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OpenTrials
Completed

NCT Number: NCT02148744

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

XmAb7195

Biological

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

Placebo

Biological

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Xencor, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blinded, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®7195

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 28, 2014
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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