Overview

This trial is active, not recruiting.

Conditions allergic rhinitis, allergic conjunctivitis, atopic dermatitis
Treatments xmab7195, placebo
Phase phase 1
Sponsor Xencor, Inc.
Start date May 2014
End date March 2016
Trial size 72 participants
Trial identifier NCT02148744, XmAb7195-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
xmab7195
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
placebo

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

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;

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Xencor, Inc..