NCT02127190

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

Completed Phase 1 Last updated 30 January 2018

What this trial tests

Phase 1 trial testing CXA-10 emulsion in Acute Kidney Injury (Nontraumatic) in 30 participants. Completed in 1 December 2014.

Timeline

1 April 2014

Primary endpoint
1 September 2014

1 December 2014

Quick facts

Lead sponsor	Complexa, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	1 April 2014
Primary completion	1 September 2014
Estimated completion	1 December 2014
Sites	1 location across United States

Drugs / interventions tested

• CXA-10 emulsion — full drug profile →
• Placebo

Conditions studied

• Acute Kidney Injury (Nontraumatic) — all drugs for Acute Kidney Injury (Nontraumatic) →

Sponsor

Complexa, Inc. — full company profile →

Who can join

Adults 18 to 50, any sex, with Acute Kidney Injury (Nontraumatic). Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of subjects with Serious and Non-Serious Adverse Events
  Time frame: First day of dosing through 30 days after the last dose

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting oxidative stress in disease: promise and limitations of antioxidant therapy.
   Forman HJ, Zhang H. · · 2021 · cited 1789× · PMID 34194012 · DOI 10.1038/s41573-021-00233-1
2. Nitrite and nitrate-dependent generation of anti-inflammatory fatty acid nitroalkenes.
   Delmastro-Greenwood M, Hughan KS, Vitturi DA, Salvatore SR, et al · · 2015 · cited 76× · PMID 26385079 · DOI 10.1016/j.freeradbiomed.2015.07.149
3. Nitro-fatty acids protect against steatosis and fibrosis during development of nonalcoholic fatty liver disease in mice.
   Rom O, Xu G, Guo Y, Zhu Y, et al · · 2019 · cited 51× · PMID 30772307 · DOI 10.1016/j.ebiom.2019.02.019
4. Nitro-fatty acids in cardiovascular regulation and diseases: characteristics and molecular mechanisms.
   Villacorta L, Gao Z, Schopfer FJ, Freeman BA, et al · · 2016 · cited 42× · PMID 26709810 · DOI 10.2741/4425
5. Evaluation of 10-Nitro Oleic Acid Bio-Elimination in Rats and Humans.
   Salvatore SR, Vitturi DA, Fazzari M, Jorkasky DK, et al · · 2017 · cited 30× · PMID 28054588 · DOI 10.1038/srep39900
6. Protection of nitro-fatty acid against kidney diseases.
   Wang W, Li C, Yang T. · · 2016 · cited 20× · PMID 26719362 · DOI 10.1152/ajprenal.00321.2015
7. Inflammatory signaling and metabolic regulation by nitro-fatty acids.
   Rom O, Khoo NKH, Chen YE, Villacorta L. · · 2018 · cited 17× · PMID 29578057 · DOI 10.1016/j.niox.2018.03.017
8. Suppression of Vascular Macrophage Activation by Nitro-Oleic Acid and its Implication for Abdominal Aortic Aneurysm Therapy.
   Zhao Y, Chang Z, Zhao G, Lu H, et al · · 2021 · cited 12× · PMID 32671602 · DOI 10.1007/s10557-020-07031-8