Chronic Kidney DiseasePhase 1NCT07235059
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
A Phase 1 study testing OJR520 in people with Chronic Kidney Disease, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- OJR520
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Nov 2025to 21 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Quotient Sciences Sea View
Miami, Florida, 33126
Daniela Perez, +1 305 644 9903, daniela.perez@quotientsciences.com
Juliet Vento
Germany1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Berlin, 10117
About this study
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
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
Read the detailed description
This is a three-part randomized, participant- and investigator blinded, placebo-controlled, multi-center, sequential study: single ascending dose (SAD) in healthy volunteers (HV), SAD in participants with chronic kidney disease (CKD) or diabetic chronic kidney disease (DKD) and multiple ascending dose (MAD) in participants with CKD or DKD.
- Conditions
- Chronic Kidney Disease
- Being tested
- OJR520, Placebo
- Keywords
- OJR520, safety and tolerability, PK, PD, healthy volunteers, first in human, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OJR520Drug
Participants will receive OJR520 in different dose levels.
PlaceboOther
Participants will receive OJR520 matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Part A: OJR520 dose A1 | Experimental | Participants will receive OJR520 dose level A1. Receives: Drug: OJR520 |
| Part A: OJR520 dose A2 | Experimental | Participants will receive OJR520 dose level A2. Receives: Drug: OJR520 |
| Part A: OJR520 dose A3 | Experimental | Participants will receive OJR520 dose level A3. Receives: Drug: OJR520 |
| Part A: OJR520 dose A4 | Experimental | Participants will receive OJR520 dose level A4. Receives: Drug: OJR520 |
| Part A: OJR520 dose A5 | Experimental | Participants will receive OJR520 dose level A5. Receives: Drug: OJR520 |
| Part A: OJR520 dose A6 | Experimental | Participants will receive OJR520 dose level A6. Receives: Drug: OJR520 |
| Part B: OJR520 dose B1 | Experimental | Participants will receive OJR520 dose level B1. Receives: Drug: OJR520 |
| Part B: OJR520 dose B2 | Experimental | Participants will receive OJR520 dose level B2. Receives: Drug: OJR520 |
| Part B: OJR520 dose B3 | Experimental | Participants will receive OJR520 dose level B3. Receives: Drug: OJR520 |
| Part B: OJR520 dose B4 | Experimental | Participants will receive OJR520 dose level B4. Receives: Drug: OJR520 |
| Part C: OJR520 dose C1 | Experimental | Participants will receive OJR520 dose level C1. Receives: Drug: OJR520 |
| Part C: OJR520 dose C2 | Experimental | Participants will receive OJR520 dose level C2. Receives: Drug: OJR520 |
| Part C: OJR520 dose C3 | Experimental | Participants will receive OJR520 dose level C3. Receives: Drug: OJR520 |
| Part C: OJR520 dose C4 | Experimental | Participants will receive OJR520 dose level C4. Receives: Drug: OJR520 |
| Part A: Placebo | Placebo comparator | Participants will receive the matching placebo. Receives: Other: Placebo |
| Part B: Placebo | Placebo comparator | Participants will receive the matching placebo. Receives: Other: Placebo |
| Part C: Placebo | Placebo comparator | Participants will receive the matching placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Measured: From Day 1 (Part A) until Day 71 (Part C)
Secondary outcomes (9)
Maximum Observed Blood Concentrations (Cmax)
Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1).
Measured: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Time to reach maximum plasma concentration (Tmax)
Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time).
Measured: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Area under plasma concentration-time curve (AUClast)
AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast).
Measured: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Area under the plasma concentration-time curve (AUC[0-inf])
The AUC[0-inf] from time zero extrapolated to infinity (mass x time x volume-1).
Measured: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Terminal elimination half-life (T1/2)
T1/2 is the elimination half-life associated with the terminal slope.
Measured: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Apparent plasma clearance (CL/F)
CL/F is the apparent total body clearance of drug from plasma following extravascular administration.
Measured: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Apparent volume of distribution during terminal elimination phase (Vz/F)
Vz/F is the apparent volume of distribution during terminal elimination phase following extravascular administration.
Measured: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Drug accumulation ratio (Racc)
The ratio of accumulation of drug between the first and last dose, only for MAD part of the study.
Measured: Part C: From pre-dose Day 1 until Day 71
Area under plasma concentration-time curve (AUCtau)
The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1) only for MAD part of the study.
Measured: Part C: From pre-dose Day 1 until Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start20 Nov 2025
- Primary completion21 Jan 2028 (estimated)
- Study completion21 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235059
- Sponsor's protocol ID
- COJR520A12101
- Other IDs
- 2025-520978-18, 2025
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07235059
- Acronym / sponsor ID
- COJR520A12101
- Conditions
- Chronic Kidney Disease
- Keywords
- OJR520, safety and tolerability, PK, PD, healthy volunteers, first in human, chronic kidney disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 21 Jan 2028 (estimated)
- Study completion
- 21 Jan 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 randomized, participant- and investigator blinded, placebo-controlled, multi-center, sequential study: single ascending dose (SAD) in healthy volunteers (HV), SAD in participants with chronic kidney disease (CKD) or diabetic chronic kidney disease (DKD) and multiple ascending dose (MAD) in participants with CKD or DKD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Part A: OJR520 dose A1 | Experimental | Drug: OJR520Participants will receive OJR520 dose level A1. |
| Part A: OJR520 dose A2 | Experimental | Drug: OJR520Participants will receive OJR520 dose level A2. |
| Part A: OJR520 dose A3 | Experimental | Drug: OJR520Participants will receive OJR520 dose level A3. |
| Part A: OJR520 dose A4 | Experimental | Drug: OJR520Participants will receive OJR520 dose level A4. |
| Part A: OJR520 dose A5 | Experimental | Drug: OJR520Participants will receive OJR520 dose level A5. |
| Part A: OJR520 dose A6 | Experimental | Drug: OJR520Participants will receive OJR520 dose level A6. |
| Part B: OJR520 dose B1 | Experimental | Drug: OJR520Participants will receive OJR520 dose level B1. |
| Part B: OJR520 dose B2 | Experimental | Drug: OJR520Participants will receive OJR520 dose level B2. |
| Part B: OJR520 dose B3 | Experimental | Drug: OJR520Participants will receive OJR520 dose level B3. |
| Part B: OJR520 dose B4 | Experimental | Drug: OJR520Participants will receive OJR520 dose level B4. |
| Part C: OJR520 dose C1 | Experimental | Drug: OJR520Participants will receive OJR520 dose level C1. |
| Part C: OJR520 dose C2 | Experimental | Drug: OJR520Participants will receive OJR520 dose level C2. |
| Part C: OJR520 dose C3 | Experimental | Drug: OJR520Participants will receive OJR520 dose level C3. |
| Part C: OJR520 dose C4 | Experimental | Drug: OJR520Participants will receive OJR520 dose level C4. |
| Part A: Placebo | Placebo comparator | Other: PlaceboParticipants will receive the matching placebo. |
| Part B: Placebo | Placebo comparator | Other: PlaceboParticipants will receive the matching placebo. |
| Part C: Placebo | Placebo comparator | Other: PlaceboParticipants will receive the matching placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide written informed consent before any assessment is performed.
- 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.
Key exclusion criteria (10 listed)
- Women of childbearing potential.
- Sexually active males unwilling to use contraception.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OJR520Participants will receive OJR520 in different dose levels. | Drug | Part A: OJR520 dose A1, Part A: OJR520 dose A2, Part A: OJR520 dose A3, Part A: OJR520 dose A4, Part A: OJR520 dose A5, Part A: OJR520 dose A6, Part B: OJR520 dose B1, Part B: OJR520 dose B2, Part B: OJR520 dose B3, Part B: OJR520 dose B4, Part C: OJR520 dose C1, Part C: OJR520 dose C2, Part C: OJR520 dose C3, Part C: OJR520 dose C4 |
| PlaceboParticipants will receive OJR520 matching placebo. | Other | Part A: Placebo, Part B: Placebo, Part C: Placebo |
Primary outcome
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Time frame: From Day 1 (Part A) until Day 71 (Part C)
Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
9 secondary outcomes
Maximum Observed Blood Concentrations (Cmax)
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Time to reach maximum plasma concentration (Tmax)
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Area under plasma concentration-time curve (AUClast)
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Area under the plasma concentration-time curve (AUC[0-inf])
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Terminal elimination half-life (T1/2)
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Apparent plasma clearance (CL/F)
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Apparent volume of distribution during terminal elimination phase (Vz/F)
Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)
Drug accumulation ratio (Racc)
Time frame: Part C: From pre-dose Day 1 until Day 71
Area under plasma concentration-time curve (AUCtau)
Time frame: Part C: From pre-dose Day 1 until Day 71
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OJR520 in people with Chronic Kidney Disease, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) (time frame: From Day 1 (Part A) until Day 71 (Part C)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.