NCT02881853

Safety, Tolerability, and Bioavailability of Subcutaneously Administered XmAb®7195

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1b, combined multiple dose subcutaneous (SC) bioavailability (BA) and multiple ascending dose (MAD) study evaluating safety, tolerability and BA of SC XmAb7195 in healthy subjects and in subjects with atopic disease.

Detailed description

The study will be divided into 2 parts. Part A will be an open-label, parallel group, BA study evaluating 4 once-weekly doses of IV XmAb7195 or SC XmAb7195 in healthy subjects. Each of 5 treatment groups will consist of 6 subjects. Part B will commence following the completion of Part A and will be a randomized, double-blind, placebo-controlled, MAD study evaluating 4 once weekly doses of SC XmAb7195 in healthy subjects and/or subjects with atopic disease. Each treatment group will consist of 8 subjects randomized 3:1 to XmAb7195:placebo Subjects in both parts of the study will be followed for at least 28 days after their last dose.

Conditions

• Healthy Volunteers
• Atopic Disease

Interventions

Type	Name	Description
DRUG	XmAb7195
DRUG	Placebo

Timeline

• Start date: 2016-08-17
• Primary completion: 2017-02-24
• Completion: 2017-02-24
• First posted: 2016-08-29
• Last updated: 2017-07-11

Locations

1 site across 1 country: United States