)
    61.5
    (10.30)
    60.6
    (13.62)
    52.1
    (16.23)
    56.6
    (14.77)
    Sex: Female, Male (Count of Participants)
    Female
    2
    33.3%
    0
    0%
    4
    40%
    1
    12.5%
    3
    18.8%
    10
    20.8%
    Male
    4
    66.7%
    8
    100%
    6
    60%
    7
    87.5%
    13
    81.3%
    38
    79.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    1
    10%
    0
    0%
    0
    0%
    1
    2.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    6
    100%
    8
    100%
    9
    90%
    8
    100%
    15
    93.8%
    46
    95.8%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.3%
    1
    2.1%
    Region of Enrollment (participants) [Number]
    Belgium
    0
    0%
    0
    0%
    1
    10%
    0
    0%
    0
    0%
    1
    2.1%
    United States
    0
    0%
    0
    0%
    0
    0%
    1
    12.5%
    0
    0%
    1
    2.1%
    France
    4
    66.7%
    8
    100%
    9
    90%
    6
    75%
    16
    100%
    43
    89.6%
    Spain
    2
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    4.2%
    United Kingdom
    0
    0%
    0
    0%
    0
    0%
    1
    12.5%
    0
    0%
    1
    2.1%
    Type of Pneumonia (Count of Participants)
    CABP
    1
    16.7%
    3
    37.5%
    0
    0%
    1
    12.5%
    4
    25%
    9
    18.8%
    VABP
    5
    83.3%
    4
    50%
    7
    70%
    5
    62.5%
    5
    31.3%
    26
    54.2%
    HABP
    0
    0%
    1
    12.5%
    3
    30%
    2
    25%
    7
    43.8%
    13
    27.1%
    Type of S. aureus Infection (Count of Participants)
    MRSA
    2
    33.3%
    0
    0%
    0
    0%
    2
    25%
    2
    12.5%
    6
    12.5%
    MSSA
    4
    66.7%
    8
    100%
    9
    90%
    6
    75%
    14
    87.5%
    41
    85.4%
    Not confirmed
    0
    0%
    0
    0%
    1
    10%
    0
    0%
    0
    0%
    1
    2.1%
    BMI (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    32.6
    (9.14)
    28.1
    (7.3)
    31.1
    (6.15)
    29.1
    (3.88)
    26.8
    (5.39)
    29.0
    (6.32)
    Pa02/Fi02 Ratio (ratio) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [ratio]
    146.7
    (30.7)
    173.7
    (38.36)
    138.8
    (53.56)
    148.4
    (34.49)
    140.7
    (40.7)
    147.8
    (41.32)
    SOFA Score (units on a scale (score)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale (score)]
    6.8
    (1.64)
    8.8
    (3.45)
    5.6
    (1.51)
    6.8
    (1.72)
    6.8
    (2.86)
    6.9
    (2.62)
    APACHE II Score (units on a scale (score)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale (score)]
    18.3
    (3.01)
    21.5
    (5.21)
    17.9
    (4.15)
    19.5
    (3.7)
    17.5
    (4.9)
    18.7
    (4.48)
    CPIS Score (units on a scale (score)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale (score)]
    8.3
    (1.63)
    9.6
    (2.26)
    9.6
    (2.26)
    9.6
    (3.7)
    9.8
    (1.28)
    9.6
    (1.58)

    Outcome Measures

    1. Primary Outcome
    Title Efficacy Endpoint: All-Cause Mortality by Day 28
    Description A summary of the number (%) of patients who died on or before Day 28 (mITT population) is provided, by treatment group and overall.
    Time Frame At Day 28 post infusion (Day 0)

    Outcome Measure Data

    Analysis Population Description
    The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.
    Arm/Group Title KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo All Treatment Group
    Arm/Group Description 1 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 3 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 10 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 20 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. KBSA301-placebo Placebo: Placebo administered as a single intravenous infusion Sum of all four KBSA301 treatment groups (1 mg/kg, 3 mg/kg, 10 mg/kg and 20 mg/kg)
    Measure Participants 6 8 9 8 16 31
    Count of Participants [Participants]
    1
    16.7%
    2
    25%
    2
    20%
    0
    0%
    0
    0%
    5
    10.4%
    2. Secondary Outcome
    Title Efficacy: All-Cause Mortality (End Of Study [EOS])
    Description A summary of the number (%) of patients who died on or before timepoints Day EOS (mITT population) is provided, by treatment group (overall) and placebo.
    Time Frame Patients who died during the specified timepoints (by EOS), up to day 107

    Outcome Measure Data

    Analysis Population Description
    The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.
    Arm/Group Title KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo
    Arm/Group Description 1 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 3 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 10 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 20 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. KBSA301-placebo Placebo: Placebo administered as a single intravenous infusion
    Measure Participants 6 8 9 8 16
    Died on or before EOS
    1
    16.7%
    2
    25%
    2
    20%
    0
    0%
    1
    6.3%
    Survived on or before EOS
    5
    83.3%
    6
    75%
    7
    70%
    8
    100%
    15
    93.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection KBSA301, a Monoclonal Antibody Dose 1, KBSA301, a Monoclonal Antibody Dose 2, KBSA301, a Monoclonal Antibody Dose 3, KBSA301, a Monoclonal Antibody Dose 4, Placebo
    Comments The number (%) of patients who died on or before end of study (EOS) was compared among all 5 groups. The mITT population was used.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3962
    Comments < 0.1 is considered borderline significant
    Method Fisher Exact
    Comments
    3. Secondary Outcome
    Title Efficacy: All-Cause Mortality (Day 14)
    Description A summary of the number (%) of patients who died on or before timepoints Day 14 visit (mITT population) is provided, by treatment group (overall) and placebo.
    Time Frame Patients who died during the specified timepoints (Day 14)

    Outcome Measure Data

    Analysis Population Description
    The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.
    Arm/Group Title KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo
    Arm/Group Description 1 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 3 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 10 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 20 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. KBSA301-placebo Placebo: Placebo administered as a single intravenous infusion
    Measure Participants 6 8 9 8 16
    Died on or before Day 14
    1
    16.7%
    1
    12.5%
    0
    0%
    0
    0%
    0
    0%
    Survived on or before Day 14
    5
    83.3%
    7
    87.5%
    9
    90%
    8
    100%
    16
    100%
    4. Secondary Outcome
    Title Efficacy: All-Cause Mortality (Day 7)
    Description A summary of the number (%) of patients who died on or before timepoints Day 7 visit (mITT population) is provided, by treatment group (overall) and placebo.
    Time Frame Patients who died during the specified timepoints (Day 7)

    Outcome Measure Data

    Analysis Population Description
    The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.
    Arm/Group Title KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo
    Arm/Group Description 1 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 3 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 10 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 20 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. KBSA301-placebo Placebo: Placebo administered as a single intravenous infusion
    Measure Participants 6 8 9 8 16
    Died on or before Day 7
    0
    0%
    1
    12.5%
    0
    0%
    0
    0%
    0
    0%
    Survived on or before Day 7
    6
    100%
    7
    87.5%
    9
    90%
    8
    100%
    16
    100%
    5. Secondary Outcome
    Title Efficacy: All-Cause Mortality (Day 21)
    Description A summary of the number (%) of patients who died on or before timepoints Day 21 visit (mITT population) is provided, by treatment group (overall) and placebo.
    Time Frame Patients who died during the specified timepoints (Day 21)

    Outcome Measure Data

    Analysis Population Description
    The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.
    Arm/Group Title KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo
    Arm/Group Description 1 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 3 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 10 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 20 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. KBSA301-placebo Placebo: Placebo administered as a single intravenous infusion
    Measure Participants 6 8 9 8 16
    Died on or before Day 21
    1
    16.7%
    2
    25%
    1
    10%
    0
    0%
    0
    0%
    Survived on or before Day 21
    5
    83.3%
    6
    75%
    8
    80%
    8
    100%
    16
    100%

    Adverse Events

    Time Frame From time of treatment to day 107.
    Adverse Event Reporting Description Standard definitions were used.
    Arm/Group Title KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo
    Arm/Group Description 1 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 3 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 10 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. 20 mg/kg KBSA301 KBSA301: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. KBSA301-placebo Placebo: Placebo administered as a single intravenous infusion
    All Cause Mortality
    KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo
    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%) 2/8 (25%) 2/10 (20%) 0/8 (0%) 1/16 (6.3%)
    Serious Adverse Events
    KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/6 (50%) 4/8 (50%) 5/10 (50%) 1/8 (12.5%) 5/16 (31.3%)
    Blood and lymphatic system disorders
    Anaemia 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Heparin-induced thrombocytopenia 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Cardiac disorders
    Atrial flutter 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Cardiac arrest 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    General disorders
    Multi-organ failure 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Infections and infestations
    Pneumonia 0/6 (0%) 0 1/8 (12.5%) 1 1/10 (10%) 1 0/8 (0%) 0 2/16 (12.5%) 2
    Septic Shock 0/6 (0%) 0 2/8 (25%) 2 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Abscess neck 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Sepsis 0/6 (0%) 0 1/8 (12.5%) 1 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Bacteraemia 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Device related infection 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Incision site infection 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Tracheobronchitis 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Wound infection staphylococcal 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Injury, poisoning and procedural complications
    Post-procedural haemorrhage 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthritis 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Nervous system disorders
    Coma 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Peripheral motor neuropathy 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Renal and urinary disorders
    Renal failure acute 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Renal failure chronic 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Renal tubular necrosis 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/6 (0%) 0 1/8 (12.5%) 1 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Pleurisy 0/6 (0%) 0 1/8 (12.5%) 1 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Hypoventilation 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Lung disorder 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Pulmonary embolism 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Vascular disorders
    Shock hemorrhage 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Vena cava thrombosis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Other (Not Including Serious) Adverse Events
    KBSA301, a Monoclonal Antibody Dose 1 KBSA301, a Monoclonal Antibody Dose 2 KBSA301, a Monoclonal Antibody Dose 3 KBSA301, a Monoclonal Antibody Dose 4 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/6 (100%) 8/8 (100%) 10/10 (100%) 7/8 (87.5%) 15/16 (93.8%)
    Blood and lymphatic system disorders
    Anaemia 1/6 (16.7%) 1 3/8 (37.5%) 3 2/10 (20%) 2 1/8 (12.5%) 1 1/16 (6.3%) 1
    Cardiac disorders
    Atrial fibrillation 2/6 (33.3%) 2 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 2/16 (12.5%) 2
    Atrioventricular block 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Bradycardia 1/6 (16.7%) 1 2/8 (25%) 2 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Coronary artery stenosis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Sinus tachycardia 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Tachycardia 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 1/16 (6.3%) 1
    Ventricular tachycardia 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Ear and labyrinth disorders
    Ear haemorrhage 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Endocrine disorders
    Hypothyroidism 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Gastrointestinal disorders
    Abdominal distension 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Abdominal pain 0/6 (0%) 0 1/8 (12.5%) 2 0/10 (0%) 0 1/8 (12.5%) 1 1/16 (6.3%) 1
    Constipation 1/6 (16.7%) 1 3/8 (37.5%) 3 2/10 (20%) 2 0/8 (0%) 0 4/16 (25%) 4
    Diarrhoea 1/6 (16.7%) 1 2/8 (25%) 2 2/10 (20%) 3 1/8 (12.5%) 1 1/16 (6.3%) 1
    Duodenal ulcer 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 1/16 (6.3%) 1
    Dysphagia 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Gastric ulcer 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Gastrointestinal haemorrhage 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 2 0/8 (0%) 0 0/16 (0%) 0
    Internal hernia 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Localised intraabdominal fluid collection 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Melaena 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Nausea 0/6 (0%) 0 1/8 (12.5%) 1 1/10 (10%) 1 1/8 (12.5%) 1 0/16 (0%) 0
    Oesophagitis 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 1/16 (6.3%) 1
    Pancreatic cyst 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Retroperitoneal oedema 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Vomiting 0/6 (0%) 0 2/8 (25%) 3 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    General disorders
    Chest pain 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Generalised oedema 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Inflammation 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Infusion site phlebitis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Mucosal inflammation 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Oedema 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 2 1/8 (12.5%) 1 0/16 (0%) 0
    Pyrexia 1/6 (16.7%) 1 1/8 (12.5%) 1 1/10 (10%) 1 0/8 (0%) 0 1/16 (6.3%) 1
    Hepatobiliary disorders
    Cholestasis 0/6 (0%) 0 0/8 (0%) 0 2/10 (20%) 2 0/8 (0%) 0 2/16 (12.5%) 2
    Hepatic failure 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Hepatocellular injury 1/6 (16.7%) 1 3/8 (37.5%) 3 0/10 (0%) 0 0/8 (0%) 0 2/16 (12.5%) 2
    Ischaemic hepatitis 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Infections and infestations
    Abdominal wall abscess 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Acinetobacter bacteraemia 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Bacteraemia 0/6 (0%) 0 2/8 (25%) 3 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Brain abscess 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Bronchitis 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Bronchitis bacterial 0/6 (0%) 0 1/8 (12.5%) 1 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Candida infection 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Clostridium difficile infection 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Conjunctivitis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Encephalitis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Enterobacter infection 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Enterobacter tracheobronchitis 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Fungal infection 0/6 (0%) 0 2/8 (25%) 2 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Haematoma infection 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Herpes virus infection 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Incision site abscess 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Klebsiella bacteraemia 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Lymphangitis 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Mediastinitis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Nasopharyngitis 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Oral fungal infection 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Pancreatic abscess 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Pneumonia 1/6 (16.7%) 1 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Postoperative wound infection 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 1/8 (12.5%) 1 0/16 (0%) 0
    Severe acute respiratory syndrome 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Sinusitis 0/6 (0%) 0 2/8 (25%) 2 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Sinusitis bacterial 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Skin infection 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Urinary tract infection 0/6 (0%) 0 0/8 (0%) 0 5/10 (50%) 6 1/8 (12.5%) 1 3/16 (18.8%) 3
    Wound abscess 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Injury, poisoning and procedural complications
    Electrical burn 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Eschar 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Fall 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Subdural haematoma 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Investigations
    Alanine aminotransferase increased 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Blood glucose decreased 0/6 (0%) 0 1/8 (12.5%) 1 2/10 (20%) 3 0/8 (0%) 0 2/16 (12.5%) 2
    Blood glucose increased 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 2/16 (12.5%) 2
    Blood lactate dehydrogenase increased 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Blood magnesium decreased 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Blood phosphorus decreased 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 2/8 (25%) 2 0/16 (0%) 0
    Blood phosphorus increased 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Blood potassium decreased 1/6 (16.7%) 1 3/8 (37.5%) 3 3/10 (30%) 4 4/8 (50%) 4 0/16 (0%) 0
    Blood potassium increased 0/6 (0%) 0 2/8 (25%) 2 2/10 (20%) 2 0/8 (0%) 0 1/16 (6.3%) 1
    Blood sodium decreased 0/6 (0%) 0 2/8 (25%) 2 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Blood sodium increased 0/6 (0%) 0 1/8 (12.5%) 3 1/10 (10%) 1 0/8 (0%) 0 1/16 (6.3%) 1
    Carbon dioxide increased 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Eosinophil count increased 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Gamma-glutamyltransferase increased 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Hepatic enzyme increased 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 2 0/16 (0%) 0
    International normalised ratio increased 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Platelet count decreased 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Platelet count increased 0/6 (0%) 0 3/8 (37.5%) 3 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Prothrombin level abnormal 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Weight decreased 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    White blood cell count increased 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Metabolism and nutrition disorders
    Alkalosis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Cerebral salt-wasting syndrome 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Fluid overload 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Gout 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 1/8 (12.5%) 1 1/16 (6.3%) 1
    Hypernatraemia 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Hypoalbuminaemia 0/6 (0%) 0 1/8 (12.5%) 2 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Iron deficiency 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Malnutrition 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 2/8 (25%) 2 1/16 (6.3%) 1
    Metabolic acidosis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Metabolic alkalosis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Vitamin D deficiency 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 1/16 (6.3%) 1
    Musculoskeletal and connective tissue disorders
    Arthritis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Back pain 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Bursitis 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Musculoskeletal stiffness 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Rheumatoid arthritis 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasma cell myeloma 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Nervous system disorders
    Amnesia 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Aphonia 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Convulsion 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Headache 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 1/16 (6.3%) 1
    Memory impairment 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Quadriparesis 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Psychiatric disorders
    Agitation 0/6 (0%) 0 2/8 (25%) 2 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Anxiety 2/6 (33.3%) 2 1/8 (12.5%) 1 0/10 (0%) 0 1/8 (12.5%) 1 2/16 (12.5%) 2
    Confusional state 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 2/16 (12.5%) 2
    Depression 1/6 (16.7%) 1 1/8 (12.5%) 1 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Depressive symptom 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Initial insomnia 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Insomnia 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Renal and urinary disorders
    Haematuria 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Renal failure 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Renal failure acute 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Genital lesion 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Prostatitis 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 1/8 (12.5%) 1 1/16 (6.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 0/16 (0%) 0
    Bronchospasm 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Dysphonia 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Dyspnoea 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 1/8 (12.5%) 1 1/16 (6.3%) 1
    Epistaxis 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Haemothorax 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Hypoxia 0/6 (0%) 0 1/8 (12.5%) 1 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Laryngeal oedema 1/6 (16.7%) 1 0/8 (0%) 0 2/10 (20%) 2 1/8 (12.5%) 1 0/16 (0%) 0
    Pleural effusion 1/6 (16.7%) 1 0/8 (0%) 0 2/10 (20%) 4 0/8 (0%) 0 0/16 (0%) 0
    Pleurisy 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Pneumothorax 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Respiratory failure 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermatitis 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Dermatitis diaper 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Erythema 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Hyperhidrosis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Rash 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 3
    Skin ulcer 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Subcutaneous emphysema 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Vascular disorders
    Haemodynamic instability 0/6 (0%) 0 0/8 (0%) 0 1/10 (10%) 1 0/8 (0%) 0 0/16 (0%) 0
    Hypertension 1/6 (16.7%) 1 0/8 (0%) 0 1/10 (10%) 1 1/8 (12.5%) 1 3/16 (18.8%) 3
    Hypotension 1/6 (16.7%) 1 0/8 (0%) 0 0/10 (0%) 0 2/8 (25%) 2 2/16 (12.5%) 2
    Superior vena cava syndrome 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 0/16 (0%) 0
    Thrombosis 0/6 (0%) 0 0/8 (0%) 0 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1
    Venous thrombosis 0/6 (0%) 0 1/8 (12.5%) 1 0/10 (0%) 0 0/8 (0%) 0 1/16 (6.3%) 1

    Limitations/Caveats

    The study was not designed and not powered to demonstrate statistically significant differences between treatment groups. All efficacy results are descriptive and exploratory.

    More Information

    Certain Agreements

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

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Lynne Deans, M.T.
    Organization Aridis Pharmaceuticals, Inc.
    Phone 408-385-1742
    Email deansl@aridispharma.com
    Responsible Party:
    Aridis Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT01589185
    Other Study ID Numbers:
    • KBSA301-001
    First Posted:
    May 1, 2012
    Last Update Posted:
    Apr 24, 2020
    Last Verified:
    Mar 1, 2020