XmAb5871 Bioavailability Study

NCT02867098 | Completed Phase 1

• 1 other identifier: XmAb5871-05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

healthy; volunteer

Outcome Measures

Primary Outcomes (10)

• Cmax, Maximum observed serum concentration

  Date of enrollment to Day 57

• Tmax, Time of maximum observed serum concentration

  Date of enrollment to Day 57

• AUC, Area under the plasma concentration versus time curve

  Date of enrollment to Day 57

• CL, Clearance of drug from the body

  Date of enrollment to Day 57

• Vz, Volume of distribution

  Date of enrollment to Day 57

• F, bioavailability of a SC dose relative to an IV dose

  Date of enrollment to Day 57

• Number of participants with adverse events that are related to treatment

  Date of enrollment to Day 57

• Number of participants with severe adverse events that are related to treatment

  Date of enrollment to Day 57

• Number of participants with abnormal laboratory values related to treatment

  Date of enrollment to Day 57

• Number of participants with abnormal ECGs related to treatment

  Date of enrollment to Day 57

Secondary Outcomes (3)

• Titers of anti-XmAb5871 antibody will be assessed from time of dosing up to Day 57

  Date of enrollment to Day 57

• Percent of participants positive in the assay at at least one time point

  Date of enrollment to Day 57

• Percent of participants with increasing titers of anti-drug antibody over time

  Date of enrollment to Day 57

Study Arms (5)

Cohort 1

EXPERIMENTAL

Dose Level 1 XmAb5871 given SC Q14days X 3

Drug: XmAb5871

Cohort 2

EXPERIMENTAL

Dose Level 2 XmAb5871 given SC Q14days X 3

Drug: XmAb5871

Cohort 3

EXPERIMENTAL

Dose Level 3 XmAb5871 given SC Q14days X 3

Drug: XmAb5871

Cohort 4

EXPERIMENTAL

Dose Level 4 XmAb5871 given IV Q14days X 3

Drug: XmAb5871

Cohort 5

EXPERIMENTAL

Dose Level 5 XmAb5871 given SC Q7days X 3

Drug: XmAb5871

Interventions

XmAb5871 DRUG

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Xencor, Inc.: lead
• Parexel: collaborator

Study Sites (1)

PAREXEL, Early Phase Clinical Unit-Los Angeles

Glendale, California, 91206, United States

Location

Related Publications (1)

• Wang X, Kirk R, Matijevic M, Gao M, Poma A, Quinn S, Arora S, Fischer T. Pharmacokinetics, Pharmacodynamics, Bioavailability, and Immunogenicity of Obexelimab Following Subcutaneous Administration in Healthy Japanese and Non-Japanese Volunteers. Adv Ther. 2025 Feb;42(2):813-829. doi: 10.1007/s12325-024-03067-6. Epub 2024 Dec 5.

  PMID: 39636565 DERIVED

Study Officials

• Esther Yoon, MD

  California Clinical Trials Medical Group - PAREXEL, Early Phase Clinical Unit-Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 15, 2016
• Study Start: July 1, 2016
• Primary Completion: October 21, 2016
• Study Completion: October 21, 2016
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)