OJR520 for Chronic Kidney Disease

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Cancer, Heart failure, Autoimmune CKD, others

Compensation: Varies

Number of Visits: Unknown

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new treatment called OJR520 for individuals with chronic kidney disease (CKD). The primary goal is to assess the treatment's safety and how the body processes it. Participants will receive varying doses of OJR520 or a placebo (a harmless pill without the active drug) to compare effects. This trial suits adults with CKD who have not undergone a kidney transplant or dialysis and have not experienced recent heart problems, such as a heart attack or stroke. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that OJR520 is likely to be safe for humans?

A previous study tested OJR520 on both healthy volunteers and individuals with chronic kidney disease to assess its safety and tolerability. Since this marks the first human testing of the drug, researchers are still collecting safety information.

Currently, the treatment is administered in small doses to closely monitor for any side effects. This careful approach is standard when testing a drug in humans for the first time. The study aims to determine if OJR520 causes any negative health effects and their potential severity.

Detailed reports on side effects or tolerability are not yet available. As the treatment remains in the early testing phase, researchers continue to gather safety evidence. Participants in these trials receive close monitoring to ensure their safety as more information emerges. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic kidney disease?

Researchers are excited about OJR520 for chronic kidney disease because it represents a new approach compared to current treatments like ACE inhibitors, angiotensin II receptor blockers (ARBs), and diuretics. Unlike these standard therapies, which primarily focus on managing symptoms and slowing disease progression, OJR520 may work by targeting specific pathways involved in kidney damage. This novel mechanism could potentially offer a more direct way to preserve kidney function and improve outcomes for patients. Additionally, the study is exploring multiple dosing levels, which might help determine the most effective and safe dosage for patients.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

Research into OJR520 focuses on its potential to aid individuals with chronic kidney disease. Early findings suggest that OJR520 might influence certain bodily processes related to kidney function, potentially slowing kidney damage. In this trial, participants will receive varying doses of OJR520 or a placebo to evaluate its safety and absorption. Although human studies are limited, scientists remain hopeful because OJR520 has shown promise in early lab studies. This could lead to a new, effective treatment option for chronic kidney disease in the future. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 65, as well as those with Chronic Kidney Disease (CKD). Participants must be in good health based on medical history, physical exams, vital signs, ECGs, and lab tests. They need to give written consent before any assessments.

Inclusion Criteria

I have chronic kidney disease.

I am between 18 and 65 years old.

I can sign a consent form before any tests are done.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of OJR520 or placebo

4 weeks

Multiple visits (in-person)

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of OJR520 or placebo

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OJR520

Trial Overview The study is testing OJR520's safety and how the body absorbs and processes it. It's a first-in-human study comparing OJR520 against a placebo in both healthy volunteers and people with CKD.

How Is the Trial Designed?

Group I: Part C: OJR520 dose C4 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level C4.

Group II: Part C: OJR520 dose C3 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level C3.

Group III: Part C: OJR520 dose C2 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level C2.

Group IV: Part C: OJR520 dose C1 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level C1.

Group V: Part B: OJR520 dose B4 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level B4.

Group VI: Part B: OJR520 dose B3 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level B3.

Group VII: Part B: OJR520 dose B2 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level B2.

Group VIII: Part B: OJR520 dose B1 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level B1.

Group IX: Part A: OJR520 dose A6 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level A6.

Group X: Part A: OJR520 dose A5 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level A5.

Group XI: Part A: OJR520 dose A4 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level A4.

Group XII: Part A: OJR520 dose A3 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level A3.

Group XIII: Part A: OJR520 dose A2 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level A2.

Group XIV: Part A: OJR520 dose A1 Experimental Treatment 1 Intervention

Participants will receive OJR520 dose level A1.

Group XV: Part B: Placebo Placebo Group 1 Intervention

Participants will receive the matching placebo.

Group XVI: Part C: Placebo Placebo Group 1 Intervention

Participants will receive the matching placebo.

Group XVII: Part A: Placebo Placebo Group 1 Intervention

Participants will receive the matching placebo.

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07235059

Study Details | NCT07235059 | Safety, Tolerability, ... The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520. Detailed Description. This ...

2. novartis.com novartis.com/clinicaltrials/study/nct07235059

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

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07235059?aggFilters=status%3Anot

Study Details | NCT07235059 | Safety, Tolerability, ... The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520. Detailed Description. This is a three-part ...

4. novartis.com novartis.com/sites/novartiscom/files/2024-10-novartis-renal-portfolio-presentation.pdf

Novartis Renal Portfolio Investor Event Iptacopan is the INN (international non-proprietary name) of Fabhalta for unapproved indications. 19k4,6. ~50% patients progress to kidney.

5. reporter.nih.gov reporter.nih.gov/search/t_kbDTVMR0KOnhtdmsXJ0w/project-details/11125843

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

6. reporter.nih.gov reporter.nih.gov/search/GCtV6LXGoUKEhVf-TaP9GQ/project-details/11125843

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. synapse.patsnap.com synapse.patsnap.com/drug/885a550359b447a5b4db7abb99673fff

OJR520 - Drug Targets, Indications, Patents ... Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease. 100 Clinical ...