New kidney drug enters first human tests

NCT ID NCT07235059

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 20, 2026 · Updated 5 times

Summary

This early-stage trial tests a new drug called OJR520 in healthy volunteers and people with chronic kidney disease. The main goal is to check if the drug is safe and how the body processes it. About 112 participants will receive either OJR520 or a placebo. This is the first time the drug is being tested in humans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OJR520
What this could lead to
If this drug is safe and shows promise, it could point toward a new treatment option for chronic kidney disease.
What could go wrong
This is a very early, first-in-human trial with only 112 participants. The drug may not work or could have side effects. It will take years to know if it helps patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 112 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Berlin, 10117, Germany

  • Quotient Sciences Sea View

    RECRUITING

    Miami, Florida, 33126, United States

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