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Study of CXA-10 in Healthy Volunteers

NCT02127190 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-02-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Complexa, Inc.

    lead INDUSTRY

Principal Investigators

  • James VanderLugt, MD · Jasper Clinic, Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127190 on ClinicalTrials.gov