XmAb5871 Bioavailability Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-10-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Volunteers

Keywords

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healthy volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

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XmAb5871

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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PAREXEL, Early Phase Clinical Unit-Los Angeles

Glendale, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 39636565 (View on PubMed)

Other Identifiers

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XmAb5871-05

Identifier Type: -

Identifier Source: org_study_id

XmAb5871 Bioavailability Study

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Cohort 1

XmAb5871

Cohort 2

XmAb5871

Cohort 3

XmAb5871

Cohort 4

XmAb5871

Cohort 5

XmAb5871

Interventions

XmAb5871

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Parexel

Xencor, Inc.

Responsible Party

Principal Investigators

Esther Yoon, MD

Locations

PAREXEL, Early Phase Clinical Unit-Los Angeles

Countries

References

Other Identifiers

XmAb5871-05