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KBSA301

Phase 1/2

Pneumonia Due to Staphylococcus Aureus | Small Molecules | Infectious Disease |Aridis Pharmaceuticals Inc.|Trials Updated: Apr 24, 2020

KBSA301 development status

Highest phase Phase 1/2
Registered trials 1 across 1 sponsor since May 2012

KBSA301 target and mechanism

ModalitySmall Molecules

Also known as AR301

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

KBSA301 clinical trials

KBSA301 · 1 trial · 1 indication

Phase 1/2 1
NCT01589185Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)Pneumonia Due to Staphylococcus Aureus
COMPLETED48 Analytics
PHASE1/PHASE2COMPLETED
Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)
Pneumonia Due to Staphylococcus Aureus
NCT0158918548
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Study Endpoints

Primary Endpoints

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 Endpoints

Efficacy: All-Cause Mortality (End Of Study [EOS])
Patients who died during the specified timepoints (by EOS), up to day 107
Efficacy: All-Cause Mortality (Day 14)
Patients who died during the specified timepoints (Day 14)
Efficacy: All-Cause Mortality (Day 7)
Patients who died during the specified timepoints (Day 7)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KBSA301, a monoclonal antibody dose 1EXPERIMENTAL1 mg/kg KBSA301
KBSA301, a monoclonal antibody dose 2EXPERIMENTAL3 mg/kg KBSA301
KBSA301, a monoclonal antibody dose 3EXPERIMENTAL10 mg/kg KBSA301
KBSA301, a monoclonal antibody dose 4EXPERIMENTAL20 mg/kg KBSA301
PlaceboEXPERIMENTALKBSA301-placebo

Interventions

NameTypeDescription
KBSA301DRUGKBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
PlaceboDRUGPlacebo administered as a single intravenous infusion
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites18

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 ...

Countries:United StatesBelgiumFranceSpain
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