A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
23 de junho de 2026 atualizado por: Shanghai Argo Biopharmaceutical Co., Ltd.
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
Tipo de estudo
Intervencional
Inscrição (Estimado)
24
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
-
-
-
Shanghai, China
- Argo Investigative Site
-
-
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:
- Capable of providing written informed consent and complying with all study procedures for the duration of the study.
- Body weight > 50 kg for males and > 45 kg for females; body mass index (BMI) within a range considered appropriate for study participation by the investigator.
- Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
- Male participants with partners of childbearing potential must agree to use effective contraception.
Exclusion Criteria:
- Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study.
- Recent hospitalization or a significant acute medical event.
- History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
- Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
- Positive test for hepatitis B, hepatitis C, or HIV.
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: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Placebo Salino
Dose única de Placebo Salino
|
Solução para injeção
|
|
Experimental: BW-50218 Dose1
Single dose of BW-50218 injection (Dose 1)
|
Solução para injeção
|
|
Experimental: BW-50218 Dose 2
Single dose of BW-50218 injection (Dose 2)
|
Solução para injeção
|
|
Experimental: BW-50218 Dose 3
Single dose of BW-50218 injection (Dose 3)
|
Solução para injeção
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)
Prazo: From baseline up to Day 360 (End of Study)
|
Evaluation of the number of participants with treatment-emergent adverse events and serious adverse events.
The severity of AEs will be assessed and categorized according to the "Guidance for industry: Toxicity Grading Scale for Healthy Adultand Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA, 2007).
|
From baseline up to Day 360 (End of Study)
|
|
Hematology results (Platelets, 10^9/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
Prazo: From baseline up to Day 360 (End of Study)
|
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
|
From baseline up to Day 360 (End of Study)
|
|
Hematology results (concentration of Hemoglobin, g/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
Prazo: From baseline up to Day 360 (End of Study)
|
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
|
From baseline up to Day 360 (End of Study)
|
|
Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
Prazo: From baseline up to Day 360 (End of Study)
|
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
|
From baseline up to Day 360 (End of Study)
|
|
Chemistry results (Alkaline Phosphatase, U/L; Alanine Aminotransferase, U/L; Aspartate Aminotransferase, U/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
Prazo: From baseline up to Day 360 (End of Study)
|
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
|
From baseline up to Day 360 (End of Study)
|
|
Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
Prazo: From baseline up to Day 360 (End of Study)
|
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
|
From baseline up to Day 360 (End of Study)
|
|
Urinalysis results (Epithelial cells, crystals, casts, bilirubin) at each time point,including change from baseline to Day 360 post dose will be summarized in thetable by treatment group.
Prazo: From baseline up to Day 360 (End of Study)
|
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be fagged.
|
From baseline up to Day 360 (End of Study)
|
|
Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group
Prazo: From baseline up to Day 360 (End of Study)
|
Abnormal physical examination findings will be listed.
|
From baseline up to Day 360 (End of Study)
|
|
Vital signs (Heart rate, beats per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Prazo: From baseline up to Day 360 (End of Study)
|
Abnormal physical examination findings will be listed.
|
From baseline up to Day 360 (End of Study)
|
|
Vital signs (Respiratory rate, times per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Prazo: From baseline up to Day 360 (End of Study)
|
Abnormal physical examination findings will be listed.
|
From baseline up to Day 360 (End of Study)
|
|
Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Prazo: From baseline up to Day 360 (End of Study)
|
Abnormal physical examination findings will be listed.
|
From baseline up to Day 360 (End of Study)
|
|
Changes in ECG (PR Interval, msec; QRs Duration, msec;QT interval, msec; RR interval, msec; QTcF Interval, msec; ) from Baseline to Day 360 post-dose will be summarized.
Prazo: From baseline up to Day 360 (End of Study)
|
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point.
Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
|
From baseline up to Day 360 (End of Study)
|
|
Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 post-dose will be summarized.
Prazo: From baseline up to Day 360 (End of Study)
|
12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point.
Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
|
From baseline up to Day 360 (End of Study)
|
|
Change from Baseline in Physical Examination Findings
Prazo: From baseline up to Day 360 (End of Study)
|
Assessment of clinically significant changes in physical examination findings
|
From baseline up to Day 360 (End of Study)
|
|
Hematology results (Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
Prazo: From baseline up to Day 360 (End of Study)
|
The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
|
From baseline up to Day 360 (End of Study)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Concentração Plasmática Máxima Observada (Cmax)
Prazo: Desde antes da dose até ao Dia 8
|
Avaliação da concentração plasmática máxima de BW-50218.
|
Desde antes da dose até ao Dia 8
|
|
Tempo até a Concentração Plasmática Máxima (Tmax)
Prazo: Desde antes da administração até ao Dia 8
|
Avaliação do tempo para atingir a concentração plasmática máxima.
|
Desde antes da administração até ao Dia 8
|
|
Area Under the Plasma Concentration-Time Curve (AUC)
Prazo: From pre-dose up to Day 8
|
Evaluation of AUc from time zero to 24 hours (AUC0-24), to 48 hours (AUC0-48), and to infinity (AUC0-inf)
|
From pre-dose up to Day 8
|
|
Terminal Elimination Half-Life (t1/2)
Prazo: From pre-dose up to Day 8
|
Evaluation of the elimination half-life of BW-50218
|
From pre-dose up to Day 8
|
|
Urine Pharmacokinetic Parameters (Renal Clearance, CLr)
Prazo: From pre-dose up to 24 hours post-dose
|
Renal clearance calculated as CLr = CAe/Plasma AUC 0-24.
Ae=cumulative amount excreted in urine (mg).
AUC 0-24 = Area under the plasma concentration - time curve from 0 to 24 hours(e.g.mg*h/mL)
|
From pre-dose up to 24 hours post-dose
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Yuqiong Li, Shanghai Argo Biopharmaceutical Co., Ltd.
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)
18 de maio de 2026
Conclusão Primária (Estimado)
30 de junho de 2027
Conclusão do estudo (Estimado)
30 de abril de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
13 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de maio de 2026
Primeira postagem (Real)
11 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BW-50218-1002
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
A decision regarding sharing of de-identified IPD will be made by the Sponsor after study completion and will consider scientific merit, participant privacy, and regulatory requirements.
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 .