Health Trials

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

ConditionChronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • OJR520
  • Placebo

Treatment groups

112 Participants
are divided into 17 treatment groups

17

Treatment groups

See each treatment group below.

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov