A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101) (INT-210-I101)
27 de maio de 2026 atualizado por: Innatus Therapeutics (Shanghai) Co., Ltd.
A Phase I, Single and Multiple Ascending Dose Escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Subjects
A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers.
Primary Objectives:
● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers,
Secondary Objectives:
- To assess the pharmacokinetic(PK) profile of single and multiple oral doses of INT-210 capsules in healthy adult voluteers;
- To assess the safety and tolerability of INT-210 capsulese administered under fasting and fed(high-fat-meal) conditions in healthy adult voluteers;
- To assess the effect of food on the PK profile of a single oral dose of INT-210 capsules in healthy adult voluteers;
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
86
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Beijing, China
- Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Male or female healthy voluteers
- Aged 18-45 years(inclusive),
- In good general health with no evidence of active or chronic disease; and who agree to comply with the prescribed contraceptive requirement during the trial and for 3 months after the last dose.
Exclusion Criteria:
- Female who are pregnant or breastfeeding; or planing pregnancy, female of chidbearing potential not using adequate contraception.
- Pre-existing significant medical conditions(cardiac, hepatic, renal, gastrointestina, etc), abnormal lab results, active infection, or history of special conditions like long QT syndrome or hypocalcemia.
- Positive screening for HIV, Hepatitis B/C or syphilis;
- Recent subject in another clinical trial;
- Recent major surgery, or significant blood loss.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Single Ascending Dose from 50 mg to 800 mg
Single Ascending Dose
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400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
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Experimental: Food Effect: 400mg
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400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
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Experimental: Multiple Ascending Dose: 200 mg to 600mg
BID
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400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
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Comparador de Placebo: Placebo
Placebo for SAD, MAD and Food Effect
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INT-210 Placebo BID
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The incidence of treatment-emergent adverse events
Prazo: From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Number of participants with treatment-related adverse events as assessed.
The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment.
The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity.
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From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology
Prazo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
Prazo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
Prazo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, Lactate dehydrogenase (LDH)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis
Prazo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Specific gravity, PH, Glucose, Protein, Nitrite , Urobilinogen, Occult Blood, White blood cells, Ketones, Red blood cells
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
Prazo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
Prazo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
Prazo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM)
Prazo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: hemoglobin saturation (%)
Prazo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃)
Prazo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pharmacokinetics parameter: Cmax of INT-210
Prazo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Maximum observed plasma concentration (ng/mL)
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: Tmax of INT-210
Prazo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Time of maximum observed concentration (Tmax) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: AUC (0-T) of INT-210
Prazo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Area Under the concentration-time curve from dosing to the time of the last measured concentration (AUC0-T) (h*ng/L) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: T1/2 of INT-210
Prazo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Half-life (T1/2) (hours) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: CL/F of INT-210
Prazo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Apparent clearance (L/h) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: Vz/F of INT-210
Prazo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Apparent volume of distribution (L) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: AUCinf of INT-210
Prazo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Area under the curve from time 0 extrapolated to infinite time (AUCinf) (h*ng/L) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Potential risk of QT/QTc interval prolongation of INT-210
Prazo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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A correlation model will be constructed using drug concentrations and ECG parameters to analyze the concentration-QTc relationship, and the potential risk of QT/QTc interval prolongation will be assessed by establishing a "concentration-effect model".
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Fraction excreted: Fraction of drug excreted unchanged in urine and Feces
Prazo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Fraction of dose excreted unchanged into urine and feces as a percentage (%)
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
4 de setembro de 2025
Conclusão Primária (Real)
6 de janeiro de 2026
Conclusão do estudo (Real)
6 de janeiro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
24 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de maio de 2026
Primeira postagem (Real)
1 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- INT-210-I101
- CTR20253467 (Outro identificador: National Medical Products Administration (NMPA))
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .