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Completed

NCT Number: NCT02867098

XmAb5871 Bioavailability Study

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PAREXEL, Early Phase Clinical Unit-Los Angeles

Glendale, California, 91206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

XmAb5871

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Xencor, Inc.

Industry

Collaborators

  • Parexel

Registry information

Official study title

Pharmacokinetics and Relative Bioavailability of XmAb®5871 Administered Either Intravenously or Subcutaneously

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2016
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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