- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03630029
RBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD
A Phase 1b Dose-escalating Study With RBT-1, in Healthy Volunteers and Subjects With Chronic Kidney Disease Stage 3b-4
Study Overview
Detailed Description
Study Type
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
- Body weight <125 kg.
- Able and willing to comply with all study procedures.
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.
- 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:
- History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.
- Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.
- Serum ferritin > 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.
- 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.
- Known hypersensitivity or previous anaphylaxis to RBT-1 or to components thereof. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Administer a dose 12mgFeS/9mg SnPP
12 healthy volunteers will be administered a single dose of 12 mg Iron Sucrose and 9 mg of Stannous Protoporphyrin and followed for seven days.
|
Escalating doses of drug will be compared for biomarker changes
Other Names:
|
Other: Administer a dose 60mgFeS/45 mg SnPP
12 healthy volunteers will be administered a single dose of 60 mg of Iron Sucrose and 45 mg of Stannous Protoporphyrin and followed for seven days.
|
Escalating doses of drug will be compared for biomarker changes
Other Names:
|
Other: Administer a dose 120mgFeS/90mg SnPP
12 healthy volunteers will be administered a single dose of 120 mg of Iron Sucrose and 90 mg of Stannous Protoporphyrin and followed for seven days.
|
Escalating doses of drug will be compared for biomarker changes
Other Names:
|
Other: Administer a dose 180mgFeS/135mg SnPP
12 healthy volunteers will be administered a single dose of 180 mg and 135 mg of Stannous Protoporphyrin and followed for seven days.
|
Escalating doses of drug will be compared for biomarker changes
Other Names:
|
Other: Administer a dose of FeS/SnPP CKD Arm
12 subjects with stage 3 or 4 CKD will be administered a single dose of Iron Sucrose and Stannous Protoporphyrin selected from the highest dose from the prior arm that evidences the best safety profile.
The subjects will be followed for seven days.
|
Escalating doses of drug will be compared for biomarker changes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of RBT-1 on biomarkers of cytoprotective activity
Time Frame: 7 days
|
Measuring Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1, the P21 biomarker systemic levels
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 7 days
|
Safety and tolerability of RBT-1 in Healthy Volunteers and subjects with CKD
|
7 days
|
Establish the optimal dose for future development
Time Frame: 60 days
|
The highest dose of RBT-1 with the best safety and tolerability will be determined
|
60 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REN-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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