Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.

Summary

This is a phase I, randomized, single-blind, parallel group, placebo-controlled, multi-cohort, first-in-human dose escalation study of a single IV 3-hour administration of Cilastatin as stand-alone in healthy male and female volunteers. The study objectives are: The evaluation of safety and tolerability of single intravenous doses of cilastatin in healthy volunteers administered as a 3-hour infusion. The evaluation of the pharmacokinetic characteristics of Cilastatin after a single 3-hour infusion dose.

Timeline

Start

2018-06-19

Primary completion

2018-08-09

Completion

2018-08-09

Publications

• Faubel S. Acute Cardiac Injury Mediates a Distinct Form of CKD: Is This Cardiorenal Syndrome Type 7? J Am Soc Nephrol. 2025 Dec 1;36(12):2317-2319. doi: 10.1681/ASN.0000000905. Epub 2025 Oct 27. No abstract available.
• Funahashi Y, Hebert JF, Munhall A, Aomura D, Burfeind KG, Nguyen ED, Groat T, Nickerson MN, Eiwaz MB, Nelson JW, Andeen NK, Yanagita M, Gurley SB, Hutchens MP. Cardiac LIM Protein, Kidney Fibrosis, and Vascular Change after Acute Cardiorenal Syndrome. J Am Soc Nephrol. 2025 Dec 1;36(12):2330-2347. doi: 10.1681/ASN.0000000774. Epub 2025 Jun 19.

Drugs

Indications

No indication recorded.