A Study With Iron Sucrose in Healthy Volunteers and Chronic Kidney Disease Stage 3-4 Subjects

• Status: Completed
• Trial end date: 2019-08-26
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1b dose-escalating study evaluating the pharmacodynamic effect of FeS in healthy volunteers and chronic kidney disease stage 3-4 subjects. Biomarkers will be used as surrogate measures of protective activity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Renibus Therapeutics, Inc.; Renibus Therapuetics, Inc.
• Treatments: Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

Healthy Volunteers

1. Male and female subjects age 18 to 80 years (inclusive, at time of ICF).

2. Body weight <125 kg.

3. Able and willing to comply with all study procedures.

4. 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 Subjects

1. Male and female subjects age 18 to 80 years (inclusive, at time of ICF).

2. Body weight <125 kg.

3. Able and willing to comply with all study procedures.

4. 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.

5. CKD as determined by estimated glomerular filtration rate (GFR) between 15-59 ml/min as estimated using the CKD-EPI equation (CKD class 3-4).

Exclusion Criteria:

Healthy Volunteers

1. History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.

2. Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.

3. Serum ferritin > 500 ng/ml or who have received IV iron within 28 days of screening.

4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.

5. Any significant acute or chronic diseases.

6. Regular use of drugs of abuse and/or positive findings on urinary drug screening.

7. Current tobacco use and/or positive findings on urinary cotinine screening.

8. 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.

9. 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.

10. Known hypersensitivity or previous anaphylaxis to FeS.

CKD Subjects

1. History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.

2. Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.

3. Serum ferritin > 500 ng/ml or who have received IV iron within 28 days of screening, or currently being treated with oral iron.

4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.

5. Regular use of drugs of abuse and/or positive findings on urinary drug screening.

6. Current tobacco use and/or positive findings on urinary cotinine screening.

7. 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.

8. 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.

9. Known hypersensitivity or previous anaphylaxis to FeS or to components thereof.