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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148744
• Other study ID #: XmAb7195-01
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2014
• Last updated: January 23, 2017
• Start date: May 2014
• Est. completion date: September 21, 2015

Study information

• Verified date: January 2017
• Source: Xencor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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;

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Allergic Rhinitis
• Atopic Dermatitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Rhinitis
• Rhinitis, Allergic

Intervention

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
• Placebo

Locations

Country	Name	City	State
United States	Parexel Baltimore Early Phase Clinical Unit	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Xencor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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