- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02881853
Safety, Tolerability, and Bioavailability of Subcutaneously Administered XmAb®7195
July 6, 2017 updated by: Xencor, Inc.
This is a Phase 1b, combined multiple dose subcutaneous (SC) bioavailability (BA) and multiple ascending dose (MAD) study evaluating safety, tolerability and BA of SC XmAb7195 in healthy subjects and in subjects with atopic disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will be divided into 2 parts.
Part A will be an open-label, parallel group, BA study evaluating 4 once-weekly doses of IV XmAb7195 or SC XmAb7195 in healthy subjects.
Each of 5 treatment groups will consist of 6 subjects.
Part B will commence following the completion of Part A and will be a randomized, double-blind, placebo-controlled, MAD study evaluating 4 once weekly doses of SC XmAb7195 in healthy subjects and/or subjects with atopic disease.
Each treatment group will consist of 8 subjects randomized 3:1 to XmAb7195:placebo Subjects in both parts of the study will be followed for at least 28 days after their last dose.
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78209
- ICON Early Phase Services, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
All Subjects:
- Male or female between 18 to 60 years of age (inclusive at the time of screening).
- Total body weight 50.0 to 100.0 kg, and body mass index (BMI) 19.0 to 35.0 kg/m2 (inclusive, at screening).
- Women can be of either childbearing or non-childbearing potential.
- Must be healthy 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 or interfere with the study evaluation, procedures, or completion as assessed by the Investigator.
Subjects with Atopic Disease Only (Part B):
- Allergen skin test reactivity of ≥ 5 mm wheal greater than saline control to any 2 of the following 5 allergens: D. pteronyssinus, D. farina, ragweed, Virginia live oak, and mountain cedar within 21 days prior to dosing.
- Sufficient clinical control of subject's atopic disease such that, in the opinion of the Investigator, the subject is unlikely to require substantial changes in therapy medication for the duration of the trial and unlikely to require the addition of an exclusionary medication
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 that would pose a significant risk to subject's safety or significantly interfere with the study evaluation, procedures, or completion as assessed by the Investigator.
- Subjects with platelet count < 150 k/uL at screening or at the time of initial admission.
- Subjects with peak expiratory flow rate < 400 L/min for males and < 350 L/min for females.
- Subjects with conditions associated with high risk of bleeding such as: past history of intracranial or gastrointestinal bleeding, hemorrhagic condition including hereditary or acquired bleeding, or coagulation disorder.
- Subjects with history of any clinically significant cardiovascular event such as: myocardial infarction, acute coronary syndrome, stroke, pulmonary embolism, and/or deep venous thrombosis.
- Subjects who do not agree to use medically acceptable methods of contraception (as defined in the protocol).
- Subjects who are pregnant or breast feeding, or planning to become pregnant within 30 days of last dose of XmAb7195.
Subjects who have used prescription drugs within 28 days prior to randomization with the following exceptions for Part B subjects with atopic disease:
- Intranasal corticosteroids for allergic symptoms if the dose has been stable for 14 days prior to randomization.
- Inhaled short acting beta agonist (SABA) therapy for bronchospasm if dosing has been stable for 14 days prior to randomization.
- No other prescription drugs are allowed unless agreed as not clinically relevant by the Investigator and Sponsor.
- Subjects who have had an asthma exacerbation requiring hospitalization within the 1 year prior to randomization or having required oral corticosteroids within the 6 months prior to randomization.
- Subjects with poorly controlled asthma defined as SABA > 6 times/day on any day within the 4 weeks prior to randomization.
- Subjects who have used any of the following medications within the 3 months prior to randomization: oral or inhaled corticosteroids, long acting beta agonists (LABAs), leukotriene receptor antagonists (LTRAs), or any other asthma controller medication (occasional SABA use is allowed).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A1
XmAb7195 for IV infusion; dose level 1; 4 once-weekly doses
|
|
Experimental: Part A2
XmAb7195 for SC injection; dose level 1; 4 once weekly doses
|
|
Experimental: Part A3
XmAb7195 for SC injection; dose level 2; 4 once weekly doses
|
|
Experimental: Part A4
XmAb7195 for SC injection; dose level 3; 4 once weekly doses
|
|
Experimental: Part A5
XmAb7195 for SC injection; dose level 4; 4 once weekly doses
|
|
Experimental: Part B6
XmAb7195 or placebo for SC injection; dose level 5; 4 once-weekly doses
|
|
Experimental: Part B7
XmAb7195 or placebo for SC injection; dose level 6; 4 once-weekly doses
|
|
Experimental: Part B8
XmAb7195 or placebo for SC injection; dose level 7; 4 once-weekly doses
|
|
Experimental: Part B9
XmAb7195 or placebo for SC injection dose level 8; 4 once-weekly doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioavailability of SC XmAb7195 after 4 once-weekly doses as measured by the ratio of dose-normalized SC XmAb7195 area under the concentration-time curve (AUC) to dose-normalized IV XmAb7195 AUC.
Time Frame: Date of randomization up to Day 50
|
Date of randomization up to Day 50
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax, Maximum observed serum concentration
Time Frame: Date of randomization up to Day 50
|
Date of randomization up to Day 50
|
Time at which Cmax was observed [Tmax]
Time Frame: Date of randomization up to Day 50
|
Date of randomization up to Day 50
|
Area Under the Curve (AUC)
Time Frame: Date of randomization up to Day 50
|
Date of randomization up to Day 50
|
Terminal elimination half-life [t1/2]
Time Frame: Date of randomization up to Day 50
|
Date of randomization up to Day 50
|
Total body or systemic clearance [CL]
Time Frame: Date of randomization up to Day 50
|
Date of randomization up to Day 50
|
Apparent volume of distribution at steady state [Vss]
Time Frame: Date of randomization up to Day 50
|
Date of randomization up to Day 50
|
Immunogenicity of SC XmAb7195 and IV XmAb7195 as measured by incidence of development of anti-XmAb7195 antibody after 4 once-weekly doses
Time Frame: Date of randomization up to Day 50
|
Date of randomization up to Day 50
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Emanuel P DeNoia, MD, ICON Early Phase Services, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2016
Primary Completion (Actual)
February 24, 2017
Study Completion (Actual)
February 24, 2017
Study Registration Dates
First Submitted
August 24, 2016
First Submitted That Met QC Criteria
August 24, 2016
First Posted (Estimate)
August 29, 2016
Study Record Updates
Last Update Posted (Actual)
July 11, 2017
Last Update Submitted That Met QC Criteria
July 6, 2017
Last Verified
July 1, 2017
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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