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
This trial is active, not recruiting.
|Conditions||allergic rhinitis, allergic conjunctivitis, atopic dermatitis|
|Start date||May 2014|
|End date||March 2016|
|Trial size||72 participants|
|Trial identifier||NCT02148744, XmAb7195-01|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Number of adverse events including type and severity
time frame: Date of randomization up to Day 43
Number of adverse events including type and severity of a priming IV dose followed by an escalating second IV dose
time frame: Date of randomization up to Day 36
Blood concentration of XmAb7195 and blood levels of human anti-human antibodies after single-dose IV administration of XmAb7195
time frame: Time of dosing up to Day 43
Blood concentration of XmAb7195 and blood levels of human anti-human antibodies after a priming IV dose followed by an escalating second IV dose of XmAb7195
time frame: Time of dosing up to Day 36
Male or female participants from 18 years up to 50 years old.
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;
|Official title||A Randomized, Double-Blinded, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®7195|
|Principal investigator||Ronald Goldwater, MD|
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