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
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • OJR520 — DRUG
    Participants will receive OJR520 in different dose levels.
  • Placebo — OTHER
    Participants 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

First listed
Nov 19, 2025
Start date
Nov 20, 2025
Status verified
Aug 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 A1
    Participants will receive OJR520 dose level A1.
  • Experimental: Part A: OJR520 dose A2
    Participants will receive OJR520 dose level A2.
  • Experimental: Part A: OJR520 dose A3
    Participants will receive OJR520 dose level A3.
  • Experimental: Part A: OJR520 dose A4
    Participants will receive OJR520 dose level A4.
  • Experimental: Part A: OJR520 dose A5
    Participants will receive OJR520 dose level A5.
  • Experimental: Part A: OJR520 dose A6
    Participants will receive OJR520 dose level A6.
  • Experimental: Part B: OJR520 dose B1
    Participants will receive OJR520 dose level B1.
  • Experimental: Part B: OJR520 dose B2
    Participants will receive OJR520 dose level B2.
  • Experimental: Part B: OJR520 dose B3
    Participants will receive OJR520 dose level B3.
  • Experimental: Part B: OJR520 dose B4
    Participants will receive OJR520 dose level B4.
  • Experimental: Part C: OJR520 dose C1
    Participants will receive OJR520 dose level C1.
  • Experimental: Part C: OJR520 dose C2
    Participants will receive OJR520 dose level C2.
  • Experimental: Part C: OJR520 dose C3
    Participants will receive OJR520 dose level C3.
  • Experimental: Part C: OJR520 dose C4
    Participants will receive OJR520 dose level C4.
  • Placebo Comparator: Part A: Placebo
    Participants will receive the matching placebo.
  • Placebo Comparator: Part B: Placebo
    Participants will receive the matching placebo.
  • Placebo Comparator: Part C: Placebo
    Participants 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 Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (1)

FacilityCityStateZIPSite coordinators
Quotient Sciences Sea ViewMiamiFlorida33126
Daniela Perez
[email protected]
+1 305 644 9903
Juliet Vento (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

Nationwide
Chronic kidney disease trialsNephrology trialsKidney disease trials
By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Quotient Sciences Sea View· Miami, FL

Related Studies