A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3-4 Chronic Kidney Disease
Condition: Kidney Failure, Acute
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Acute Kidney Injury
Intervention: RBT-3
Intervention description: intravenous administration
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1b, single center, dose-escalating study evaluating the safety, tolerability,
      and pharmacodynamic effect of RBT-3 in healthy volunteers and in subjects with stage 3-4
      chronic kidney disease.
    

Eligibility 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 8 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 8 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 (eGFR) between 15-59 ml/min
             as estimated using the CKD-EPI equation (CKD class 3-4).

        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.

          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 (eGFR ≥15 ml/min).

          6. Regular use of drugs of abuse and/or positive findings on urinary drug screening.

          7. Current tobacco use and/or positive findings on urinary cotinine screening.

          8. 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.

          9. 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.

         10. Known hypersensitivity or previous anaphylaxis to FeS.