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

Xencor

Status and phase

Completed

Phase 1

Conditions

Atopic Dermatitis

Allergic Conjunctivitis

Allergic Rhinitis

Treatments

Biological: Placebo

Biological: XmAb7195

Study type

Interventional

Funder types

Industry

Identifiers

NCT02148744

XmAb7195-01

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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;