Recruitment

Recruitment Status
Completed
Estimated Enrollment
64

Inclusion Criterias

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

Exclusion Criterias

Subjects with prior exposure to a monoclonal antibody;
Subjects who have received live vaccines ≤ 3 months from Screening;
Subjects who do not agree to use medically acceptable methods of contraception (as defined in the protocol);
...
Subjects with prior exposure to a monoclonal antibody;
Subjects who have received live vaccines ≤ 3 months from Screening;
Subjects who do not agree to use medically acceptable methods of contraception (as defined in the protocol);
Subjects with a history of anaphylaxis;
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 have used any investigational drug in any clinical trial within 8 weeks prior to admission (Day -1), or have used an experimental monoclonal antibody;
Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb7195;
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;

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 Criterias

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

Exclusion Criterias

Subjects with prior exposure to a monoclonal antibody;
Subjects who have received live vaccines ≤ 3 months from Screening;
Subjects who do not agree to use medically acceptable methods of contraception (as defined in the protocol);
...
Subjects with prior exposure to a monoclonal antibody;
Subjects who have received live vaccines ≤ 3 months from Screening;
Subjects who do not agree to use medically acceptable methods of contraception (as defined in the protocol);
Subjects with a history of anaphylaxis;
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 have used any investigational drug in any clinical trial within 8 weeks prior to admission (Day -1), or have used an experimental monoclonal antibody;
Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb7195;
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;

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