XmAb5871 Bioavailability Study

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867098
• Other study ID #: XmAb5871-05
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2016
• Last updated: December 6, 2017
• Start date: July 2016
• Est. completion date: October 21, 2016

Study information

• Verified date: December 2017
• Source: Xencor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 21, 2016
• Est. primary completion date: October 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• XmAb5871

Locations

Country	Name	City	State
United States	PAREXEL, Early Phase Clinical Unit-Los Angeles	Glendale	California

Sponsors (2)

Lead Sponsor	Collaborator
Xencor, Inc.	Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax, Maximum observed serum concentration		Date of enrollment to Day 57
Primary	Tmax, Time of maximum observed serum concentration		Date of enrollment to Day 57
Primary	AUC, Area under the plasma concentration versus time curve		Date of enrollment to Day 57
Primary	CL, Clearance of drug from the body		Date of enrollment to Day 57
Primary	Vz, Volume of distribution		Date of enrollment to Day 57
Primary	F, bioavailability of a SC dose relative to an IV dose		Date of enrollment to Day 57
Primary	Number of participants with adverse events that are related to treatment		Date of enrollment to Day 57
Primary	Number of participants with severe adverse events that are related to treatment		Date of enrollment to Day 57
Primary	Number of participants with abnormal laboratory values related to treatment		Date of enrollment to Day 57
Primary	Number of participants with abnormal ECGs related to treatment		Date of enrollment to Day 57
Secondary	Titers of anti-XmAb5871 antibody will be assessed from time of dosing up to Day 57		Date of enrollment to Day 57
Secondary	Percent of participants positive in the assay at at least one time point		Date of enrollment to Day 57
Secondary	Percent of participants with increasing titers of anti-drug antibody over time		Date of enrollment to Day 57