A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease

Phase 1 Completed 54 enrolled Renibus Therapeutics, Inc.

Non-randomizedSequentialOpen-labelPrevention

Summary

This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with Stage 3/4 CKD.

Timeline

Start: 2019-08-27
Primary completion: 2020-04-22
Completion: 2020-12-31

Publications

Zager RA, Johnson ACM, Guillem A, Keyser J, Singh B. A Pharmacologic "Stress Test" for Assessing Select Antioxidant Defenses in Patients with CKD. Clin J Am Soc Nephrol. 2020 May 7;15(5):633-642. doi: 10.2215/CJN.15951219. Epub 2020 Apr 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RBT-1	Unknown	9 mg	Intravenous
Subject	RBT-1	Unknown	27 mg	Intravenous
Subject	RBT-1	Unknown	45 mg	Intravenous
Subject	RBT-1	Unknown	63 mg	Intravenous
Subject	RBT-1	Unknown	90 mg	Intravenous

A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease

Summary

Timeline

Publications

Drugs

Indications