NCT02127190

Study of CXA-10 in Healthy Volunteers

A Randomized, Double-Blind, Third Party Open (Sponsor), Dose-Rising, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of CXA-10 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Complexa, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This will be the first-in-human (FIH) study with CXA-10. The main purpose of this trial is to demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various incremental doses, and to demonstrate the safety and tolerability of the rate of the emulsion vehicle infusion in healthy volunteers. In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.

Conditions

• Acute Kidney Injury (Nontraumatic)

Interventions

Type	Name	Description
DRUG	CXA-10 emulsion	CXA-10 Injectable Emulsion is a sterile emulsion containing CXA-10 in a formulation containing soybean oil, medium chain triglycerides oil, egg phospholipids, sucrose, and disodium EDTA. CXA-10 Injectable Emulsion will be administered intravenously. The active emulsion will be diluted in a vehicle emulsion.
DRUG	Placebo

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2014-04-30
• Last updated: 2018-02-01

Locations

1 site across 1 country: United States