A Study of RBT-9 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease

A Phase 1b Dose-escalating Study With RBT-9 in Healthy Volunteers and Volunteers With Chronic Kidney Disease Stage 3/4

This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-9 in healthy volunteers and in subjects with Stage 3/4 CKD.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Healthy Volunteers
• Intervention / Treatment: Drug: RBT-9

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Edgewater, Florida, United States, 32132
      • Riverside Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
2. Body weight <125 kg.
3. Able and willing to comply with all study procedures.

4. Female subjects must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until 28 days after study drug administration.

   Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until 28 days after study drug administration. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.

5. CKD stage 3 as determined by a GFR between 30-59 ml/min as estimated using the CKD-EPI equation.
6. CKD stage 4 as determined by a GFR between 15-29 ml/min as estimated using the CKD-EPI equation.

Exclusion Criteria:

1. History of malignancy, except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers. Cancer free for less than 5 years.
2. Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to Screening, whichever was longer.
3. Serum ferritin >500 ng/mL or received IV iron within 28 days of Screening.
4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
5. Any significant acute or chronic diseases, excluding CKD (≥ 15 ml/min); if CKD is present, those not at their baseline of renal function.
6. Abnormal Baseline liver tests or hepatitis serologies that suggest active infection.
7. Regular use of drugs of abuse and/or positive findings on urinary drug screening.
8. Current tobacco use and/or positive findings on urinary cotinine screening.
9. Severely physically or mentally incapacitated and who, in the opinion of Investigator, are unable to perform the subjects' tasks associated with the protocol.
10. Presence of any condition which, in the opinion of the Investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
11. History of photosensitivity or active skin disease which, in the opinion of the Investigator, could increase the risk of photosensitivity.
12. Known hypersensitivity or previous anaphylaxis to RBT-9 or tin-based product.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9 mg	Drug: RBT-9; intravenous administration
Experimental: 27 mg	Drug: RBT-9; intravenous administration
Experimental: 90 mg	Drug: RBT-9; intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of RBT-9 on Plasma Ferritin Levels	Percent Change in Plasma Ferritin From Baseline to 24 hours	24 hours post-infusion
Effect of RBT-9 on Plasma HO-1 Levels	Percent Change in Plasma HO-1 From Baseline to 24 hours	24 hours post-infusion
Effect of RBT-9 on Plasma IL-10 Levels	Percent Change in Plasma IL-10 From Baseline to 24 hours	24 hours post-infusion

Collaborators and Investigators

• Sponsor: Renibus Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2019
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: REN-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No