Image

A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels

Recruiting
18 - 65 years of age
Both
Phase 1

Powered by AI

Overview

This is a Phase 1, double-blind, placebo-controlled, single ascending dose study in participants with elevated uric acid levels. This study will be conducted in approximately 64 adult male and female participants in the dose escalation phase.

Description

Participants will be assigned to 1 of 8 sequential dosing cohorts, each composed of 8 participants (6 active + 2 placebo) who will receive a single dose of PRX-115 or placebo by intravenous (IV) infusion.

Eligibility

Inclusion Criteria:

  1. Males or females 18 to 65 years of age, inclusive.
  2. Serum uric acid greater than 6.0 mg/dL (0.35 mmol/L) at the Screening visit.
  3. Body mass index within the range 18.5 to 40 kg/m^2, inclusive, at the Screening visit.
  4. Women of childbearing potential may be included only if they have a negative beta human chorionic gonadotropin (β-hCG) test result at Screening.
  5. Men and women of childbearing potential and their partners should use double barrier contraception.

Exclusion Criteria:

  1. Has any condition known to have arthritis as a clinical manifestation
  2. Had greater than or equal to 1 gout flare in the last year prior to either Screening or Day -1.
  3. Has clinical evidence of subcutaneous tophi at either Screening or Day -1.
  4. Estimated glomerular filtration rate (eGFR) value less than or equal to 60 mL/min/1.73m^2
  5. History of significant renal disease, and/or presence of renal stones at either Screening or Day -1.
  6. Has a history of anaphylaxis, severe allergic reactions, or severe atopy.
  7. History of autoimmune disorders, and/or participant is immunocompromised or treated with immunosuppressive medications.
  8. Has evidence of cardiovascular or cerebrovascular disease.
  9. History of congestive heart failure, New York Heart Association Class III or IV.
  10. BP outside the range of 90 to 150 mm Hg for systolic or 50 to 95 mm Hg for diastolic.
  11. Participants with hypertension who are not on stable medication for at least 6 months.
  12. Has uncontrolled type 2 diabetes
  13. Concurrent treatment with urate lowering drugs (ULDs).
  14. Prior exposure to any experimental or marketed uricase (eg, rasburicase [Elitek, Fasturtec], pegloticase [Krystexxa®], pegadricase [SEL-212]).
  15. Glucose-6-phosphate dehydrogenase (G6PD) deficiency or known catalase deficiency.

Study details

Gout

NCT05745727

Protalix

20 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.