Healthy VolunteersPhase 1NCT02881853
Safety, Tolerability, and Bioavailability of Subcutaneously Administered XmAb®7195
A Phase 1 study testing XmAb7195 in people with Healthy Volunteers and Atopic Disease, run by Xencor, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Atopic Disease
- What is being tested?
- XmAb7195
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2016to 24 Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
About this study
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.
Read the 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.
- Conditions
- Healthy Volunteers, Atopic Disease
- Being tested
- XmAb7195, Placebo
- Keywords
- healthy, atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb7195Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A1 | Experimental | XmAb7195 for IV infusion; dose level 1; 4 once-weekly doses Receives: Drug: XmAb7195 |
| Part A2 | Experimental | XmAb7195 for SC injection; dose level 1; 4 once weekly doses Receives: Drug: XmAb7195 |
| Part A3 | Experimental | XmAb7195 for SC injection; dose level 2; 4 once weekly doses Receives: Drug: XmAb7195 |
| Part A4 | Experimental | XmAb7195 for SC injection; dose level 3; 4 once weekly doses Receives: Drug: XmAb7195 |
| Part A5 | Experimental | XmAb7195 for SC injection; dose level 4; 4 once weekly doses Receives: Drug: XmAb7195 |
| Part B6 | Experimental | XmAb7195 or placebo for SC injection; dose level 5; 4 once-weekly doses Receives: Drug: XmAb7195; Drug: Placebo |
| Part B7 | Experimental | XmAb7195 or placebo for SC injection; dose level 6; 4 once-weekly doses Receives: Drug: XmAb7195; Drug: Placebo |
| Part B8 | Experimental | XmAb7195 or placebo for SC injection; dose level 7; 4 once-weekly doses Receives: Drug: XmAb7195; Drug: Placebo |
| Part B9 | Experimental | XmAb7195 or placebo for SC injection dose level 8; 4 once-weekly doses Receives: Drug: XmAb7195; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Date of randomization up to Day 50
Secondary outcomes (7)
Cmax, Maximum observed serum concentration
Measured: Date of randomization up to Day 50
Time at which Cmax was observed [Tmax]
Measured: Date of randomization up to Day 50
Area Under the Curve (AUC)
Measured: Date of randomization up to Day 50
Terminal elimination half-life [t1/2]
Measured: Date of randomization up to Day 50
Total body or systemic clearance [CL]
Measured: Date of randomization up to Day 50
Apparent volume of distribution at steady state [Vss]
Measured: 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
Measured: Date of randomization up to Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start17 Aug 2016
- Primary completion24 Feb 2017
- Study completion24 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Emanuel P DeNoia, MD, Principal investigator, ICON plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881853
- Sponsor's protocol ID
- XmAb7195-02
- Status last verified
- Jul 2017
- First submitted
- 24 Aug 2016
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Bioavailability of Subcutaneously Administered XmAb®7195
- ClinicalTrials.gov ID
- NCT02881853
- Acronym / sponsor ID
- XmAb7195-02
- Conditions
- Healthy Volunteers, Atopic Disease
- Keywords
- healthy, atopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- 24 Feb 2017 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A1 | Experimental | Drug: XmAb7195XmAb7195 for IV infusion; dose level 1; 4 once-weekly doses |
| Part A2 | Experimental | Drug: XmAb7195XmAb7195 for SC injection; dose level 1; 4 once weekly doses |
| Part A3 | Experimental | Drug: XmAb7195XmAb7195 for SC injection; dose level 2; 4 once weekly doses |
| Part A4 | Experimental | Drug: XmAb7195XmAb7195 for SC injection; dose level 3; 4 once weekly doses |
| Part A5 | Experimental | Drug: XmAb7195XmAb7195 for SC injection; dose level 4; 4 once weekly doses |
| Part B6 | Experimental | Drug: XmAb7195, Drug: PlaceboXmAb7195 or placebo for SC injection; dose level 5; 4 once-weekly doses |
| Part B7 | Experimental | Drug: XmAb7195, Drug: PlaceboXmAb7195 or placebo for SC injection; dose level 6; 4 once-weekly doses |
| Part B8 | Experimental | Drug: XmAb7195, Drug: PlaceboXmAb7195 or placebo for SC injection; dose level 7; 4 once-weekly doses |
| Part B9 | Experimental | Drug: XmAb7195, Drug: PlaceboXmAb7195 or placebo for SC injection dose level 8; 4 once-weekly doses |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XmAb7195 | Drug | Part A1, Part A2, Part A3, Part A4, Part A5, Part B6, Part B7, Part B8, Part B9 |
| Placebo | Drug | Part B6, Part B7, Part B8, Part B9 |
Primary outcome
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
7 secondary outcomes
Cmax, Maximum observed serum concentration
Time frame: Date of randomization up to Day 50
Time at which Cmax was observed [Tmax]
Time frame: Date of randomization up to Day 50
Area Under the Curve (AUC)
Time frame: Date of randomization up to Day 50
Terminal elimination half-life [t1/2]
Time frame: Date of randomization up to Day 50
Total body or systemic clearance [CL]
Time frame: Date of randomization up to Day 50
Apparent volume of distribution at steady state [Vss]
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuel P DeNoia, MD principal investigator
ICON plc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XmAb7195 in people with Healthy Volunteers and Atopic Disease, run by Xencor, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.