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

A Randomized, Double-Blinded, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®7195

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Atopic Dermatitis; Allergic Conjunctivitis
• Intervention / Treatment: Biological: Placebo; Biological: XmAb7195

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Parexel Baltimore Early Phase Clinical Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XmAb7195 or Placebo	Biological: Placebo; Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Xencor, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 21, 2015
• Study Completion (Actual): September 21, 2015

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 22, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Genetic Diseases, Inborn; Otorhinolaryngologic Diseases; Skin Diseases, Genetic; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Conjunctival Diseases; Skin Diseases, Eczematous; Dermatitis; Rhinitis; Rhinitis, Allergic; Eczema; Dermatitis, Atopic; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: XmAb7195-01