CompletedPhase 1

A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease

United States54 participantsStarted 2019-08-27

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
✓. CKD Stage 3 as determined by estimated glomerular filtration rate (eGFR) between 30-59 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
✓. CKD Stage 4 as determined by eGFR between 15-29 mL/min/1.73 m2 using the CKD-EPI equation.

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.

What they're measuring

Effect of RBT-1 on Plasma Ferritin Levels

Timeframe: 24 hours post-infusion

Effect of RBT-1 on Plasma HO-1 Levels

Timeframe: 24 hours post-infusion

Effect of RBT-1 on Plasma IL-10 Levels

Timeframe: 24 hours post-infusion

Trial details

NCT IDNCT03893799

SponsorRenibus Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-22

Results submitted2023-12-22

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
✓. CKD Stage 3 as determined by estimated glomerular filtration rate (eGFR) between 30-59 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
✓. CKD Stage 4 as determined by eGFR between 15-29 mL/min/1.73 m2 using the CKD-EPI equation.

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.