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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05745727




Registration number
NCT05745727
Ethics application status
Date submitted
3/02/2023
Date registered
27/02/2023
Date last updated
14/05/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels
Scientific 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.
Secondary ID [1] 0 0
PB115-SAD-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PRX-115
Treatment: Drugs - Placebo

Experimental: PRX-115 - Participants will receive a single dose of PRX-115 by IV infusion

Placebo Comparator: Placebo - Participants will receive a single dose of placebo by IV infusion


Treatment: Drugs: PRX-115
Escalating doses of PRX-115 will be given in different cohorts i.e., Cohorts 1 through 8

Treatment: Drugs: Placebo
Escalating doses of Placebo will be given in different cohorts i.e., Cohorts 1 through 8
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events receiving PRX-115 compared to placebo
Timepoint [1] 0 0
Day 0 - Day 85
Primary outcome [2] 0 0
Number of participants with abnormal clinically significant clinical laboratory results
Timepoint [2] 0 0
Day 0 - Day 85
Primary outcome [3] 0 0
Number of participants with abnormal clinical vital signs
Timepoint [3] 0 0
Day 0 - Day 85
Primary outcome [4] 0 0
Number of participants with abnormal clinically significant results from physical examination
Timepoint [4] 0 0
Day 0 - Day 85
Primary outcome [5] 0 0
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Timepoint [5] 0 0
Day 0 - Day 85
Secondary outcome [1] 0 0
PK of PRX-115: Maximum observed plasma drug concentration (Cmax)
Timepoint [1] 0 0
Day 1 - Day 85
Secondary outcome [2] 0 0
PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-t)
Timepoint [2] 0 0
Day 1 - Day 85
Secondary outcome [3] 0 0
PK of PRX-115: Time to maximum observed plasma drug concentration (Tmax)
Timepoint [3] 0 0
Day 1 - Day 85
Secondary outcome [4] 0 0
PK of PRX-115: total body clearance (CL)
Timepoint [4] 0 0
Day 1 - Day 85
Secondary outcome [5] 0 0
PK of PRX-115: volume of distribution during the terminal phase (Vd)
Timepoint [5] 0 0
Day 1 - Day 85
Secondary outcome [6] 0 0
PK of PRX-115: Terminal elimination half-life (T ½)
Timepoint [6] 0 0
Day 1 - Day 85
Secondary outcome [7] 0 0
PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-inf)
Timepoint [7] 0 0
Day 1 - Day 85
Secondary outcome [8] 0 0
Pharmacodynamics of PRX-115: blood uric acid levels
Timepoint [8] 0 0
Day 0 - Day 85
Secondary outcome [9] 0 0
Immunogenicity of PRX-115: measurement of anti-drug antibody levels
Timepoint [9] 0 0
Day 1 - Day 85

Eligibility
Key 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 (ß-hCG) test result at Screening.

5. Men and women of childbearing potential and their partners should use double barrier
contraception.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Protalix
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05745727
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Marshall, Dr.
Address 0 0
New Zealand Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Orit Cohen-Barak, PhD
Address 0 0
Country 0 0
Phone 0 0
+972-4-9052-8100
Fax 0 0
Email 0 0
Orit.Barak@protalix.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05745727