Phase 1
N=54
A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease
Healthy Volunteers · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT03893799 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Effect of RBT-1 on Plasma Ferritin Levels — 592.3; 538.8; 313.7; 308.2 Percent change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RBT-1 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Renibus Therapeutics, Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of RBT-1 on Plasma Ferritin Levels |
592.3; 538.8; 313.7; 308.2; 610.9 | — |
| PRIMARY Effect of RBT-1 on Plasma HO-1 Levels |
-10.5; 21; 35.4; 27.7; 44.8 | — |
| PRIMARY Effect of RBT-1 on Plasma IL-10 Levels |
66.8; 95.5; 574.6; 333.5; 201.4 | — |
Summary
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-1 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 who have received IV iron within 28 days of screening, or currently being treated with oral iron.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Any significant acute or chronic diseases.
- Subjects with 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.
- 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.
- 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.
- Subjects with history of photosensitivity or active skin disease
- Known hypersensitivity or previous anaphylaxis to RBT-1 or to components thereof.
Data sourced from ClinicalTrials.gov (NCT03893799). 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.