Clinical trial NCT02148744: 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
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®7195
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Allergic Conjunctivitis
Atopic Dermatitis
Lead sponsor: Xencor, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Number of adverse events including type and severity
timeFrame: Date of randomization up to Day 43
measure: Number of adverse events including type and severity of a priming IV dose followed by an escalating second IV dose
timeFrame: Date of randomization up to Day 36
Secondary outcomes:
measure: Blood concentration of XmAb7195 and blood levels of human anti-human antibodies after single-dose IV administration of XmAb7195
timeFrame: Time of dosing up to Day 43
measure: 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
timeFrame: Time of dosing up to Day 36
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Parexel Baltimore Early Phase Clinical Unit
state: Maryland
Study officials:
affiliation: Parexel Baltimore Early Phase Clinical Unit
name: Ronald Goldwater, MD
role: PRINCIPAL_INVESTIGATOR
References: