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

Completed · Phase 1 · Has a placebo group

Conditions studied: Allergic Rhinitis, Allergic Conjunctivitis, Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT02148744

Run by

Xencor, Inc.

People needed

72

Starts

2014-05-01

Expected to finish

2015-09-21

Last updated by the study team

2017-01-24

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Parexel Baltimore Early Phase Clinical Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.