NCT03630029

RBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD

A Phase 1b Dose-escalating Study With RBT-1, in Healthy Volunteers and Subjects With Chronic Kidney Disease Stage 3b-4

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Renibus Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A Phase 1b study to evaluate the safety, tolerability and pharmacodynamic effect of RBT-1 in healthy volunteers and subjects with stage 3b-4 CKD.

Detailed description

This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with stage 3b-4 CKD. The following biomarkers will be used as surrogate measures of protective activity: Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1. Additionally, the P21 biomarker will be monitored at various points of the study.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	FeS and SnPP	Escalating doses of drug will be compared for biomarker changes

Timeline

• Start date: 2018-09-15
• Primary completion: 2018-11-30
• Completion: 2019-03-31
• First posted: 2018-08-14
• Last updated: 2020-05-11

Regulatory

• FDA-regulated drug study