GoutPhase 1NCT05745727
A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels
A Phase 1 study testing PRX-115 in people with Gout, run by Protalix at 2 sites in New Zealand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gout
- What is being tested?
- PRX-115
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 23 Mar 2023to 6 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18 to 65 years of age, inclusive.
- Serum uric acid greater than 6.0 mg/dL (0.35 mmol/L) at the Screening visit.
- Body mass index within the range 18.5 to 40 kg/m^2, inclusive, at the Screening visit.
- Women of childbearing potential may be included only if they have a negative beta human chorionic gonadotropin (β-hCG) test result at Screening.
- Men and women of childbearing potential and their partners should use double barrier contraception.
Who cannot join
- Has any condition known to have arthritis as a clinical manifestation
- Had greater than or equal to 1 gout flare in the last year prior to either Screening or Day -1.
- Has clinical evidence of subcutaneous tophi at either Screening or Day -1.
- Estimated glomerular filtration rate (eGFR) value less than or equal to 60 mL/min/1.73m^2
- History of significant renal disease, and/or presence of renal stones at either Screening or Day -1.
- Has a history of anaphylaxis, severe allergic reactions, or severe atopy.
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- History of autoimmune disorders, and/or participant is immunocompromised or treated with immunosuppressive medications.
- Has evidence of cardiovascular or cerebrovascular disease.
- History of congestive heart failure, New York Heart Association Class III or IV.
- BP outside the range of 90 to 150 mm Hg for systolic or 50 to 95 mm Hg for diastolic.
- Participants with hypertension who are not on stable medication for at least 6 months.
- Has uncontrolled type 2 diabetes
- Concurrent treatment with urate lowering drugs (ULDs).
- Prior exposure to any experimental or marketed uricase (eg, rasburicase [Elitek, Fasturtec], pegloticase [Krystexxa®], pegadricase [SEL-212]).
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency or known catalase deficiency.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
New Zealand Clinical Research
Christchurch, Christchurch, 8011
New Zealand Clinical Research
Grafton, Auckland, 1010
About this study
Official title: A Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels.
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.
Read the detailed 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.
- Conditions
- Gout
- Being tested
- PRX-115, Placebo
- Keywords
- Uricase, Gout, Uric acid, PRX-115, hyperuricemia
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX-115Drug
Also called Escalating doses of PRX-115
Escalating doses of PRX-115 will be given in different cohorts i.e., Cohorts 1 through 8
PlaceboDrug
Also called Placebo to match
Escalating doses of Placebo will be given in different cohorts i.e., Cohorts 1 through 8
| Study group | Role | What they receive |
|---|---|---|
| PRX-115 | Experimental | Participants will receive a single dose of PRX-115 by IV infusion Receives: Drug: PRX-115 |
| Placebo | Placebo comparator | Participants will receive a single dose of placebo by IV infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events receiving PRX-115 compared to placebo
To assess the safety and tolerability of a single infusion of PRX-115 as assessed by frequency of drug related adverse events, graded by severity.
Measured: Day 0 - Day 85
Number of participants with abnormal clinically significant clinical laboratory results
Clinical laboratory tests include hematology, coagulation and biochemistry
Measured: Day 0 - Day 85
Number of participants with abnormal clinical vital signs
Vital signs include pulse rate, blood pressure, respiratory rate and tympanic temperature
Measured: Day 0 - Day 85
Number of participants with abnormal clinically significant results from physical examination
Measured: Day 0 - Day 85
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Measured: Day 0 - Day 85
Secondary outcomes (9)
PK of PRX-115: Maximum observed plasma drug concentration (Cmax)
The Cmax PK parameter calculated based on the observed plasma drug concentration versus time curve
Measured: Day 1 - Day 85
PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-t)
The PK parameter calculated will be Area under the plasma drug concentration-time curve of the last measurable drug concentration (AUC0-t).
Measured: Day 1 - Day 85
PK of PRX-115: Time to maximum observed plasma drug concentration (Tmax)
The PK parameter calculated will be Time to maximum observed plasma drug concentration (T max).
Measured: Day 1 - Day 85
PK of PRX-115: total body clearance (CL)
The PK parameter calculated will be total body clearance (CL).
Measured: Day 1 - Day 85
PK of PRX-115: volume of distribution during the terminal phase (Vd)
The PK parameter calculated will be volume of distribution during the terminal phase (Vd).
Measured: Day 1 - Day 85
PK of PRX-115: Terminal elimination half-life (T ½)
The PK parameter of Terminal elimination half-life (T ½) is calculated based on the plasma drug concentration-time curve
Measured: Day 1 - Day 85
PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-inf)
The PK parameters calculated will be Area under the plasma drug concentration-time curve from time 0 to infinity (AUC0-inf).
Measured: Day 1 - Day 85
Pharmacodynamics of PRX-115: blood uric acid levels
Pharmacodynamics of PRX-115 by measurement of blood uric acid levels over 85 days
Measured: Day 0 - Day 85
Immunogenicity of PRX-115: measurement of anti-drug antibody levels
Measured: Day 1 - Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start23 Mar 2023
- Primary completion26 Aug 2024
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protalix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Marshall, Dr., Principal investigator, New Zealand Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745727
- Sponsor's protocol ID
- PB115-SAD-101
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2023
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels.
- ClinicalTrials.gov ID
- NCT05745727
- Acronym / sponsor ID
- PB115-SAD-101
- Conditions
- Gout
- Keywords
- Uricase, Gout, Uric acid, PRX-115, hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- ProtalixIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRX-115 | Experimental | Drug: PRX-115Participants will receive a single dose of PRX-115 by IV infusion |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of placebo by IV infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females 18 to 65 years of age, inclusive.
- Serum uric acid greater than 6.0 mg/dL (0.35 mmol/L) at the Screening visit.
- Body mass index within the range 18.5 to 40 kg/m^2, inclusive, at the Screening visit.
- Women of childbearing potential may be included only if they have a negative beta human chorionic gonadotropin (β-hCG) test result at Screening.
- Men and women of childbearing potential and their partners should use double barrier contraception.
Key exclusion criteria (15 listed)
- Has any condition known to have arthritis as a clinical manifestation
- Had greater than or equal to 1 gout flare in the last year prior to either Screening or Day -1.
- Has clinical evidence of subcutaneous tophi at either Screening or Day -1.
- Estimated glomerular filtration rate (eGFR) value less than or equal to 60 mL/min/1.73m^2
- History of significant renal disease, and/or presence of renal stones at either Screening or Day -1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRX-115Also: Escalating doses of PRX-115Escalating doses of PRX-115 will be given in different cohorts i.e., Cohorts 1 through 8 | Drug | PRX-115 |
| PlaceboAlso: Placebo to matchEscalating doses of Placebo will be given in different cohorts i.e., Cohorts 1 through 8 | Drug | Placebo |
Primary outcome
Number of participants with adverse events receiving PRX-115 compared to placebo
Time frame: Day 0 - Day 85
To assess the safety and tolerability of a single infusion of PRX-115 as assessed by frequency of drug related adverse events, graded by severity.
Number of participants with abnormal clinically significant clinical laboratory results
Time frame: Day 0 - Day 85
Clinical laboratory tests include hematology, coagulation and biochemistry
Number of participants with abnormal clinical vital signs
Time frame: Day 0 - Day 85
Vital signs include pulse rate, blood pressure, respiratory rate and tympanic temperature
Number of participants with abnormal clinically significant results from physical examination
Time frame: Day 0 - Day 85
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Time frame: Day 0 - Day 85
9 secondary outcomes
PK of PRX-115: Maximum observed plasma drug concentration (Cmax)
Time frame: Day 1 - Day 85
PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-t)
Time frame: Day 1 - Day 85
PK of PRX-115: Time to maximum observed plasma drug concentration (Tmax)
Time frame: Day 1 - Day 85
PK of PRX-115: total body clearance (CL)
Time frame: Day 1 - Day 85
PK of PRX-115: volume of distribution during the terminal phase (Vd)
Time frame: Day 1 - Day 85
PK of PRX-115: Terminal elimination half-life (T ½)
Time frame: Day 1 - Day 85
PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-inf)
Time frame: Day 1 - Day 85
Pharmacodynamics of PRX-115: blood uric acid levels
Time frame: Day 0 - Day 85
Immunogenicity of PRX-115: measurement of anti-drug antibody levels
Time frame: Day 1 - Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Marshall, Dr. principal investigator
New Zealand Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRX-115 in people with Gout, run by Protalix at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events receiving PRX-115 compared to placebo (time frame: Day 0 - Day 85). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.