NCT02486770

Study of Single Doses of IV Aerucin in Healthy Adults

A Phase 1 Single-center (U.S.), Open Label, Dose-escalation Study of the Safety and Pharmacokinetics of Single Doses of Intravenous AerucinTM in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Aridis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety profile and pharmacokinetic behavior of a single administration of Aerucin in healthy adults at three different dosages.

Detailed description

This Phase I trial will be conducted as an open label trial in 15 healthy adults. All subjects will receive a specific intravenous dose of Aerucin. There are three study groups, each with a specific dose of Aerucin. Study Group 1 will receive 2.0 mg/ kg of Aerucin . Study Group 2 will receive 8.0 mg/kg of Aerucin . Study Group 3 will receive 20 mg/kg of Aerucin . The dose levels of Aerucin are selected for this study based on animal studies showing protection in an animal model and absence of adverse effects in toxicological studies. Groups will be enrolled sequentially.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Aerucin 2.0mg/kg	IV Aerucin 2.0 mg/kg over 1 hour
BIOLOGICAL	Aerucin 8.0mg/kg	IV Aerucin 8.0 mg/kg over 1 hour
BIOLOGICAL	Aerucin 20.0 mg/kg	IV Aerucin 20 mg/kg over 1 hour

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-07-01
• Last updated: 2015-12-30

Locations

1 site across 1 country: United States