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PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing OJR520 for Chronic Kidney Disease

The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.

Official registry: https://clinicaltrials.gov/study/NCT07235059 · Novartis Pharmaceuticals · enrollment listed as 112

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are OJR520, or Placebo. The registry lists allocation as randomized. The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.

They plan to enroll about 112 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: OJR520, Placebo

Primary outcome (registry wording): Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • 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
  • Male and female participants 18 to 65 years of age

Public study contact (from the registry)

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

+ 1 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07235059 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07235059?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07235059?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary