Healthy VolunteersPhase 1NCT02867098
XmAb5871 Bioavailability Study
A Phase 1 study testing XmAb5871 in people with Healthy Volunteers, run by Xencor, Inc. at 1 site in United States.
Trial summary
An open label comparison of concentration of the study medication administered intravenously (IV) versus subcutaneously (SC) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- XmAb5871
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 21 Oct 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are adult males and females aged 18 to 55 years inclusive as of dosing (Day 1) with total body weight between 45.0 and 100.0 kg inclusive and body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive;
- Healthy as assessed by the Investigator 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;
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 risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Subjects who are positive for drugs of abuse or alcohol on screening or admission;
- Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb5871.
- Subjects who have used prescription drugs (with the exception of hormonal birth control for women of child-bearing potential) within 14 days or 5 half-lives, whichever is longer, prior to dosing (Day 1), unless agreed as not clinically relevant by the Principal Investigator and Sponsor.
- Subjects who have received live vaccines ≤3 months from Day 1.
- Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin).
- Unable or unwilling to partake in follow-up assessments or required protocol procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
PAREXEL, Early Phase Clinical Unit-Los Angeles
Glendale, California, 91206
About this study
Official title: Pharmacokinetics and Relative Bioavailability of XmAb®5871 Administered Either Intravenously or Subcutaneously
An open label comparison of concentration of the study medication administered intravenously (IV) versus subcutaneously (SC) in healthy volunteers.
Read the detailed description
The study will enroll approximately 50 eligible healthy male and female subjects between the ages of 18 to 55 inclusive. There will be 5 parallel dose cohorts (Cohorts 1-5) consisting of 10 subjects in each cohort. No subject will be a member of more than 1 cohort. Subjects will receive 3 administrations of study medication.
- Conditions
- Healthy Volunteers
- Being tested
- XmAb5871
- Keywords
- healthy, volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb5871Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose Level 1 XmAb5871 given SC Q14days X 3 Receives: Drug: XmAb5871 |
| Cohort 2 | Experimental | Dose Level 2 XmAb5871 given SC Q14days X 3 Receives: Drug: XmAb5871 |
| Cohort 3 | Experimental | Dose Level 3 XmAb5871 given SC Q14days X 3 Receives: Drug: XmAb5871 |
| Cohort 4 | Experimental | Dose Level 4 XmAb5871 given IV Q14days X 3 Receives: Drug: XmAb5871 |
| Cohort 5 | Experimental | Dose Level 5 XmAb5871 given SC Q7days X 3 Receives: Drug: XmAb5871 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, Maximum observed serum concentration
Measured: Date of enrollment to Day 57
Tmax, Time of maximum observed serum concentration
Measured: Date of enrollment to Day 57
AUC, Area under the plasma concentration versus time curve
Measured: Date of enrollment to Day 57
CL, Clearance of drug from the body
Measured: Date of enrollment to Day 57
Vz, Volume of distribution
Measured: Date of enrollment to Day 57
F, bioavailability of a SC dose relative to an IV dose
Measured: Date of enrollment to Day 57
Number of participants with adverse events that are related to treatment
Measured: Date of enrollment to Day 57
Number of participants with severe adverse events that are related to treatment
Measured: Date of enrollment to Day 57
Number of participants with abnormal laboratory values related to treatment
Measured: Date of enrollment to Day 57
Number of participants with abnormal ECGs related to treatment
Measured: Date of enrollment to Day 57
Secondary outcomes (3)
Titers of anti-XmAb5871 antibody will be assessed from time of dosing up to Day 57
Measured: Date of enrollment to Day 57
Percent of participants positive in the assay at at least one time point
Measured: Date of enrollment to Day 57
Percent of participants with increasing titers of anti-drug antibody over time
Measured: Date of enrollment to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion21 Oct 2016
- Study completion21 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Esther Yoon, MD, Principal investigator, California Clinical Trials Medical Group - PAREXEL, Early Phase Clinical Unit-Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867098
- Sponsor's protocol ID
- XmAb5871-05
- Status last verified
- Dec 2017
- First submitted
- 2 Aug 2016
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wang X, Kirk R, Matijevic M, Gao M, Poma A, Quinn S, Arora S, Fischer T. Pharmacokinetics, Pharmacodynamics, Bioavailability, and Immunogenicity of Obexelimab Following Subcutaneous Administration in Healthy Japanese and Non-Japanese Volunteers. Adv Ther. 2025 Feb;42(2):813-829. doi: 10.1007/s12325-024-03067-6. Epub 2024 Dec 5.
PubMed 39636565
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Relative Bioavailability of XmAb®5871 Administered Either Intravenously or Subcutaneously
- ClinicalTrials.gov ID
- NCT02867098
- Acronym / sponsor ID
- XmAb5871-05
- Conditions
- Healthy Volunteers
- Keywords
- healthy, volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Jul 2016 (actual)
- Primary completion
- 21 Oct 2016 (actual)
- Study completion
- 21 Oct 2016 (actual)
- First posted
- 15 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.
An open label comparison of concentration of the study medication administered intravenously (IV) versus subcutaneously (SC) in healthy volunteers.
Detailed description
The study will enroll approximately 50 eligible healthy male and female subjects between the ages of 18 to 55 inclusive. There will be 5 parallel dose cohorts (Cohorts 1-5) consisting of 10 subjects in each cohort. No subject will be a member of more than 1 cohort. Subjects will receive 3 administrations of study medication.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: XmAb5871Dose Level 1 XmAb5871 given SC Q14days X 3 |
| Cohort 2 | Experimental | Drug: XmAb5871Dose Level 2 XmAb5871 given SC Q14days X 3 |
| Cohort 3 | Experimental | Drug: XmAb5871Dose Level 3 XmAb5871 given SC Q14days X 3 |
| Cohort 4 | Experimental | Drug: XmAb5871Dose Level 4 XmAb5871 given IV Q14days X 3 |
| Cohort 5 | Experimental | Drug: XmAb5871Dose Level 5 XmAb5871 given SC Q7days X 3 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Are adult males and females aged 18 to 55 years inclusive as of dosing (Day 1) with total body weight between 45.0 and 100.0 kg inclusive and body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive;
- Healthy as assessed by the Investigator 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;
Key exclusion criteria (7 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 risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Subjects who are positive for drugs of abuse or alcohol on screening or admission;
- Subject is pregnant or breast feeding, or planning to become pregnant within 3 months of administration of XmAb5871.
- Subjects who have used prescription drugs (with the exception of hormonal birth control for women of child-bearing potential) within 14 days or 5 half-lives, whichever is longer, prior to dosing (Day 1), unless agreed as not clinically relevant by the Principal Investigator and Sponsor.
- Subjects who have received live vaccines ≤3 months from Day 1.
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 |
|---|---|---|
| XmAb5871 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Cmax, Maximum observed serum concentration
Time frame: Date of enrollment to Day 57
Tmax, Time of maximum observed serum concentration
Time frame: Date of enrollment to Day 57
AUC, Area under the plasma concentration versus time curve
Time frame: Date of enrollment to Day 57
CL, Clearance of drug from the body
Time frame: Date of enrollment to Day 57
Vz, Volume of distribution
Time frame: Date of enrollment to Day 57
F, bioavailability of a SC dose relative to an IV dose
Time frame: Date of enrollment to Day 57
Number of participants with adverse events that are related to treatment
Time frame: Date of enrollment to Day 57
Number of participants with severe adverse events that are related to treatment
Time frame: Date of enrollment to Day 57
Number of participants with abnormal laboratory values related to treatment
Time frame: Date of enrollment to Day 57
Number of participants with abnormal ECGs related to treatment
Time frame: Date of enrollment to Day 57
3 secondary outcomes
Titers of anti-XmAb5871 antibody will be assessed from time of dosing up to Day 57
Time frame: Date of enrollment to Day 57
Percent of participants positive in the assay at at least one time point
Time frame: Date of enrollment to Day 57
Percent of participants with increasing titers of anti-drug antibody over time
Time frame: Date of enrollment to Day 57
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 8 Dec 2017.
- Derived from this study: PubMed 39636565Wang X, Kirk R, Matijevic M, Gao M, Poma A, Quinn S, Arora S, Fischer T. Pharmacokinetics, Pharmacodynamics, Bioavailability, and Immunogenicity of Obexelimab Following Subcutaneous Administration in Healthy Japanese and Non-Japanese Volunteers. Adv Ther. 2025 Feb;42(2):813-829. doi: 10.1007/s12325-024-03067-6. Epub 2024 Dec 5.
- Individual participant dataSharing planned: No
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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.
Esther Yoon, MD principal investigator
California Clinical Trials Medical Group - PAREXEL, Early Phase Clinical Unit-Los Angeles
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 XmAb5871 in people with Healthy Volunteers, 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 2 inclusion and 7 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 8 Dec 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?
Cmax, Maximum observed serum concentration (time frame: Date of enrollment to Day 57). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02867098, which also lists 1 linked publication.
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 8 Dec 2017.