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XmAb5871 Bioavailability Study

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ClinicalTrials.gov Identifier: NCT02867098
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Xencor, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: XmAb5871 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics and Relative Bioavailability of XmAb®5871 Administered Either Intravenously or Subcutaneously
Actual Study Start Date : July 2016
Actual Primary Completion Date : October 21, 2016
Actual Study Completion Date : October 21, 2016

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



Primary Outcome Measures :
  1. Cmax, Maximum observed serum concentration [ Time Frame: Date of enrollment to Day 57 ]
  2. Tmax, Time of maximum observed serum concentration [ Time Frame: Date of enrollment to Day 57 ]
  3. AUC, Area under the plasma concentration versus time curve [ Time Frame: Date of enrollment to Day 57 ]
  4. CL, Clearance of drug from the body [ Time Frame: Date of enrollment to Day 57 ]
  5. Vz, Volume of distribution [ Time Frame: Date of enrollment to Day 57 ]
  6. F, bioavailability of a SC dose relative to an IV dose [ Time Frame: Date of enrollment to Day 57 ]
  7. Number of participants with adverse events that are related to treatment [ Time Frame: Date of enrollment to Day 57 ]
  8. Number of participants with severe adverse events that are related to treatment [ Time Frame: Date of enrollment to Day 57 ]
  9. Number of participants with abnormal laboratory values related to treatment [ Time Frame: Date of enrollment to Day 57 ]
  10. Number of participants with abnormal ECGs related to treatment [ Time Frame: Date of enrollment to Day 57 ]

Secondary Outcome Measures :
  1. Titers of anti-XmAb5871 antibody will be assessed from time of dosing up to Day 57 [ Time Frame: Date of enrollment to Day 57 ]
  2. Percent of participants positive in the assay at at least one time point [ Time Frame: Date of enrollment to Day 57 ]
  3. Percent of participants with increasing titers of anti-drug antibody over time [ Time Frame: Date of enrollment to Day 57 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867098


Locations
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United States, California
PAREXEL, Early Phase Clinical Unit-Los Angeles
Glendale, California, United States, 91206
Sponsors and Collaborators
Xencor, Inc.
Parexel
Investigators
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Principal Investigator: Esther Yoon, MD California Clinical Trials Medical Group - PAREXEL, Early Phase Clinical Unit-Los Angeles

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Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT02867098     History of Changes
Other Study ID Numbers: XmAb5871-05
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xencor, Inc.:
healthy
volunteer