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XmAb7195

Phase 1

Allergic Rhinitis | Monoclonal antibody | Ophthalmology |Xencor, Inc.|Last Updated: Jul 11, 2017

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical trial landscape

XmAb7195 · 2 trials · 5 indications

Phase 1 2
NCT02881853Safety, Tolerability, and Bioavailability of Subcutaneously Administered XmAb®7195Healthy Volunteers
COMPLETED57 Analytics
NCT02148744Safety and Tolerability of XmAb®7195 in Adult Healthy Volunteers and Adult Subjects With a History of Allergic Rhinitis and/or Allergic Conjunctivitis and/or Atopic DermatitisAllergic Rhinitis
COMPLETED72 Analytics
PHASE1COMPLETED
Safety, Tolerability, and Bioavailability of Subcutaneously Administered XmAb®7195
Healthy Volunteers
NCT0288185357
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PHASE1COMPLETED
Safety and Tolerability of XmAb®7195 in Adult Healthy Volunteers and Adult Subjects With a History of Allergic Rhinitis and/or Allergic Conjunctivitis and/or Atopic Dermatitis
Allergic Rhinitis
NCT0214874472
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Study Endpoints
Primary Endpoints
Bioavailability of SC XmAb7195 after 4 once-weekly doses as measured by the ratio of dose-normalized SC XmAb7195 area under the concentration-time curve (AUC) to dose-normalized IV XmAb7195 AUC.
Date of randomization up to Day 50
Number of adverse events including type and severity
Date of randomization up to Day 43

Number, type and severity of adverse events, vital signs, electrocardiogram (ECGs), laboratory tests, and physical examinations will be reported during the study from randomization up to Day 43

Number of adverse events including type and severity of a priming IV dose followed by an escalating second IV dose
Date of randomization up to Day 36

Number, type and severity of adverse events, vital signs, electrocardiogram (ECGs), laboratory tests, and physical examinations will be reported during the study from randomization up to Day 36

Secondary Endpoints
Cmax, Maximum observed serum concentration
Date of randomization up to Day 50
Time at which Cmax was observed [Tmax]
Date of randomization up to Day 50
Area Under the Curve (AUC)
Date of randomization up to Day 50
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A1EXPERIMENTALXmAb7195 for IV infusion; dose level 1; 4 once-weekly doses
Part A2EXPERIMENTALXmAb7195 for SC injection; dose level 1; 4 once weekly doses
Part A3EXPERIMENTALXmAb7195 for SC injection; dose level 2; 4 once weekly doses
Part A4EXPERIMENTALXmAb7195 for SC injection; dose level 3; 4 once weekly doses
Part A5EXPERIMENTALXmAb7195 for SC injection; dose level 4; 4 once weekly doses
Part B6EXPERIMENTALXmAb7195 or placebo for SC injection; dose level 5; 4 once-weekly doses
Part B7EXPERIMENTALXmAb7195 or placebo for SC injection; dose level 6; 4 once-weekly doses
Part B8EXPERIMENTALXmAb7195 or placebo for SC injection; dose level 7; 4 once-weekly doses
Part B9EXPERIMENTALXmAb7195 or placebo for SC injection dose level 8; 4 once-weekly doses
XmAb7195 or PlaceboEXPERIMENTAL -
Interventions
NameTypeDescription
XmAb7195DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: All Subjects: * Male or female between 18 to 60 years of age (inclusive at the time of screening). * Total body weight 50.0 to 100.0 kg, and body mass index (BMI) 19.0 to 35.0 kg/m2 (inclusive, at screening). * Women can be of either childbearing or non-childbearing potential. ...

Countries:United States
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Competitive Landscape -Allergic Rhinitis 4 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY1PHASE3LY3650150, Standard therapy for INCS
Polyrizon Ltd.PLRZ1N/AUndisclosed
Regeneron Pharmaceuticals, Inc.REGN1 - Undisclosed
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