Atopic Dermatitis Clinical Trial
Official title:
A Randomized, Double-Blinded, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®7195
Verified date | January 2017 |
Source | Xencor, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | September 21, 2015 |
Est. primary completion date | September 21, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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; |
Country | Name | City | State |
---|---|---|---|
United States | Parexel Baltimore Early Phase Clinical Unit | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Xencor, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of adverse events including type and severity | Number, type and severity of adverse events, vital signs, electrocardiogram (ECGs), laboratory tests, and physical examinations will be reported during the study from randomization up to Day 43 | Date of randomization up to Day 43 | |
Primary | Number of adverse events including type and severity of a priming IV dose followed by an escalating second IV dose | Number, type and severity of adverse events, vital signs, electrocardiogram (ECGs), laboratory tests, and physical examinations will be reported during the study from randomization up to Day 36 | Date of randomization up to Day 36 | |
Secondary | Blood concentration of XmAb7195 and blood levels of human anti-human antibodies after single-dose IV administration of XmAb7195 | Pharmocokinetic (PK) analysis for levels of XmAb7195 will be determined in subjects blood from time of initial dosing up to Day 43 | Time of dosing up to Day 43 | |
Secondary | 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 | Presence of human anti-human antibodies will be assessed from time of dosing up to Day 36 | Time of dosing up to Day 36 |
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