XmAb5871 Bioavailability Study
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 12/10/2017 |
Start Date: | July 2016 |
End Date: | October 21, 2016 |
Pharmacokinetics and Relative Bioavailability of XmAb®5871 Administered Either Intravenously or Subcutaneously
An open label comparison of concentration of the study medication administered intravenously
(IV) versus subcutaneously (SC) in healthy volunteers.
(IV) versus subcutaneously (SC) in healthy volunteers.
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.
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.
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.
We found this trial at
1
site
1560 East Chevy Chase Drive
Glendale, California 91206
Glendale, California 91206
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