RBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD

NCT03630029 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: REN-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase 1b study to evaluate the safety, tolerability and pharmacodynamic effect of RBT-1 in healthy volunteers and subjects with stage 3b-4 CKD.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Effect of RBT-1 on biomarkers of cytoprotective activity

  Measuring Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1, the P21 biomarker systemic levels

  7 days

Secondary Outcomes (2)

• Adverse events

  7 days

• Establish the optimal dose for future development

  60 days

Study Arms (5)

Administer a dose 12mgFeS/9mg SnPP

OTHER

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.

Drug: FeS and SnPP

Administer a dose 60mgFeS/45 mg SnPP

OTHER

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.

Drug: FeS and SnPP

Administer a dose 120mgFeS/90mg SnPP

OTHER

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.

Drug: FeS and SnPP

Administer a dose 180mgFeS/135mg SnPP

OTHER

12 healthy volunteers will be administered a single dose of 180 mg and 135 mg of Stannous Protoporphyrin and followed for seven days.

Drug: FeS and SnPP

Administer a dose of FeS/SnPP CKD Arm

OTHER

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.

Drug: FeS and SnPP

Interventions

FeS and SnPP DRUG

Escalating doses of drug will be compared for biomarker changes

Also known as: FeS (Iron Sucrose) SnPP (Stannous Protoporpyhrin

Administer a dose 120mgFeS/90mg SnPP; Administer a dose 12mgFeS/9mg SnPP; Administer a dose 180mgFeS/135mg SnPP; Administer a dose 60mgFeS/45 mg SnPP; Administer a dose of FeS/SnPP CKD Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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). -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Renibus Therapeutics, Inc.: lead

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

proto-oncogene protein c-fes-fps; tin protoporphyrin IX; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 14, 2018
• Study Start: September 15, 2018
• Primary Completion: November 30, 2018
• Study Completion: March 31, 2019
• Last Updated: May 11, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share