Allergic Conjunctivitis, Allergic Rhinitis, Atopic Dermatitis
Conditions
Brief summary
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.
Interventions
BIOLOGICALXmAb7195
Part 1 and 2: Single IV infusion of XmAb7195 or placebo Part 3: Two-dose sequential IV infusion of XmAb7195 or placebo on Day 1 and Day 8
BIOLOGICALPlacebo
Sponsors
Xencor, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events including type and severity | Date of randomization up to Day 43 | 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 |
| Number of adverse events including type and severity of a priming IV dose followed by an escalating second IV dose | Date of randomization up to Day 36 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood concentration of XmAb7195 and blood levels of human anti-human antibodies after single-dose IV administration of XmAb7195 | Time of dosing up to Day 43 | Pharmocokinetic (PK) analysis for levels of XmAb7195 will be determined in subjects blood from time of initial 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 of dosing up to Day 36 | Presence of human anti-human antibodies will be assessed from time of dosing up to Day 36 |
Countries
United States
Outcome results
None listed