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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05027373
Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection
27 de agosto de 2021 atualizado por: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
A Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects
This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody injection in Healthy Subjects.
Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
This study is a randomized, double-blind, placebo-controlled parallel trial of safety, tolerability and pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody by single subcutaneous injection with five different doses in healthy subjects.
There are 5 groups as follows: 0.03mg/kg (S1), 1.0mg/kg (S2), 3.0mg/kg (S3), 6.0mg/kg (S4) and 10.0mg/kg (S5); and 2 subjects were included in the S1 group (both received study drugs); 8 subjects were included in each of the S2 ~ S5 groups (of which 6 received study drugs and 2 received placebo).
In each group, two subjects were sentinels (1 received the study drug and 1 placebo).
Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
34
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.
Contato de estudo
- Nome: Qian Chen, PhD
- Número de telefone: 02154030254
- E-mail: qchen@shxh-centerlab.com
Locais de estudo
-
-
Shanghai
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Shanghai, Shanghai, China, 201203
- Recrutamento
- Shanghai Xuhui District Central Hospital
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Contato:
- Chuan Lu
-
-
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
18 anos a 45 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
- The body mass index (BMI) is in the range of 19.0~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
- Male participants and their partners or female participants must agree to take one or more non-drug contraceptives (such as complete abstinence, contraceptive rings, partner ligation, etc.) , and there is no sperm donation or egg donation plan until 3 months after finished the study
- Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent
- Participants could communicate well with the researchers and compliance with the trial
Exclusion Criteria:
- Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
- Subjects who have or are currently suffering from any serious clinical diseases 3-6 months before screening, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities or any other that can interfere with the study results
- Clinical laboratory examinations (blood routine, urine routine, blood biochemistry, coagulation function, etc.), auxiliary examinations (chest X-ray, abdominal ultrasound) found to be abnormal and have clinical significance
- Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
- Alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), or those who have a positive alcohol breath test (screening period or baseline period) or couldn't prohibit alcohol during the trial
- Those who smoked more than 5 cigarettes per day during the 3 months before screening, or have a positive urine nicotine screening test (screening period or baseline period)
- Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening (morphine, Ketamine, tetrahydrocannabinol acid, methamphetamine , dimethyldioxyamphetamine, cocaine)
- Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 14 days before administration
- Has received any monoclonal antibody drugs within 3 months before administration
- Has a history of vaccination within 3 months before dosing, or intend to receive vaccines during the study
- Was previously enrolled in other clinical trials within 3 months before dosing
- Blood donors or subjects who lost a lot of blood (> 400 mL, except for women's physiological period) or those who received blood transfusion or used blood products within 3 months
- Can't tolerate venipuncture or has a history of halo needles and halo blood
- Has known or suspected pregnancy or lactation
- Abnormal vital signs (SBP <90 mmHg or ≥140 mmHg, DBP <55 mmHg or ≥90 mmHg; heart rate <50 bpm or> 100 bpm; body temperature <35.4℃ or > 37.3℃) or abnormal ECG (QTcF ≥450 ms) or physical examination are clinically significant (according to the judgment of clinical research doctors)
Those who are infected and need to be treated for acute or chronic infections, as follows:
- Suffering from herpes zoster within 12 months before screening;
- Currently in any inhibitory treatment for chronic infections (eg, tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster virus, and atypical mycobacteria);
- A history of tuberculosis or contact with patients with open tuberculosis in the past 6 months,or a T-spoT-positive results;
- Infected with parasites within 3 months before administration;
- Hospitalized for infectious diseases within 30 days before administration;
- Received anti-infective drugs (including antibacterial, antiviral, antifungal, or antiparasitic drugs) by parenteral administration (iv or im) 30 days before administration
- Subjects who are unsuited to the study for any reason, judged by the investigators
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
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Placebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless.
|
Experimental: SSGJ-613
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SSGJ-613 injection is 200mg/2mL solution in a single vial.The solution is a clear to slightly opalescent, colorless to a slightly yellow tint.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Cmax
Prazo: up to 112 days
|
up to 112 days
|
Tmax
Prazo: up to 112 days
|
up to 112 days
|
AUC0-t
Prazo: up to 112 days
|
up to 112 days
|
t1/2
Prazo: up to 112 days
|
up to 112 days
|
CL/F
Prazo: up to 112 days
|
up to 112 days
|
Vd/F
Prazo: up to 112 days
|
up to 112 days
|
Ke
Prazo: up to 112 days
|
up to 112 days
|
AUC0-∞
Prazo: up to 112 days
|
up to 112 days
|
AE
Prazo: up to 112 days
|
up to 112 days
|
SAE
Prazo: up to 112 days
|
up to 112 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
total IL-1β
Prazo: up to 112 days
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up to 112 days
|
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free IL-1β
Prazo: up to 112 days
|
up to 112 days
|
|
ADA
Prazo: up to 112 days
|
Bridging method will be used to detect the incidence and titer for ADA through one three-step detection strategy, that is preliminary screening, confirmation and titer
|
up to 112 days
|
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)
13 de agosto de 2021
Conclusão Primária (Antecipado)
30 de abril de 2022
Conclusão do estudo (Antecipado)
30 de setembro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
17 de agosto de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de agosto de 2021
Primeira postagem (Real)
30 de agosto de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de agosto de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de agosto de 2021
Última verificação
1 de agosto de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SSGJ-613-HH-I-01
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 .
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