Overview

This trial is active, not recruiting.

Condition healthy volunteers
Treatment xmab5871
Phase phase 1
Sponsor Xencor, Inc.
Collaborator PAREXEL International Early Phase Clinical Unit
Start date July 2016
End date October 2016
Trial size 50 participants
Trial identifier NCT02867098, XmAb5871-05

Summary

An open label comparison of concentration of the study medication administered intravenously (IV) versus subcutaneously (SC) in healthy volunteers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Dose Level 1 XmAb5871 given SC Q14days X 3
xmab5871
(Experimental)
Dose Level 2 XmAb5871 given SC Q14days X 3
xmab5871
(Experimental)
Dose Level 3 XmAb5871 given SC Q14days X 3
xmab5871
(Experimental)
Dose Level 4 XmAb5871 given IV Q14days X 3
xmab5871
(Experimental)
Dose Level 5 XmAb5871 given SC Q7days X 3
xmab5871

Primary Outcomes

Measure
Cmax, Maximum observed serum concentration
time frame: Date of randomization to Day 57
Tmax, Time of maximum observed serum concentration
time frame: Date of randomization to Day 57
AUC, Area under the plasma concentration versus time curve
time frame: Date of randomization to Day 57
CL, Clearance of drug from the body
time frame: Date of randomization to Day 57
Vz, Volume of distribution
time frame: Date of randomization to Day 57
F, bioavailability of a SC dose relative to an IV dose
time frame: Date of randomization to Day 57
Number of participants with adverse events that are related to treatment
time frame: Date of randomization to Day 57
Number of participants with severe adverse events that are related to treatment
time frame: Date of randomization to Day 57
Number of participants with abnormal laboratory values related to treatment
time frame: Date of randomization to Day 57
Number of participants with abnormal ECGs related to treatment
time frame: Date of randomization to Day 57

Secondary Outcomes

Measure
Titers of anti-XmAb5871 antibody will be assessed from time of dosing up to Day 57
time frame: Date of randomization to Day 57
Percent of participants positive in the assay at at least one time point
time frame: Date of randomization to Day 57
Percent of participants with increasing titers of anti-drug antibody over time
time frame: Date of randomization to Day 57

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title Pharmacokinetics and Relative Bioavailability of XmAb®5871 Administered Either Intravenously or Subcutaneously
Principal investigator Esther Yoon, MD
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. Each subject will be randomized to 1 of the 5 dose cohorts. Randomization will be generated by population prior to study start. Subjects will receive 3 administrations of study medication.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Xencor, Inc..