- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: QiuBai Li Union Hospital, Tongji Medical College, Huazhong University of
- Numéro de téléphone: +86-27-85726338
- E-mail: qiubaili@hust.edu.cn
Lieux d'étude
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Wuhan, Chine
- Recrutement
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contact:
- Huazhong University of Science and Technology Union Hospital, Tongji Medical College,
- Numéro de téléphone: 027-85726685
- E-mail: whuniongcp01@126.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Délai: From first dose (Week 1 Day 1) through end of study (Week 21)
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From first dose (Week 1 Day 1) through end of study (Week 21)
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Change from Baseline in Serum Uric Acid Concentration
Délai: From baseline (Week 1 Day 1) through Week 21
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From baseline (Week 1 Day 1) through Week 21
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Change in Tophi from Baseline
Délai: From baseline (Week 1 Day 1) through Week 21
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From baseline (Week 1 Day 1) through Week 21
|
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Plasma Concentration of IN026 mRNA Over Time
Délai: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
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At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
|
|
Plasma Concentration of Ionizable Lipid SX-66 Over Time
Délai: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
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At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
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Serum Uricase Level Over Time
Délai: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
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At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
|
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Serum Uric Acid Level Over Time
Délai: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
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At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
|
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Serum Allantoin Level Over Time
Délai: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
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At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
|
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Titer of Anti-Drug Antibodies (ADAs) Over Time
Délai: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
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At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: QiuBai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Arthropathies cristallines
- Maladies musculo-squelettiques
- Processus pathologiques
- Arthrite
- Maladies articulaires
- Métabolisme de la purine-pyrimidine, erreurs innées
- Métabolisme, erreurs innées
- Maladies génétiques, innées
- Maladies du tissu conjonctif
- Maladies et anomalies congénitales, héréditaires et néonatales
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Maladies de la peau et du tissu conjonctif
- Goutte
- Hyperuricémie
- Maladies métaboliques
- Maladies rhumatismales
Autres numéros d'identification d'étude
- IN026-001
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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