Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease

Purpose

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

Condition

  • Chronic Kidney Disease

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: OJR520 dose A1
Participants will receive OJR520 dose level A1.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part A: OJR520 dose A2
Participants will receive OJR520 dose level A2.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part A: OJR520 dose A3
Participants will receive OJR520 dose level A3.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part A: OJR520 dose A4
Participants will receive OJR520 dose level A4.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part A: OJR520 dose A5
Participants will receive OJR520 dose level A5.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part A: OJR520 dose A6
Participants will receive OJR520 dose level A6.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part B: OJR520 dose B1
Participants will receive OJR520 dose level B1.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part B: OJR520 dose B2
Participants will receive OJR520 dose level B2.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part B: OJR520 dose B3
Participants will receive OJR520 dose level B3.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part B: OJR520 dose B4
Participants will receive OJR520 dose level B4.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part C: OJR520 dose C1
Participants will receive OJR520 dose level C1.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part C: OJR520 dose C2
Participants will receive OJR520 dose level C2.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part C: OJR520 dose C3
Participants will receive OJR520 dose level C3.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Experimental
Part C: OJR520 dose C4
Participants will receive OJR520 dose level C4.
  • Drug: OJR520
    Participants will receive OJR520 in different dose levels.
Placebo Comparator
Part A: Placebo
Participants will receive the matching placebo.
  • Other: Placebo
    Participants will receive OJR520 matching placebo.
Placebo Comparator
Part B: Placebo
Participants will receive the matching placebo.
  • Other: Placebo
    Participants will receive OJR520 matching placebo.
Placebo Comparator
Part C: Placebo
Participants will receive the matching placebo.
  • Other: Placebo
    Participants will receive OJR520 matching placebo.

Recruiting Locations

Quotient Sciences Sea View
Miami, Florida 33126
Contact:
Arline Mata
305-644-9903
arline.mata@quotientsciences.com

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

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.