NCT02148744

Safety and Tolerability of XmAb®7195 in Adult Healthy Volunteers and Adult Subjects With a History of Allergic Rhinitis and/or Allergic Conjunctivitis and/or Atopic Dermatitis

A Randomized, Double-Blinded, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®7195

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This first-in-human (FIH) study is a randomized, double-blinded, placebo-controlled, ascending dose study to investigate the safety, tolerability, and pharmacokinetics of XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.

Conditions

• Allergic Rhinitis
• Allergic Conjunctivitis
• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	XmAb7195	Part 1 and 2: Single IV infusion of XmAb7195 or placebo Part 3: Two-dose sequential IV infusion of XmAb7195 or placebo on Day 1 and Day 8
BIOLOGICAL	Placebo

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-09-21
• Completion: 2015-09-21
• First posted: 2014-05-28
• Last updated: 2017-01-24

Locations

1 site across 1 country: United States