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
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 64
Inclusion Criteria
- Subjects who are willing to forego other forms of experimental treatment during the study.
- 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 have the ability to complete all study assessments;
- ...
- Subjects who are willing to forego other forms of experimental treatment during the study.
- 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 have the ability to complete all study assessments;
- 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 Criteria
- 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 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;
- ...
- 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 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;
- Subjects who have received live vaccines ≤ 3 months from Screening;
- Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb7195;
- 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 do not agree to use medically acceptable methods of contraception (as defined in the protocol);
- Subjects with prior exposure to a monoclonal antibody;
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
- Subjects who are willing to forego other forms of experimental treatment during the study.
- 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 have the ability to complete all study assessments;
- ...
- Subjects who are willing to forego other forms of experimental treatment during the study.
- 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 have the ability to complete all study assessments;
- 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 Criteria
- 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 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;
- ...
- 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 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;
- Subjects who have received live vaccines ≤ 3 months from Screening;
- Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb7195;
- 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 do not agree to use medically acceptable methods of contraception (as defined in the protocol);
- Subjects with prior exposure to a monoclonal antibody;
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
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