Recruitment

Recruitment Status
Completed
Estimated Enrollment
64

Inclusion Criteria

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
Adult males and females 18 to 50 years of age
Subjects who have the ability to complete all study assessments;
...
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
Adult males and females 18 to 50 years of age
Subjects who have the ability to complete all study assessments;
Subjects who are able and willing to give written informed consent;
Subjects who are willing to forego other forms of experimental treatment during the study.
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;

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 with prior exposure to a monoclonal antibody;
...
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 with prior exposure to a monoclonal antibody;
Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb7195;
Subjects who do not agree to use medically acceptable methods of contraception (as defined in the protocol);
Subjects who have received live vaccines ≤ 3 months from Screening;
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 a history of anaphylaxis;

Summary

Conditions
  • Allergic Conjunctivitis
  • Allergic Rhinitis
  • Atopic Dermatitis
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 50 years
Gender
Both males and females

Inclusion Criteria

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
Adult males and females 18 to 50 years of age
Subjects who have the ability to complete all study assessments;
...
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
Adult males and females 18 to 50 years of age
Subjects who have the ability to complete all study assessments;
Subjects who are able and willing to give written informed consent;
Subjects who are willing to forego other forms of experimental treatment during the study.
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;

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 with prior exposure to a monoclonal antibody;
...
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 with prior exposure to a monoclonal antibody;
Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb7195;
Subjects who do not agree to use medically acceptable methods of contraception (as defined in the protocol);
Subjects who have received live vaccines ≤ 3 months from Screening;
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 a history of anaphylaxis;

Locations

Baltimore, Maryland, 21225
Baltimore, Maryland, 21225

Tracking Information

NCT #
NCT02148744
Collaborators
Not Provided
Investigators
  • Principal Investigator: Ronald Goldwater, MD Parexel Baltimore Early Phase Clinical Unit
  • Ronald Goldwater, MD Parexel Baltimore Early Phase Clinical Unit