Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
NCT07235059 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2026-05-05
Summary
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
Conditions
Interventions
- DRUG
-
OJR520
Participants will receive OJR520 in different dose levels.
- OTHER
-
Placebo
Participants will receive OJR520 matching placebo.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-20
- Primary Completion
- 2028-01-21
- Completion
- 2028-01-21
- FDA Drug
- Yes
Countries
- United States
- Germany
Study Locations
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