NCT03047317

A Pharmacokinetic Study of MABp1 in Healthy Volunteers

A Phase I Pharmacokinetic Study of MABp1 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an open label study of MABp1 in six healthy volunteers. Participants will receive a single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 24 hr, 48 hr, 96 hr, 192 hr, and 336 hr). In addition to pharmacokinetic data, participants will be monitored for the development of treatment emergent adverse events.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	MABp1	Single dose of intravenous MABp1

Timeline

• Start date: 2017-02-15
• Primary completion: 2017-03-08
• Completion: 2017-03-31
• First posted: 2017-02-08
• Last updated: 2021-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study