NCT06310967 is a Phase 1/Phase 2 clinical trial of IG3018 in Hyperuricemia, sponsored by Intelligem Therapeutics Australia Pty Ltd..

Who is sponsoring NCT06310967?

NCT06310967 is sponsored by Intelligem Therapeutics Australia Pty Ltd..

What drugs are being tested in NCT06310967?

Interventions in NCT06310967: IG3018, Placebo matching IG3018.

What condition does NCT06310967 study?

NCT06310967 studies Hyperuricemia, Hypouricemia, Renal.

Is NCT06310967 still recruiting?

NCT06310967 is currently recruiting now. Last updated 1 February 2026.

Last reviewed 2026-02-01 · How we verify

NCT06310967

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Dose Escalation Study of IG3018 to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics in Subjects With Hyperuricemia With or Without Chronic Kidney Disease

Recruiting now Phase 1/Phase 2 Last updated 1 February 2026

What this trial tests

Phase 1/Phase 2 trial testing IG3018 in Hyperuricemia in 60 participants. Currently enrolling.

Timeline

12 November 2024

Primary endpoint
1 July 2026

1 January 2027

Quick facts

Lead sponsor	Intelligem Therapeutics Australia Pty Ltd.
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	12 November 2024
Primary completion	1 July 2026
Estimated completion	1 January 2027
Sites	6 locations across Australia, Taiwan

Drugs / interventions tested

IG3018 — full drug profile →
Placebo matching IG3018

Conditions studied

Hyperuricemia — all drugs for Hyperuricemia →
Hypouricemia, Renal — all drugs for Hypouricemia, Renal →

Sponsor

Intelligem Therapeutics Australia Pty Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Hyperuricemia or Hypouricemia, Renal. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety Assessments (Part 1 and Part 2)
Time frame: Baseline through study completion at up to 46 days
Safety as assessed by incidence of reported adverse events, clinically significant changes in vital signs, physical examination, laboratory tests, 12-lead ECG. Safety as assessed by incidence of AEs by using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5).
The proportions of change from baseline in serum uric acid to normal level (≤ 0.36 mmol/L) (Part 1 and Part 2)
Time frame: 4 weeks
The proportions of change from baseline in serum uric acid to normal level (≤ 0.36 mmol/L) following 4 weeks treatment with IG3018 in each dose.

Sponsor's own description

This is a phase I/II clinical study to evaluate the safety, tolerability, PK, and efficacy of IG3018 tablet in hyperuricemia (HUA) subjects with or without CKD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Hyperuricemia

Currently open trials in the same condition.

NCT07144332 — This Study is to Estimate the Efficacy of Hemodialysis Alone for Uric Acid Clearance in Patients on Hemodialysis. In Ord · recruiting
NCT07400549 — Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support T · NA · recruiting
NCT06859073 — A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia · Phase 1 · recruiting
NCT06463561 — CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea · Phase 4 · recruiting
NCT06729853 — PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function · Phase 1, PHASE2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06310967 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Intelligem Therapeutics Australia Pty Ltd.
Last refreshed: 1 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06310967.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing