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XmAb5871 Bioavailability Study

Sponsored by Xencor, Inc.

About this trial

Last updated 8 years ago

Study ID

XmAb5871-05

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18 to 55 Years
All Sexes

Trial Timing

Ended 10 years ago

What is this trial about?

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

What are the participation requirements?

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.