Overview

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

Status:
Active, not recruiting
Trial end date:
2020-12-31
Target enrollment:
0
Participant gender:
All
Summary
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 3-4 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Renibus Therapeutics, Inc.
Renibus Therapuetics, Inc.
Treatments:
Ferric Oxide, Saccharated
Iron
Protoporphyrin IX
Tin protoporphyrin IX
Criteria
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 as determined by estimated glomerular filtration rate (GFR) between 15-45 ml/min
as estimated using the CKD-EPI equation (CKD class 3b-4). -

Exclusion Criteria:

1. History of malignancy except carcinoma in situ in the cervix, early stage prostate
cancer or non-melanoma skin cancers.

2. Use of investigational drugs or participation in another clinical trial within 30 days
or 5 half-lives prior to screening, whichever is longer.

3. Serum ferritin > 500 ng/ml or who have received IV iron within 28 days of screening,
or currently being treated with oral iron.

4. Women who are pregnant, breastfeeding, or planning to become pregnant while
participating in the study.

5. Any significant acute or chronic diseases.

6. Subjects with 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. Subjects who are 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. Subjects with history of photosensitivity or active skin disease

12. Known hypersensitivity or previous anaphylaxis to RBT-1 or to components thereof. -