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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RBT-9
Sponsored by
Renibus Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Riverside Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2, Healthy Volunteers

Cohort 3, Healthy Volunteers

Cohort 4, Subjects with CKD Stage 3

Cohort 5, Subjects with CKD Stage 3

Cohort 6, Subjects with CKD Stage 4

Cohort 7, Subjects with CKD Stage 4

Arm Description

9 mg RBT-9, single dose

27 mg RBT-9, single dose

90 mg RBT-9, single dose

27 mg RBT-9, single dose

90 mg RBT-9, single dose

27 mg RBT-9, single dose

90 mg RBT-9, single dose

Outcomes

Primary Outcome Measures

Safety and tolerability of RBT-9
Incidence of adverse events

Secondary Outcome Measures

Full Information

First Posted
August 26, 2019
Last Updated
December 19, 2021
Sponsor
Renibus Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04072861
Brief Title
A Study of RBT-9 in Healthy Volunteers and Subjects With Stage 3-4 Chronic Kidney Disease
Official Title
A Phase 1b Dose-escalating Study With RBT-9 in Healthy Volunteers and Subjects With Chronic Kidney Disease Stage 3-4
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renibus Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
9 mg RBT-9, single dose
Arm Title
Cohort 2, Healthy Volunteers
Arm Type
Experimental
Arm Description
27 mg RBT-9, single dose
Arm Title
Cohort 3, Healthy Volunteers
Arm Type
Experimental
Arm Description
90 mg RBT-9, single dose
Arm Title
Cohort 4, Subjects with CKD Stage 3
Arm Type
Experimental
Arm Description
27 mg RBT-9, single dose
Arm Title
Cohort 5, Subjects with CKD Stage 3
Arm Type
Experimental
Arm Description
90 mg RBT-9, single dose
Arm Title
Cohort 6, Subjects with CKD Stage 4
Arm Type
Experimental
Arm Description
27 mg RBT-9, single dose
Arm Title
Cohort 7, Subjects with CKD Stage 4
Arm Type
Experimental
Arm Description
90 mg RBT-9, single dose
Intervention Type
Drug
Intervention Name(s)
RBT-9
Intervention Description
intravenous administration
Primary Outcome Measure Information:
Title
Safety and tolerability of RBT-9
Description
Incidence of adverse events
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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