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

NCT04072861 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: REN-003
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

9 mg

EXPERIMENTAL

Drug: RBT-9

27 mg

EXPERIMENTAL

Drug: RBT-9

90 mg

EXPERIMENTAL

Drug: RBT-9

Interventions

RBT-9 DRUG

intravenous administration

27 mg; 9 mg; 90 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
• Body weight \<125 kg.
• Able and willing to comply with all study procedures.
• 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.
• CKD stage 3 as determined by a GFR between 30-59 ml/min as estimated using the CKD-EPI equation.
• CKD stage 4 as determined by a GFR between 15-29 ml/min as estimated using the CKD-EPI equation.

You may not qualify if:

• 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.
• Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to Screening, whichever was longer.
• Serum ferritin \>500 ng/mL or received IV iron within 28 days of Screening.
• Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
• Any significant acute or chronic diseases, excluding CKD (≥ 15 ml/min); if CKD is present, those not at their baseline of renal function.
• Abnormal Baseline liver tests or hepatitis serologies that suggest active infection.
• Regular use of drugs of abuse and/or positive findings on urinary drug screening.
• Current tobacco use and/or positive findings on urinary cotinine screening.
• Severely physically or mentally incapacitated and who, in the opinion of Investigator, are unable to perform the subjects' tasks associated with the protocol.
• 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.
• History of photosensitivity or active skin disease which, in the opinion of the Investigator, could increase the risk of photosensitivity.
• Known hypersensitivity or previous anaphylaxis to RBT-9 or tin-based product.

Sponsors & Collaborators

• Renibus Therapeutics, Inc.: lead

Study Sites (1)

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

tin protoporphyrin IX

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Donald J Keyser, Chief Operating Officer
• Organization: Renibus Therapeutics

jkeyser@renibus.com

18178756991

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: March 31, 2019
• Primary Completion: July 31, 2020
• Study Completion: October 31, 2020
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)