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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 120 mg | Experimental |
| |
| 240 mg | Experimental |
| |
| 360 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBT-3 | Drug | intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of RBT-3 on Plasma Ferritin Levels | 24 hours post-infusion | |
| Effect of RBT-3 on Plasma HO-1 Levels | 24 hours post-infusion |
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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 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.
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 120 mg | Single IV infusion |
| FG001 | 240 mg | Single IV infusion |
| FG002 | 360 mg | Single IV infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 120 mg | Single IV infusion |
| BG001 | 240 mg | Single IV infusion |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of RBT-3 on Plasma Ferritin Levels | Posted | Least Squares Mean | 95% Confidence Interval | Ratio (24 h post-infusion over baseline) | 24 hours post-infusion |
|
8 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 120 mg | Single IV infusion | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacey Ruiz, PhD / VP, Drug Development | Renibus Therapeutics | 424-209-2734 | sruiz@renibus.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 5, 2018 | Dec 1, 2021 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2019 | Dec 1, 2021 | SAP_005.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 360 mg |
Single IV infusion |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Effect of RBT-3 on Plasma HO-1 Levels | Posted | Least Squares Mean | 95% Confidence Interval | Ratio (24 h post-infusion over baseline) | 24 hours post-infusion |
|
|
|
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 240 mg | Single IV infusion | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 360 mg | Single IV infusion | 0 | 6 | 0 | 6 | 1 | 6 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |