drugset / Trial / NCT03047317

A Pharmacokinetic Study of MABp1 in Healthy Volunteers

NCT03047317

Phase 1 Completed 6 enrolled Janssen Research & Development, LLC
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-02-15
Primary completion
2017-03-08
Completion
2017-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bermekimab Monoclonal antibody 7.5 mg/kg Intravenous

Indications

No indication recorded.