Clinical trial NCT04072861: A Study of RBT-9 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease
Official title: A Phase 1b Dose-escalating Study With RBT-9 in Healthy Volunteers and Volunteers With Chronic Kidney Disease Stage 3/4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Chronic Kidney Disease
Lead sponsor: Renibus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


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 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.

Primary outcomes:
measure: Effect of RBT-9 on Plasma Ferritin Levels
timeFrame: 24 hours post-infusion
measure: Effect of RBT-9 on Plasma HO-1 Levels
timeFrame: 24 hours post-infusion
measure: Effect of RBT-9 on Plasma IL-10 Levels
timeFrame: 24 hours post-infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
Study officials:
References: