A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease
NCT03893799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2025-08-07
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.
Conditions
- Healthy Volunteers
- Chronic Kidney Disease
Interventions
- DRUG
-
RBT-1
Single intravenous administration
Sponsors & Collaborators
-
Renibus Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-08-27
- Primary Completion
- 2020-04-22
- Completion
- 2020-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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