Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Parexel | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open label comparison of concentration of the study medication administered intravenously (IV) versus subcutaneously (SC) in healthy volunteers.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose Level 1 XmAb5871 given SC Q14days X 3 |
|
| Cohort 2 | Experimental | Dose Level 2 XmAb5871 given SC Q14days X 3 |
|
| Cohort 3 | Experimental | Dose Level 3 XmAb5871 given SC Q14days X 3 |
|
| Cohort 4 | Experimental | Dose Level 4 XmAb5871 given IV Q14days X 3 |
|
| Cohort 5 | Experimental | Dose Level 5 XmAb5871 given SC Q7days X 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb5871 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, Maximum observed serum concentration | Date of enrollment to Day 57 | |
| Tmax, Time of maximum observed serum concentration | Date of enrollment to Day 57 | |
| AUC, Area under the plasma concentration versus time curve | Date of enrollment to Day 57 | |
| CL, Clearance of drug from the body | Date of enrollment to Day 57 | |
| Vz, Volume of distribution | Date of enrollment to Day 57 | |
| F, bioavailability of a SC dose relative to an IV dose | Date of enrollment to Day 57 | |
| Number of participants with adverse events that are related to treatment | Date of enrollment to Day 57 | |
| Number of participants with severe adverse events that are related to treatment | Date of enrollment to Day 57 | |
| Number of participants with abnormal laboratory values related to treatment | Date of enrollment to Day 57 | |
| Number of participants with abnormal ECGs related to treatment | Date of enrollment to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Titers of anti-XmAb5871 antibody will be assessed from time of dosing up to Day 57 | Date of enrollment to Day 57 | |
| Percent of participants positive in the assay at at least one time point | Date of enrollment to Day 57 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Esther Yoon, MD | California Clinical Trials Medical Group - PAREXEL, Early Phase Clinical Unit-Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL, Early Phase Clinical Unit-Los Angeles | Glendale | California | 91206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39636565 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percent of participants with increasing titers of anti-drug antibody over time | Date of enrollment to Day 57 |