Clinical trial NCT02867098: XmAb5871 Bioavailability Study
Official title: Pharmacokinetics and Relative Bioavailability of XmAb®5871 Administered Either Intravenously or Subcutaneously
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: healthy
volunteer
Lead sponsor: Xencor, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2016-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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;

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 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.

Primary outcomes:
measure: Cmax, Maximum observed serum concentration
timeFrame: Date of enrollment to Day 57
measure: Tmax, Time of maximum observed serum concentration
timeFrame: Date of enrollment to Day 57
measure: AUC, Area under the plasma concentration versus time curve
timeFrame: Date of enrollment to Day 57
measure: CL, Clearance of drug from the body
timeFrame: Date of enrollment to Day 57
measure: Vz, Volume of distribution
timeFrame: Date of enrollment to Day 57
measure: F, bioavailability of a SC dose relative to an IV dose
timeFrame: Date of enrollment to Day 57
measure: Number of participants with adverse events that are related to treatment
timeFrame: Date of enrollment to Day 57
measure: Number of participants with severe adverse events that are related to treatment
timeFrame: Date of enrollment to Day 57
measure: Number of participants with abnormal laboratory values related to treatment
timeFrame: Date of enrollment to Day 57
measure: Number of participants with abnormal ECGs related to treatment
timeFrame: Date of enrollment to Day 57
Secondary outcomes:
measure: Titers of anti-XmAb5871 antibody will be assessed from time of dosing up to Day 57
timeFrame: Date of enrollment to Day 57
measure: Percent of participants positive in the assay at at least one time point
timeFrame: Date of enrollment to Day 57
measure: Percent of participants with increasing titers of anti-drug antibody over time
timeFrame: Date of enrollment to Day 57
Other outcomes:
Locations:
city: Glendale
country: United States
facility: PAREXEL, Early Phase Clinical Unit-Los Angeles
state: California
Study officials:
affiliation: California Clinical Trials Medical Group - PAREXEL, Early Phase Clinical Unit-Los Angeles
name: Esther Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References: