Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07235059
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- OJR520 — DRUGParticipants will receive OJR520 in different dose levels.
- Placebo — OTHERParticipants will receive OJR520 matching placebo.
Study Details
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
Key Dates
- Start date
- Nov 20, 2025
- Status verified
- May 2026
- Primary completion
- Jan 21, 2028
- Completion
- Jan 21, 2028
Study Design
- Enrollment
- 112 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part A: OJR520 dose A1Participants will receive OJR520 dose level A1.
- Experimental: Part A: OJR520 dose A2Participants will receive OJR520 dose level A2.
- Experimental: Part A: OJR520 dose A3Participants will receive OJR520 dose level A3.
- Experimental: Part A: OJR520 dose A4Participants will receive OJR520 dose level A4.
- Experimental: Part A: OJR520 dose A5Participants will receive OJR520 dose level A5.
- Experimental: Part A: OJR520 dose A6Participants will receive OJR520 dose level A6.
- Experimental: Part B: OJR520 dose B1Participants will receive OJR520 dose level B1.
- Experimental: Part B: OJR520 dose B2Participants will receive OJR520 dose level B2.
- Experimental: Part B: OJR520 dose B3Participants will receive OJR520 dose level B3.
- Experimental: Part B: OJR520 dose B4Participants will receive OJR520 dose level B4.
- Experimental: Part C: OJR520 dose C1Participants will receive OJR520 dose level C1.
- Experimental: Part C: OJR520 dose C2Participants will receive OJR520 dose level C2.
- Experimental: Part C: OJR520 dose C3Participants will receive OJR520 dose level C3.
- Experimental: Part C: OJR520 dose C4Participants will receive OJR520 dose level C4.
- Placebo Comparator: Part A: PlaceboParticipants will receive the matching placebo.
- Placebo Comparator: Part B: PlaceboParticipants will receive the matching placebo.
- Placebo Comparator: Part C: PlaceboParticipants will receive the matching placebo.
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) ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Quotient Sciences Sea View | Miami | Florida | 33126 | Juliet Vento (PRINCIPAL_INVESTIGATOR) |
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