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A Study of IN026 in Participants With Refractory Gout

A Clinical Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of IN026 in the Treatment of Refractory Gout

The goal of this clinical study is to learn if IN026 Injection is safe and works to lower uric acid levels in adults with refractory gout (gout that does not respond well to standard treatments). The main questions it aims to answer are:

  • What medical problems do participants have when taking IN026, such as changes in vital signs, blood tests, or heart rhythm?
  • How does the body absorb, process, and respond to IN026, and does it trigger an immune reaction?
  • Does IN026 lower uric acid levels in the blood and reduce tophi?

Investigator will start with lower doses of IN026 and slowly increase the dose to find the well-tolerated dose.

Participants will:

  • Receive IN026 through an intravenous (IV) drip into a vein at a set dose.
  • Complete a screening period of up to 4 weeks, followed by treatment and check-ups for up to 20 weeks.
  • Have blood and urine samples taken at set times to check safety and how the body responds to IN026.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

16

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: QiuBai Li Union Hospital, Tongji Medical College, Huazhong University of
  • Numero di telefono: +86-27-85726338
  • Email: qiubaili@hust.edu.cn

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Can voluntarily sign the informed consent form (ICF) and comply with ICF and study protocol requirements.
  2. Male or female, 18-75 years old (inclusive) at screening.
  3. Meet 2015 ACR/EULAR gout classification criteria, in the intercritical phase of gout or acute flare resolved ≥2 weeks at screening.
  4. Serum uric acid ≥420 μmol/L (7 mg/dl) at screening.
  5. Meet the definition of refractory gout (poor uric acid control accompanied by severe gout symptoms)

Exclusion Criteria:

  1. Gout secondary to radiotherapy/chemotherapy, lead poisoning, organ transplantation, tumor, etc. at screening/baseline.
  2. Rheumatoid arthritis, infectious/septic arthritis, or other acute inflammatory arthritis at screening/baseline.
  3. Glucose-6-phosphate dehydrogenase (G6PD) deficiency history, or G6PD level below normal lower limit.
  4. Positive HBsAg; HCV antibody positive is excluded except those with sustained HCV-RNA negativity after standard treatment; HIV antibody positive; active syphilis.
  5. Presence of chronic liver diseases including active hepatitis, cirrhosis and alcoholic liver disease.
  6. Participants with a history of any of the following: serious cardiovascular diseases within 6 months prior to screening; or serious diseases of the digestive, respiratory, urinary, musculoskeletal, neuropsychiatric, hematological, or immune systems within 3 months prior to screening.
  7. Prolonged QTcF at screening.
  8. Uncontrolled or untreated hypertension at screening.
  9. Participants who have received medications that may affect endpoint assessment, such as other urate-lowering therapies, mRNA-LNP vaccine, PEGylated drugs and uricase agents.
  10. History of severe allergy, or known allergy to IN026 or its components.
  11. Participation in other clinical trials within 30 days prior to screening.
  12. Participants with poor compliance, or those deemed otherwise unsuitable for this study by the investigator.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: IN026 at Dose-Level A
Participants receive intravenous IN026 Injection at dose-level A on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Sperimentale: IN026 at Dose-Level B
Participants receive intravenous IN026 Injection at dose-level B on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Sperimentale: IN026 at Dose-Level C
Participants receive intravenous IN026 Injection at dose-level C on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Sperimentale: IN026 at Dose-Level D
Participants receive intravenous IN026 Injection at dose-level D on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Sperimentale: IN026 at Dose-Level E
Participants receive intravenous IN026 Injection at dose-level E on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Sperimentale: IN026 at Dose-Level F
Participants receive intravenous IN026 Injection at dose-level F on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Lasso di tempo: From first dose (Week 1 Day 1) through end of study (Week 21)
From first dose (Week 1 Day 1) through end of study (Week 21)

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Change from Baseline in Serum Uric Acid Concentration
Lasso di tempo: From baseline (Week 1 Day 1) through Week 21
From baseline (Week 1 Day 1) through Week 21
Change in Tophi from Baseline
Lasso di tempo: From baseline (Week 1 Day 1) through Week 21
From baseline (Week 1 Day 1) through Week 21
Plasma Concentration of IN026 mRNA Over Time
Lasso di tempo: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Plasma Concentration of Ionizable Lipid SX-66 Over Time
Lasso di tempo: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Uricase Level Over Time
Lasso di tempo: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Uric Acid Level Over Time
Lasso di tempo: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Allantoin Level Over Time
Lasso di tempo: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Titer of Anti-Drug Antibodies (ADAs) Over Time
Lasso di tempo: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: QiuBai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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