- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07587684
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
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
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
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Can voluntarily sign the informed consent form (ICF) and comply with ICF and study protocol requirements.
- Male or female, 18-75 years old (inclusive) at screening.
- Meet 2015 ACR/EULAR gout classification criteria, in the intercritical phase of gout or acute flare resolved ≥2 weeks at screening.
- Serum uric acid ≥420 μmol/L (7 mg/dl) at screening.
- Meet the definition of refractory gout (poor uric acid control accompanied by severe gout symptoms)
Exclusion Criteria:
- Gout secondary to radiotherapy/chemotherapy, lead poisoning, organ transplantation, tumor, etc. at screening/baseline.
- Rheumatoid arthritis, infectious/septic arthritis, or other acute inflammatory arthritis at screening/baseline.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency history, or G6PD level below normal lower limit.
- Positive HBsAg; HCV antibody positive is excluded except those with sustained HCV-RNA negativity after standard treatment; HIV antibody positive; active syphilis.
- Presence of chronic liver diseases including active hepatitis, cirrhosis and alcoholic liver disease.
- 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.
- Prolonged QTcF at screening.
- Uncontrolled or untreated hypertension at screening.
- Participants who have received medications that may affect endpoint assessment, such as other urate-lowering therapies, mRNA-LNP vaccine, PEGylated drugs and uricase agents.
- History of severe allergy, or known allergy to IN026 or its components.
- Participation in other clinical trials within 30 days prior to screening.
- Participants with poor compliance, or those deemed otherwise unsuitable for this study by the investigator.
Piano di studio
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
Investigatori
- Investigatore principale: QiuBai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Artropatie cristalline
- Malattie muscoloscheletriche
- Processi patologici
- Artrite
- Malattie articolari
- Metabolismo delle purine-pirimidine, errori congeniti
- Metabolismo, errori congeniti
- Malattie genetiche, congenite
- Malattie del tessuto connettivo
- Malattie e anomalie congenite, ereditarie e neonatali
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Malattie della pelle e del tessuto connettivo
- Gotta
- Iperuricemia
- Malattie metaboliche
- Malattie reumatiche
Altri numeri di identificazione dello studio
- IN026-001
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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 .
Prove cliniche su IN026 Injection
-
Shanghai JMT-Bio Inc.ReclutamentoCarcinoma epatocellulare | Tumore solido avanzato | Carcinoma polmonare a cellule squamoseCina
-
Jiangsu HengRui Medicine Co., Ltd.Reclutamento
-
Changhai HospitalNon ancora reclutamentoLinfoma a cellule B recidivato o refrattario
-
Beijing Tiantan HospitalNon ancora reclutamentoIctus ischemico acuto
-
Suzhou Mednovo Yi Medical Technology Co., Ltd.ReclutamentoEpatoma | Carcinoma epatocellulare non resecabile (HCC)Cina
-
Bio-Thera SolutionsCompletato
-
Shanghai Junshi Bioscience Co., Ltd.CompletatoCarcinoma polmonare non a piccole cellule avanzato naïve al trattamentoCina
-
Eye & ENT Hospital of Fudan UniversityChanghai Hospital; Shanghai Zhongshan Hospital; Fujian Medical University Union... e altri collaboratoriReclutamentoCarcinoma rinofaringeo ricorrenteCina
-
Beijing Biostar Pharmaceuticals Co., Ltd.Reclutamento
-
Taihe HospitalNon ancora reclutamento