A Participant- and Investigator--Blinded, Placebo- Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
Novartis Pharmaceuticals
Summary
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
Description
This is a three-part randomized, participant- and investigator blinded, placebo-controlled, multi-center, sequential study: single ascending dose (SAD) in healthy volunteers (HV), SAD in participants with chronic kidney disease (CKD) or diabetic chronic kidney disease (DKD) and multiple ascending dose (MAD) in participants with CKD or DKD.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Able to provide written informed consent before any assessment is performed. Part A (HV): • Healthy male and female participants in good health as determined by past medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests at screening and baseline within the normal range. Parts B \& C (CKD) • Male and female participants 18 to 65 years of age. Exclusion Criteria: * Women of childbearing potential. * Sexually active males unwilling to use contraception. Part A (HV): * Clinically significant abnormal blood pressure, defined as SBP \<90 m…
Interventions
- DrugOJR520
Participants will receive OJR520 in different dose levels.
- OtherPlacebo
Participants will receive OJR520 matching placebo.
Locations (2)
- Quotient Sciences Sea ViewMiami, Florida
- Novartis Investigative SiteBerlin