XmAb5871 Bioavailability Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: XmAb5871

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • PAREXEL, Early Phase Clinical Unit-Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Dose Level 1 XmAb5871 given SC Q14days X 3	Drug: XmAb5871
Experimental: Cohort 2; Dose Level 2 XmAb5871 given SC Q14days X 3	Drug: XmAb5871
Experimental: Cohort 3; Dose Level 3 XmAb5871 given SC Q14days X 3	Drug: XmAb5871
Experimental: Cohort 4; Dose Level 4 XmAb5871 given IV Q14days X 3	Drug: XmAb5871
Experimental: Cohort 5; Dose Level 5 XmAb5871 given SC Q7days X 3	Drug: XmAb5871

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Percent of participants with increasing titers of anti-drug antibody over time	Date of enrollment to Day 57

Collaborators and Investigators

• Sponsor: Xencor, Inc.
• Collaborators: Parexel
• Investigators: Principal Investigator: Esther Yoon, MD, California Clinical Trials Medical Group - PAREXEL, Early Phase Clinical Unit-Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 21, 2016
• Study Completion (Actual): October 21, 2016

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: healthy; volunteer
• Other Study ID Numbers: XmAb5871-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No