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A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects

13 de fevereiro de 2022 atualizado por: Ark Biosciences Inc.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Up to 3 dose cohorts are planned. The ziresovir dose level of each cohort is determined based on the collective clinical and nonclinical data of ziresovir.

The proposed dose levels of Cohorts 1, 2 and 3 are 300 mg and up to 600 mg and up to 900 mg, respectively.

A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6 subjects to receive placebo in a double-blind fashion. Eight subjects will be randomized in each dose cohort, with 6 subjects to receive active drug and 2 subjects o receive placebo.

Tipo de estudo

Intervencional

Inscrição (Real)

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

  • Estados Unidos
    • New Jersey
      • Secaucus, New Jersey, Estados Unidos, 07094
        • Frontage

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

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Capable of giving written informed consent and complying with study procedures;
  2. Between the ages of 18 and 55 years, inclusive;
  3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
  4. Female subjects must have a negative pregnancy test result at screening;
  5. Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;
  6. Willing and being able to adhere to study restrictions and to be confined at the Clinical Research Unit.

Exclusion Criteria:

  1. Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
  2. Poor venous access;
  3. Taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer;
  4. Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the study drug dose;
  5. Major surgery or hospitalization within 6 months prior to screening that in the Investigator's opinion would put the subject or study conduct at risk, or have any scheduled surgery or hospitalization during the study period;
  6. Any condition or finding that in the Investigator's opinion would put the subject or study conduct at risk if the subject were to participate in the study.

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: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: ziresovir

The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast.

Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:

  • If administered 60 mL as the study drug dose, follow with approximately 180 mL water.
  • If administered 120 mL as the study drug dose, follow with approximately 120 mL water.
  • If administered 180 mL as the study drug dose, follow with approximately 60 mL water.
Medicamento: Ziresovir

Planned treatments are:

  • Cohort 1: 300 mg of ziresovir
  • Cohort 2: up to 600 mg of ziresovir
  • Cohort 3: up to 900 mg of ziresovir
Outros nomes:
  • AK0529
Comparador de Placebo: placebo

The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast.

Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:

  • If administered 60 mL as the study drug dose, follow with approximately 180 mL water.
  • If administered 120 mL as the study drug dose, follow with approximately 120 mL water.
  • If administered 180 mL as the study drug dose, follow with approximately 60 mL water.
Outro: Placebo

Planned treatments are:

  • Cohort 1: 300 mg of placebo
  • Cohort 2: up to 600 mg of placebo
  • Cohort 3: up to 900 mg of placebo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
numbers of all AEs
Prazo: through study completion, an average of 22 days
The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
through study completion, an average of 22 days
percentages of all AEs
Prazo: through study completion, an average of 22 days
The Common Terminology Criteria for Adverse Events (CTCAE) Version 5 will be used to grade AEs
through study completion, an average of 22 days
change from baseline in systolic and diastolic blood pressure
Prazo: screen/day -1/day 1/day 2/day 3/day4
blood pressure in millimeter of mercury
screen/day -1/day 1/day 2/day 3/day4
change from baseline in pulse rate
Prazo: screen/day -1/day 1/day 2/day 3/day4
pulse rate in times per minute
screen/day -1/day 1/day 2/day 3/day4
change from baseline in respiratory rate
Prazo: screen/day -1/day 1/day 2/day 3/day4
respiratory rate in times per minute
screen/day -1/day 1/day 2/day 3/day4
change from baseline in oral temperature
Prazo: screen/day -1/day 1/day 2/day 3/day4
oral temperature in degree
screen/day -1/day 1/day 2/day 3/day4
change from baseline in Prothrombin time/International Normalized Ratio
Prazo: screen/day -1/day 2/day4
INR is calculated from the PT and allows for worldwide standardization of results.
screen/day -1/day 2/day4
change from baseline in Thrombin time
Prazo: screen/day -1/day 2/day4
Thrombin time in seconds
screen/day -1/day 2/day4
change from baseline in activated Partial Thromboplastin time
Prazo: screen/day -1/day 2/day4
activated Partial Thromboplastin time in seconds
screen/day -1/day 2/day4
change from baseline in Hemoglobin (Hgb) count
Prazo: screen/day -1/day 2/day4
Hemoglobin (Hgb) in gram per liter
screen/day -1/day 2/day4
change from baseline in Hematocrit (Hct)
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Platelet count
Prazo: screen/day -1/day 2/day4
Platelet count per liter
screen/day -1/day 2/day4
change from baseline in Red blood cell (RBC) count
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in White blood cell (WBC) count with differential
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Specific gravity from urinalysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in pH from urinalysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Protein from urinalysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Glucose from urinalysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Ketones from urinalysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Bilirubin from urinalysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Blood from urinalysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Nitrites from urinalysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Leukocytes from urinalysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in Urobilinogen from urinalysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
Incidence of abnormal Microscopic urine analysis
Prazo: screen/day -1/day 2/day4
screen/day -1/day 2/day4
change from baseline in heart rate-corrected QT interval from resting 12-lead ECGs
Prazo: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
screen/day -1/day1/day2/day4
change from baseline in heart rate from resting 12-lead ECGs
Prazo: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
screen/day -1/day1/day2/day4
change from baseline in QRS intervals from resting 12-lead ECGs
Prazo: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
screen/day -1/day1/day2/day4
change from baseline in treatment-emergent T-wave morphology from resting 12-lead ECGs
Prazo: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
screen/day -1/day1/day2/day4
change from baseline in appearance of U-waves from resting 12-lead ECGs
Prazo: screen/day -1/day1/day2/day4
ECGs will be performed after the subject has been supine for at least 5 minutes
screen/day -1/day1/day2/day4
Incidence of abnormal physical findings
Prazo: screen/day -1/day2/day3/day4
full physical examination will be conducted at screening and an abbreviated physical exam will be conducted on Day -1 and Day 2. A symptom-directed physical exam will be conducted on Day 3 and Day 4.
screen/day -1/day2/day3/day4

Medidas de resultados secundários

Medida de resultado
Prazo
To characterize the drug concentration of ziresovir following single ascending doses by oral administration in healthy adult male and female subjects
Prazo: 0 (within 90 minutes prior to dosing) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose
0 (within 90 minutes prior to dosing) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ark Biosciences Inc.

Investigadores

  • Diretor de estudo: Jimmy Gu, Ark Biosciences

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)

24 de março de 2021

Conclusão Primária (Real)

14 de junho de 2021

Conclusão do estudo (Real)

22 de julho de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

1 de fevereiro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de março de 2021

Primeira postagem (Real)

9 de março de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de fevereiro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de fevereiro de 2022

Última verificação

1 de fevereiro de 2022

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • AK0529-3001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

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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