Phase 1
N=42
A Study of RBT-9 in Healthy Volunteers and Volunteers With Stage 3/4 Chronic Kidney Disease
Healthy Volunteers · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT04072861 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Effect of RBT-9 on Plasma Ferritin Levels — -9.83; 7.66; 39.37 Percent change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RBT-9 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Renibus Therapeutics, Inc.
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of RBT-9 on Plasma Ferritin Levels |
-9.83; 7.66; 39.37 | — |
| PRIMARY Effect of RBT-9 on Plasma HO-1 Levels |
-16.07; 10.46; 33.37 | — |
| PRIMARY Effect of RBT-9 on Plasma IL-10 Levels |
1.07; 153.11; 752.53 | — |
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
- Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
- Body weight 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.
Data sourced from ClinicalTrials.gov (NCT04072861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.