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- Ensaio Clínico NCT01858935
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Escalating Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ND-L02-s0201 Injection in Normal Healthy Subjects
9 de maio de 2017 atualizado por: Bristol-Myers Squibb
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ND-L02-s0201 Injection, a Vitamin A-Coupled Lipid Nanoparticle Containing siRNA Against HSP47, in Healthy Normal Subjects
This study is to evaluate the safety, tolerability, and pharmacokinetics of ND-L02-s0201 in normal, healthy, subjects
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
56
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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Kansas
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Overland Park, Kansas, Estados Unidos, 66211
- Quintiles Phase One Services, LLC
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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
18 anos a 55 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
- Male subjects aged between 18 and 55 years.
- Willing and able to comply with the study procedures and visit schedule, including follow-up visits.
- Able to communicate effectively with the study site personnel.
- Body mass index (BMI) within the range of ≥18.5 and ≤30.
Determined by the Investigator to be in good health as documented by the following:
- Medical history;
- Physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems);
- Vital sign assessments: systolic blood pressure ≤140 mmHg, diastolic blood pressure ≤90 mmHg, heart rate 45-85 bpm;
- Normal 12-lead electrocardiogram (ECG): heart rate: 44-85 bpm, PR interval: ≤210 msec, QRS duration: ≤120 msec, QTcF: ≤430 msec;
- Clinical laboratory assessments within the laboratory's limits of normal values or not considered clinically significant by the Investigator; and
- By general observations. For any abnormalities or deviations outside the normal ranges for any clinical tests (including all laboratory tests, ECG, vital signs), the test may be repeated at the discretion of the Investigator, but the results must be discussed with the Sponsor's Medical Monitor before being judged to be not clinically significant for study participation.
- Serum calcium, parathyroid hormone, testosterone within the laboratory's limits of normal values and 25OH-vitamin D ≥18 ng/mL.
- Non-smoker, defined as no smoking within the 3 months prior to administration of study drug and urine cotinine < 400 ng/mL.
- Consumed an average of no more than 2 drinks per day within the 6 months prior to administration of study drug. A drink is one 12 oz. beer, 4 oz. of wine, 1.5 oz. of 80-proof spirits, or 1 oz. of 100-proof spirits.
- Subjects with female partners of childbearing potential must agree to use an effective barrier method of contraception (e.g., condom with spermicide) from study drug administration until the Day 28 visit. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
- Subjects must give written informed consent.
Exclusion Criteria:
- Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of ND-L02-s0201, or would place the subject at increased risk.
- History of bone disease, including osteoporosis and osteomalacia, Paget's disease of bone, or a history of unexplained fractures or fractures after minimal trauma.
- The presence of abnormal laboratory values considered to be clinically significant by the Investigator.
- Positive screen for Hepatitis B (HBsAg, Hepatitis B Surface Antigen), Hepatitis C (anti-HCV, Hepatitis C Antibody) or human immunodeficiency virus (HIV) (anti-HIV 1/2).
- Participating in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug.
- Received any drug therapy (including prescription and over-the-counter drugs and herbal supplements) within 1 week or 5 half-lives (whichever is longer), prior to administration of study drug. Use of non-steroidal anti-inflammatory drugs (NSAIDs), sulfonamides, probenecid or other drugs known to alter renal or tubular function is specifically prohibited for at least 5 half-lives prior to the administration of study drug. Use of immuno-suppressants is specifically prohibited within 1 week or 5 half-lives (whichever is longer), prior to administration of study drug. Vitamin A containing multi-vitamins must be withheld from Day -1 through Day 5.
- Consumption of alcohol within 48 hours prior to administration of study drug or during the in-patient period.
- Positive urine screen for drugs of abuse, to include ethanol, cocaine, tetrahydrocannabinol (THC), barbiturates, amphetamines, benzodiazepines, opiates, cotinine, and other drugs of abuse in the study site's location.
- History, within the last 2 years, of alcohol abuse, significant mental illness, or physical dependence on any opioid.
- Illicit drug use within the last 90 days.
- Demonstration, in the opinion of study staff, of veins unsuitable for repeated venipuncture or intravenous infusion (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
- Recent treatment with alternative therapies, which, in the opinion of the Investigator, could potentially confound clinical or laboratory assessments.
- Donation or loss of more than 500 mL of blood within 56 days prior to administration of study drug or donation of plasma within 7 days prior to administration of study drug.
- History of malignancy within the last 5 years, with the exception of non-facial basal cell carcinoma.
- History of severe allergic or anaphylactic reactions.
- Any other reason that, in the opinion of the Investigator or the Sponsor's Medical Monitor, makes the subject unsuitable for enrollment.
- History of hypersensitivity to H2-receptor antagonists.
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: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador de Placebo: Placebo
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Single IV infusion.
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Experimental: ND-L02-s0201 Injection 0.03 mg/kg
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Single IV infusion.
Outros nomes:
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Experimental: ND-L02-s0201 Injection 0.1 mg/kg
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Single IV infusion.
Outros nomes:
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Experimental: ND-L02-s0201 Injection 0.2 mg/kg
|
Single IV infusion.
Outros nomes:
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Experimental: ND-L02-s0201 Injection 0.4 mg/kg
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Single IV infusion.
Outros nomes:
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Experimental: ND-L02-s0201 Injection 0.5 mg/kg
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Single IV infusion.
Outros nomes:
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Experimental: ND-L02-s0201 Injection 0.6 mg/kg
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Single IV infusion.
Outros nomes:
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Experimental: ND-L02-s0201 Injection 0.8 mg/kg
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Single IV infusion.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Incidence, nature, and severity of adverse events and abnormal clinical laboratory tests
Prazo: After single-ascending doses
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After single-ascending doses
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Pharmacokinetic profile and parameters
Prazo: After single-ascending doses
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After single-ascending doses
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David Mathews, MD, Quintiles Phase One Services, LLC
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
1 de maio de 2013
Conclusão Primária (Real)
1 de fevereiro de 2014
Conclusão do estudo (Real)
1 de fevereiro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
17 de maio de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de maio de 2013
Primeira postagem (Estimativa)
21 de maio de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de maio de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de maio de 2017
Última verificação
1 de maio de 2017
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- ND-L02-s0201-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 .
Ensaios clínicos em ND-L02-s0201 Injection
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Bristol-Myers SquibbNitto Denko CorporationConcluído
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Nitto Denko CorporationConcluídoFibrose Pulmonar IdiopáticaEstados Unidos, Alemanha, Japão, Reino Unido
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Bristol-Myers SquibbNitto Denko CorporationConcluídoFibrose hepática moderada a extensa (METAVIR F3-4)Bulgária, Estados Unidos