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

NCT02148744 | Completed Phase 1

• 1 other identifier: XmAb7195-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis; Allergic Conjunctivitis; Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

XmAb7195 or Placebo

EXPERIMENTAL

Biological: XmAb7195; Biological: Placebo

Interventions

XmAb7195 BIOLOGICAL

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

XmAb7195 or Placebo

Placebo BIOLOGICAL

XmAb7195 or Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xencor, Inc.: lead

Study Sites (1)

Parexel Baltimore Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Conjunctivitis, Allergic; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Ronald Goldwater, MD

  Parexel Baltimore Early Phase Clinical Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: September 21, 2015
• Study Completion: September 21, 2015
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (1)