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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

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ClinicalTrials.gov Identifier: NCT02148744
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Xencor, Inc.

Brief Summary:
This first-in-human (FIH) study is a randomized, double-blinded, placebo-controlled, ascending dose study to investigate the safety, tolerability, and pharmacokinetics of XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Allergic Conjunctivitis Atopic Dermatitis Biological: XmAb7195 Biological: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®7195
Study Start Date : May 2014
Actual Primary Completion Date : September 21, 2015
Actual Study Completion Date : September 21, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: XmAb7195 or Placebo Biological: XmAb7195
Part 1 and 2: Single IV infusion of XmAb7195 or placebo Part 3: Two-dose sequential IV infusion of XmAb7195 or placebo on Day 1 and Day 8

Biological: Placebo



Primary Outcome Measures :
  1. Number of adverse events including type and severity [ Time Frame: 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

  2. Number of adverse events including type and severity of a priming IV dose followed by an escalating second IV dose [ Time Frame: 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 Outcome Measures :
  1. Blood concentration of XmAb7195 and blood levels of human anti-human antibodies after single-dose IV administration of XmAb7195 [ Time Frame: Time of dosing up to Day 43 ]
    Pharmocokinetic (PK) analysis for levels of XmAb7195 will be determined in subjects blood from time of initial dosing up to Day 43

  2. Blood concentration of XmAb7195 and blood levels of human anti-human antibodies after a priming IV dose followed by an escalating second IV dose of XmAb7195 [ Time Frame: Time of dosing up to Day 36 ]
    Presence of human anti-human antibodies will be assessed from time of dosing up to Day 36



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult males and females 18 to 50 years of age
  • Parts 1 and 3: Healthy subjects with no clinically significant abnormality identified on medical or laboratory evaluation and no history of any clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
  • Part 2: Otherwise healthy male and female subjects with a history of allergic rhinitis and/or allergic conjunctivitis and/or atopic dermatitis with an elevated serum IgE
  • Subjects who are able and willing to give written informed consent;
  • Subjects who have the ability to complete all study assessments;
  • Subjects who are willing to forego other forms of experimental treatment during the study.

Exclusion Criteria:

  • Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases, or disorders (other than allergic rhinitis and/or conjunctivitis and/or atopic dermatitis in Part 2) that would pose a significant risk to subject safety or significantly interfere with the study evaluation, procedures, or completion
  • Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody and/or human immunodeficiency virus (HIV) Type I or Type II tests at Screening;
  • Subjects who do not agree to use medically acceptable methods of contraception (as defined in the protocol);
  • Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb7195;
  • Subjects who have used any investigational drug in any clinical trial within 8 weeks prior to admission (Day -1), or have used an experimental monoclonal antibody;
  • Subjects with prior exposure to a monoclonal antibody;
  • Subjects with a history of anaphylaxis;
  • Subjects who have received live vaccines ≤ 3 months from Screening;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148744


Locations
United States, Maryland
Parexel Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Xencor, Inc.
Investigators
Principal Investigator: Ronald Goldwater, MD Parexel Baltimore Early Phase Clinical Unit

Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT02148744     History of Changes
Other Study ID Numbers: XmAb7195-01
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Dermatitis
Rhinitis
Rhinitis, Allergic
Dermatitis, Atopic
Eczema
Conjunctivitis
Conjunctivitis, Allergic
Skin Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Conjunctival Diseases
Eye Diseases