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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06310967




Registration number
NCT06310967
Ethics application status
Date submitted
3/03/2024
Date registered
15/03/2024

Titles & IDs
Public title
A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease
Scientific title
A Dose Escalation Study of IG3018 to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics in Subjects With Hyperuricemia With or Without Chronic Kidney Disease
Secondary ID [1] 0 0
IG3018-23-02-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperuricemia 0 0
Hypouricemia, Renal 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IG3018
Other interventions - Placebo matching IG3018

Other: Cohort A (0.25 g tablets) - Cohort A will have 10 eligible patients. 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort.

Dose shall be at 0.25 g tablets. Single-dose initial treatment phase: D1\~D3. Subject will receive a single dose of IG3018 or the placebo on Day 1. The predetermined information shall be collected in the form of blood and urine samples for PK analyses, whilst efficacy and safety assessment data will be collected within 48 hours after the single dose of study drug administration (IG3018 or placebo).

Maintenance treatment on daily basis phase: 4 weeks. Subjects in this maintenance treatment phase shall receive the study drug IG3018 in twice daily dosing for 28 days from Day 4 to Day 31, and will be given IG3018 once on the morning of D32.

Other: Cohort B (0.5 g tablets) - Cohort B will have 10 eligible patients. 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort.

Dose shall be at 0.5 g tablets. Single-dose initial treatment phase: D1\~D3. Subject will receive a single dose of IG3018 or the placebo on Day 1. The predetermined information shall be collected in the form of blood and urine samples for PK analyses, whilst efficacy and safety assessment data will be collected within 48 hours after the single dose of study drug administration (IG3018 or placebo).

Maintenance treatment on daily basis phase: 4 weeks. Subjects in this maintenance treatment phase shall receive the study drug IG3018 in twice daily dosing for 28 days from Day 4 to Day 31, and will be given IG3018 once on the morning of D32.

Other: Cohort C (1.0 g tablets) - Cohort C will have 10 eligible patients. 8 subjects will receive the active study drug (IG3018) and 2 shall receive placebo in each dose cohort.

Dose shall be at 1.0 g tablets. Single-dose initial treatment phase: D1\~D3. Subject will receive a single dose of IG3018 or the placebo on Day 1. The predetermined information shall be collected in the form of blood and urine samples for PK analyses, whilst efficacy and safety assessment data will be collected within 48 hours after the single dose of study drug administration (IG3018 or placebo).

Maintenance treatment on daily basis phase: 4 weeks. Subjects in this maintenance treatment phase shall receive the study drug IG3018 in twice daily dosing for 28 days from Day 4 to Day 31, and will be given IG3018 once on the morning of D32.

Other: Cohort D (0.5 g BID IG3018) - 5 to 8 hyperuricemia subjects with advanced CKD will be enrolled in Cohort D and will receive 0.5 g IG3018 twice daily (BID) for 4 weeks.

Other: Cohort E (1.0 g BID IG3018) - 5 to 8 hyperuricemia subjects with advanced CKD will be enrolled in Cohort E and will receive 1.0 g IG3018 twice daily (BID) for 4 weeks.


Treatment: Drugs: IG3018
Oral administration

Other interventions: Placebo matching IG3018
Oral administration
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Assessments (Part 1 and Part 2)
Timepoint [1] 0 0
Baseline through study completion at up to 46 days
Primary outcome [2] 0 0
The proportions of change from baseline in serum uric acid to normal level (= 0.36 mmol/L) (Part 1 and Part 2)
Timepoint [2] 0 0
4 weeks
Secondary outcome [1] 0 0
The proportions of change from baseline in serum uric acid to = 0.30 mmol/L and = 0.24 mmol/L respectively (Part 1 and Part 2)
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
The actual change of serum uric acid (Part 1 and Part 2)
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
The percentage change of serum uric acid (Part 1 and Part 2)
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Gouty Attacks (Part 1 and Part 2)
Timepoint [4] 0 0
Baseline through study completion at up to 46 days
Secondary outcome [5] 0 0
Urinary Albumin/Creatinine Ration (U-ACR) (Part 2 only)
Timepoint [5] 0 0
Baseline through study completion at up to 43 days
Secondary outcome [6] 0 0
Ae of IG3018 (Part 1 only)
Timepoint [6] 0 0
32 days
Secondary outcome [7] 0 0
Cmax of IG3018 (Part 1 only)
Timepoint [7] 0 0
46 days
Secondary outcome [8] 0 0
Tmax of IG3018 (Part 1 only)
Timepoint [8] 0 0
46 days
Secondary outcome [9] 0 0
T1/2 of IG3018 (Part 1 only)
Timepoint [9] 0 0
46 days

Eligibility
Key inclusion criteria
For Part 1 and Part 2:

Subjects must meet all the following criteria to be included in the study:

1. Male or female, aged 18 to 75 years (both inclusive).
2. According to the investigator's judgment, eGFR must be met as:

Part 1 only, subjects without CKD and have eGFR = 60 mL/minute/1.73 m2 at screening phase; Part 2 only, subjects with CKD (Stage 3a, 3b and Stage 4) have eGFR=15 and <60 mL/minute/1.73 m2 at screening phase.
3. The serum uric acid level for subjects need to meet any of the following:

For subjects already on ULT within 2 weeks prior to the screening visit, the serum uric acid would be measured during the screening visit/phase, and then at the end of the run-in phase, prior to confirming their eligibility. Subjects with ULT within 2 weeks before screening has fasting serum uric acid = 0.48 mmol/L at the end of run-in phase.

For subjects without ULT in 2 weeks prior to screening visit,the serum uric acid should be measured twice on 2 different days (at least 24 hours apart) prior to confirming their eligibility. Subjects without ULT within 2 weeks before screening has fasting serum uric acid = 0.48 mmol/L at screening phase.
4. Body Mass Index (BMI) = 18 and = 35 kg/m2 (both inclusive) at screening.
5. Female subjects of child-bearing potential must agree to use highly effective contraceptive methods and must abstain from egg collection or donation from the screening phase to 90 days after the last dose of the study drug. And the male partner of a female subject also needs to agree to use highly effective method of birth control during this phase (Appendix 1).
6. Male subjects considered fertile must agree to not donate sperm, and take effective contraceptive methods from the screening phase to 90 days after the last dose of the study drug. And the female partner of male subjects also needs to agree to use a highly effective method of female contraception during this phase (Appendix 1).
7. Able to understand and give signed written informed consent form and willing to comply with all study procedures.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For Part 1 and Part 2:

Subjects who meet any of the following criteria will be excluded from the study:

1. Prior uricase therapy or exposure to recombinant uricase, such as Rasburicase or Pegloticase.
2. Subject has acute gout flares requiring treatment within 3 months prior to or during Screening.
3. Major surgery within 3 months prior to the first administration.
4. History of malignant tumors within 6 months prior to screening.
5. Subject within the last 3 months has: myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemia attack.
6. Subject who are on other urate-lowering medication (allopurinol, febuxostat, probenecid and benzbromarone) and cannot stop during the study periods included in the run-in phase.
7. Subject with underlying medical conditions requiring changes or introduction of drugs that have the potential impact on the serum uric acid levels (e.g., salicylic acids, diuretics, angiotensin receptor blockers, etc.) within at least 1 month prior the screening phase.
8. History of gastrointestinal (GI) surgery, including gastric sleeve, colostomy/ enterostomy, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to Screening.
9. History of GI diseases, including gastrointestinal bleeding moderate to severe gastrointestinal dysfunction, moderate to severe chronic constipation for a minimum of 3 months prior to screening, or newly diagnosed peptic or duodenal ulcer diseases within 4 weeks prior to screening.
10. Chronic use of parenteral nutrition including manganese within 3 months prior to screening.
11. Subjects has the history of manganese toxicity or excessive exposure to manganese (i.e., having worked in a mine, foundry, smelter, dry cell battery manufacturing facility) within 2 months prior to screening.
12. Inability to swallow oral medications.
13. Received treatment with or exposure to an investigational drug or device within 30 days of signing informed consent.
14. Subject with one of positive results of HIV virus, or positive hepatitis B virus surface antigen (HBsAg) and the number of copies of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) = 500 IU/mL (or 2500 copies, or the lower limit of the positive detection value of the study site) at screening, or HBsAg (-), hepatitis B core antibody (HBcAb) (+) and the number of copies of HBV DNA = 500 IU/mL (or 2500 copies, or the lower limit of the positive detection value of the study site) after treatment of HBV infection, or positive hepatitis C antibody (HCV-Ab), and hepatitis C virus (HCV) ribonucleic acid (RNA) = ULN of the study site during Screening phase.
15. History of alcohol abuse, or subjects who consumed alcohol within 48 h before the first administration or did not agree to stop using alcohol products during the study.
16. Subject who has previously been diagnosed with the following diseases and have not been able to control them after medication therapy or other treatment. Uncontrolled is defined as hypertension: msSBP = 180mmHg and/or msDBP = 110mmHg; or Diabetes mellitus: HbA1c = 9% at screening.
17. Subject with secondary hyperuricemia caused by tumor, hematological system diseases, drugs, etc. except for chronic kidney disease; or hereditary hyperuricemia at screening.
18. Subjects undergone kidney transplantation or planning to undergo kidney transplantation at screening.
19. Subjects with abnormal biliary function, biliary obstruction, or biliary gallstone at screening.
20. Prior or current cholestatic liver disease defined as a clinical condition associated with decrease in bile flow due to impaired secretion by hepatocytes or to obstruction of bile flow through intra-or extrahepatic bile ducts.
21. History of serious hypersensitivity reaction to a known ingredient of IG3018 tablet judged by the investigator.
22. Subject who is considered unsuitable for participating in the study in the opinion of the investigator judgment.

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 administering the treatment/s
The people assessing the outcomes
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
12/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Emeritus Research Pty Ltd -Sydney - Botany
Recruitment hospital [2] 0 0
Pendlebury Research Pty Ltd T/A Novatrials - Kotara
Recruitment hospital [3] 0 0
Emeritus Research Pty Ltd -Melbourne - Camberwell
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2289 - Kotara
Recruitment postcode(s) [3] 0 0
3124 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Intelligem Therapeutics Australia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Operation Team
Address 0 0
Country 0 0
Phone 0 0
+8610 53688632
Fax 0 0
Email 0 0
clinicaltrials@intelligemtx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06310967