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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

Primary Purpose

Allergic Rhinitis, Allergic Conjunctivitis, Atopic Dermatitis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

XmAb7195

Placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

Parexel Baltimore Early Phase Clinical Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XmAb7195 or Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02148744

First Posted

May 19, 2014

Last Updated

January 23, 2017

Sponsor

Xencor, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02148744

Brief Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

September 21, 2015 (Actual)

Study Completion Date

September 21, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xencor, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis, Allergic Conjunctivitis, Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

XmAb7195 or Placebo

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

XmAb7195

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Number of adverse events including type and severity

Description

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

Time Frame

Date of randomization up to Day 43

Title

Number of adverse events including type and severity of a priming IV dose followed by an escalating second IV dose

Description

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

Time Frame

Date of randomization up to Day 36

Secondary Outcome Measure Information:

Title

Blood concentration of XmAb7195 and blood levels of human anti-human antibodies after single-dose IV administration of XmAb7195

Description

Pharmocokinetic (PK) analysis for levels of XmAb7195 will be determined in subjects blood from time of initial dosing up to Day 43

Time Frame

Time of dosing up to Day 43

Title

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

Description

Presence of human anti-human antibodies will be assessed from time of dosing up to Day 36

Time Frame

Time of dosing up to Day 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Goldwater, MD

Organizational Affiliation

Parexel Baltimore Early Phase Clinical Unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

Parexel Baltimore Early Phase Clinical Unit

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21225

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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