XmAb5871 Bioavailability Study

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT02867098

Run by

Xencor, Inc.

People needed

50

Starts

2016-07-01

Expected to finish

2016-10-21

Last updated by the study team

2017-12-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.