OJR520 safety and dose testing in healthy people and adults with chronic kidney disease
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
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).
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT07235059 on ClinicalTrials.gov |
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.
Who should consider this trial
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).
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Miami, Florida and 1 other locations
- Quotient Sciences Sea View — Miami, Florida, United States (Recruiting)
- Novartis Investigative Site — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.