To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Single and Multiple Doses of TUL321 Capsule in Healthy Participants, and the Effect of Food on Pharmacokinetics
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Primary Objective:
To evaluate the safety and tolerability following single and multiple oral dministrations of TUL321 capsules in healthy participants.
Secondary Objectives:
- To characterize the pharmacokinetic (PK) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
- To evaluate the effect of a high-fat meal on the PK profiles after a single oral administration of TUL321 capsules in healthy participants;
- To preliminarily assess the in vivo biotransformation and mass balance characteristics following single oral administration of TUL321 capsules;
- To characterize the pharmacodynamic (PD) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
- To evaluate the effect of single oral administration of TUL321 capsules on the QT/QTc interval.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Guoping Yang
- Número de telefone: +86-13974817168
- E-mail: ygp9880@163.com
Locais de estudo
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Hunan
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Changsha, Hunan, China
- Recrutamento
- Third Xiangya Hospital of Central South University
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Contato:
- Guoping Yang
- Número de telefone: +86-13974817168
- E-mail: ygp9880@163.com
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Participants can communicate well with investigators, fully understand the study, volunteer to take part, comply with all study requirements, and sign written informed consent before study procedures.
- Age 18-45 years (inclusive) at informed consent, male or female.
- Weight ≥50.0 kg for males, ≥45.0 kg for females; BMI 19.0-26.0 kg/m² (inclusive).
- Female participants with child-bearing potential, and male participants whose partners have child-bearing potential: no pregnancy, sperm or egg donation from consent to 3 months after last dose, and willing to use study-required contraception.
- For MAD-only participants: receive ACYW135 meningococcal vaccine and pneumococcal vaccine at least 14 days before first dose. No re-vaccination is needed if pneumococcal vaccine was given within 5 years, or ACYW135 meningococcal vaccine within 3 years prior to first dose.
Exclusion Criteria:
- Suspected or confirmed allergy to investigational product or its similar components; or history of multiple drug/food allergies.
- Past history of tuberculosis infection or active tuberculosis at screening.
- Known or suspected history of immunodeficiency, inherited or acquired complement deficiency.
- Confirmed active systemic bacterial, viral or fungal infection within 2 weeks before screening.
- History of confirmed encapsulated bacterial infection within 6 months before screening, including but not limited to meningococcus, streptococcus pneumoniae, Haemophilus influenzae type b.
- Clinically significant abnormal findings in laboratory tests, physical examination, vital signs, ECG, chest X-ray or abdominal ultrasound at screening.
- QTcF (Fridericia correction) ≥450 ms at screening; or other risk factors for torsades de pointes (TdP), such as heart failure, hypokalemia, hypomagnesemia, family history of long QT syndrome.
- eGFR <90 mL/min/1.73 m² (calculated by CKD-EPI formula) at screening.
- Positive for HBsAg, anti-HCV, anti-HIV or syphilis-specific antibody at screening.
- Received other vaccines not specified in the protocol within 1 month before screening, or plan to receive such vaccines during the study.
- Participated in another interventional clinical trial within 3 months before screening (excluding subjects who only completed screening without enrollment, or enrolled but did not receive study treatment).
- Average daily cigarette consumption >5 cigarettes within 3 months before screening.
- History of drug/substance abuse within 6 months before screening, or positive drug abuse screening test.
- Chronic constipation or diarrhea, or other conditions judged by investigator to interfere with fecal sample collection.
- Required or plan to perform heavy physical labor or strenuous exercise during study participation.
- Pregnant or lactating women, or women of child-bearing potential with positive pregnancy test at screening.
- Acute illness or concomitant medication occurs from screening to pre-first-dose.
- Cannot tolerate high-fat meal (applies only to subjects in the food-effect sub-study).
- Difficulty swallowing, intolerance to venipuncture, or history of needle-syncope or blood-syncope.
- Investigator judges that the subject is unsuitable for this study for any other reason.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Quadruplicar
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: TUL321
Healthy participants take oral TUL321 capsules: Part1 single ascending doses, Part2 multiple daily doses to assess safety, tolerability, PK, PD and food effect.
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orally, 20 mg、50 mg、 100 mg、200 mg、400 mg and 600 mg
Outros nomes:
orally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID
Outros nomes:
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Comparador de Placebo: Placebo
Healthy participants receive oral placebo capsules matching TUL321 capsules in Part 1 and Part 2, administered in parallel with TUL321 treatment cohorts as control.
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Oral placebo capsules matching TUL321 capsules
Outros nomes:
Oral placebo capsules matching TUL321 capsules
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests
Prazo: up to 17 days
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up to 17 days
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Peak plasma concentration (Cmax)
Prazo: Pre-dose to 144 hours post-dose
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Pre-dose to 144 hours post-dose
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Time to maximum plasma concentration (Tmax)
Prazo: Pre-dose to 144 hours post-dose
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Pre-dose to 144 hours post-dose
|
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Cumulative amount excreted(Ae)in urine
Prazo: Pre-dose to 144 hours post-dose
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Pre-dose to 144 hours post-dose
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Cumulative amount excreted(Ae)in feces
Prazo: Pre-dose to 144 hours post-dose
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Pre-dose to 144 hours post-dose
|
|
Alternative pathway (AP) activity
Prazo: Pre-dose to 144 hours post-dose
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Pre-dose to 144 hours post-dose
|
|
Bb concentration
Prazo: Pre-dose to 144 hours post-dose
|
Pre-dose to 144 hours post-dose
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Guoping Yang, The Third XIANGYA Hospital of Central South University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- TUL-TUL321(I-2)202605
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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