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Clinical trial Recruiting at 2 sites Phase 1 Interventional Ages 18 to 65

OJR520 safety and dose testing in healthy people and adults with chronic kidney disease

Official title: 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

Run by Novartis · NCT07235059 · Data updated 2026-11-12

This trial will test whether OJR520 is safe, well tolerated, and how the body processes it in healthy volunteers and adults with chronic kidney disease (including diabetic CKD).

More Chronic Kidney Disease trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment112 (estimated)
SponsorNovartis
Industry-sponsored
Locations2 sites (Miami, Florida and 1 other locations)
StatusRecruiting
StartedNovember 20, 2025
Main results expectedJanuary 21, 2028
Study endsJanuary 21, 2028
Registry record updatedNovember 10, 2026
Trial IDNCT07235059 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy adults for the healthy-volunteer arm and adults aged 18–65 with chronic kidney disease (including diabetic CKD) for the CKD arms who can attend site visits and meet contraception requirements (women of childbearing potential are excluded).

Probably not a fit

Patients with severe comorbidities (for example advanced heart failure NYHA III–IV, active cancer except non-melanoma skin cancer), clinically significant arrhythmias, abnormal screening vital signs, pregnant or breastfeeding women, or those outside the allowed age range are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, randomized, participant- and investigator-blinded, placebo-controlled, multi-center study is conducted in three sequential parts: single ascending dose (SAD) in healthy volunteers, SAD in participants with CKD or DKD, and multiple ascending dose (MAD) in participants with CKD or DKD. Participants will receive OJR520 or placebo and undergo intensive safety, pharmacokinetic (PK), and pharmacodynamic (PD) monitoring including labs, vital signs, and ECGs. The SAD parts will establish tolerability and single-dose PK across increasing doses, and the MAD part will evaluate repeat dosing in CKD participants. Safety and PK/PD results from this trial will inform dose selection for later-phase studies.

Why it matters

Potential benefit: If successful, the trial could establish safe dose ranges and dosing schedules that enable further development of OJR520 as a potential treatment for chronic kidney disease.

How similar studies have gone: Early-phase PK and safety trials are a standard first step and several investigational CKD agents have completed similar first-in-human studies showing tolerability, but OJR520 itself is novel and has not yet been tested in humans.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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 mmHg or \>140 mmHg or DBP \<55 mmHg or \>95 mmHg.
* Abnormal resting HR, defined as \<45 bpm or \>90 bpm.

Part B \& C (CKD)

* History of, or currently active, significant illness or medical disorders including, but not limited to, cancer (except for non-melanoma skin cancer), heart failure NYHA III-IV, heart rhythm abnormalities (e.g., atrial fibrillation, sick sinus syndrome, permanent pacemaker), CKD due to autoimmune disease, kidney transplant, dialysis or any other disease the investigator believes may preclude the participant from participating in the this study.
* Clinically significant aortic stenosis or mitral insufficiency as identified via echocardiography.
* History of myocardial infarction (MI), stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transient ischemic attack (TIA).

Other protocol defined inclusion/exclusion criteria may apply.

Where it's running

  • Quotient Sciences Sea View
    Miami, Florida, United States     Recruiting
  • Novartis Investigative Site
    Berlin, Germany     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.