Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KR25102 in Healthy Volunteers

25 de maio de 2026 atualizado por: Jiangxi Kvvit Pharmaceutical Co., Ltd.

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single and Multiple Ascending Intravenous Doses of KR25102 for Injection in Healthy Adult Chinese Participants

Phase 1 Single Ascending Doses(SAD): Six cohorts of 53 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo.

Phase 1 Multiple Ascending Doses(MAD): Three cohorts of 30 HVs will receive multiple IV bolus injections of study drug or placebo every day. After 7 days of continuous administration, the safety, tolerance and Pharmacokinetic/Pharmacodynamic characteristics of multiple administrations were evaluated.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This study adopts a single-center, randomized, double-blind, placebo-controlled parallel-group, dose-escalation design.

This single ascending dose (SAD) study is designed with six dose cohorts: 5 mg, 10 mg, 20 mg, 30 mg, 45 mg, and 60 mg. A total of 53 healthy adult participants are planned to be enrolled.

Three participants are planned for the 5 mg cohort, randomized in a 2:1 ratio of investigational product to placebo. Each of the remaining five dose cohorts will enroll 10 participants, randomized in an 8:2 ratio of investigational product to placebo.

For the multiple ascending dose (MAD) part, three dose cohorts (10 mg, 20 mg, and 30 mg) are planned. A total of 30 healthy adult participants will be enrolled, with 10 participants per cohort randomized in an 8:2 ratio of investigational product to placebo.Subjects will receive once daily administration for 7 consecutive days according to the randomization scheme.

Tipo de estudo

Intervencional

Inscrição (Estimado)

83

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: Man Xu
  • Número de telefone: +86-19979703650
  • E-mail: xuman@kvvit.com

Locais de estudo

    • Hunan
      • Changsha, Hunan, China, 410006
        • The Third Xiangya Hospital, Central South University
        • Contato:

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:

  1. Male and female participants aged between 18 and 55 years inclusive (as of the time of signing the informed consent form);
  2. Male participants with body weight ≥ 50 kg and female participants with body weight ≥ 45 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m² (inclusive of boundary values);
  3. Participants and their partners have no plans for conception, sperm donation or oocyte donation from signing the informed consent form until 2 months after the last dose of study drug, and are willing to adopt highly effective contraceptive measures;
  4. Female participants: not pregnant or breastfeeding; female participants of child-bearing potential must have negative serum pregnancy test results at screening and baseline visits;
  5. For groups requiring pain testing: willing to undergo pain tests and pass training; with no wounds or skin diseases on the skin at the pain-stimulated site;
  6. Participants fully understand the purpose, requirements and potential risks of this trial, are willing to strictly comply with all trial requirements, voluntarily participate in the clinical trial and sign the written informed consent form.

Exclusion Criteria:

  1. Subjects with previous or current clinical acute or chronic diseases including but not limited to cardiovascular, endocrine-metabolic, neuropsychiatric, digestive, respiratory, hematopoietic-lymphoid, immune, urinary, musculoskeletal diseases and malignant tumors, who are judged unsuitable for enrollment by the investigator;
  2. Subjects with personal or family history of hereditary angioedema;
  3. Subjects who have undergone major surgery within 6 months prior to screening, or plan to receive surgical operations during the trial;
  4. Subjects who have taken any medicines or health supplements (including Chinese herbal medicines) within 14 days before dosing; or those who are known to require other drug treatments during the trial at screening.
  5. Subjects who have used any hepatic enzyme inhibitors/inducers within 1 month before dosing (inhibitors such as itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone; inducers such as carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.).
  6. Subjects who have participated in any clinical trials with investigational drugs/devices within 3 months prior to screening, or plan to participate in other clinical trials during the study.
  7. Subjects with a history of drug abuse or positive results in drug abuse screening;
  8. Subjects with clinically significant abnormal physical examination results at screening or baseline as judged by the investigator;
  9. Subjects with positive screening results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or treponema pallidum antibody;
  10. Subjects with cardiac diseases including but not limited to congenital long QT syndrome, torsades de pointes or risk factors for torsades de pointes (e.g., cardiac insufficiency, family history of long QT syndrome), those currently receiving Class IA anti-arrhythmic drugs (e.g., quinidine or procainamide), Class III anti-arrhythmic drugs (e.g., amiodarone or sotalol) or other drugs known to affect QT interval, or those with Fridericia-corrected QT interval (QTcF) ≥ 450 ms (male), QTcF ≥ 460 ms (female), PR interval > 200 ms or QRS interval ≥ 120 ms at screening;
  11. Subjects who fail pain test training as judged by the investigator (only applicable to groups requiring pain testing).

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: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Investigational Product (KR25102 for Injection)
Single-ascending-dose (5 mg, 10 mg, 20 mg, 30 mg, 45 mg, 60 mg) and multiple-ascending-dose (10 mg, 20 mg, 30 mg) intravenous administration of KR25102 for Injection.
Intravenous injection of KR25102 for Injection at different dose levels in SAD and MAD cohorts.
Comparador de Placebo: Placebo
Matching placebo for KR25102 for Injection, administered intravenously.
Intravenous injection of matching placebo.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence and Severity of Adverse Events (AEs)
Prazo: From study drug administration to 15 days after the last dose
including vital signs, physical examination (neurological examination and injection-site examination included), 12-lead electrocardiogram, laboratory tests, abdominal ultrasonography, etc.
From study drug administration to 15 days after the last dose

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Single-Dose Pharmacokinetic (PK) Parameters
Prazo: From study drug administration to 120 hours after single dose administration
AUC₀-ₜ
From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Prazo: From study drug administration to 120 hours after single dose administration
AUC₀-inf
From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Prazo: From study drug administration to 120 hours after single dose administration
Tmax
From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Prazo: From study drug administration to 120 hours after single dose administration
Tlag
From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Prazo: From study drug administration to 120 hours after single dose administration
Cmax
From study drug administration to 120 hours after single dose administration
Single-Dose Pharmacokinetic (PK) Parameters
Prazo: From study drug administration to 120 hours after single dose administration
t1/2
From study drug administration to 120 hours after single dose administration
Multiple-dose Pharmacokinetic (PK) Parameters
Prazo: From multiple-dose administration to 120 hours after the 7th dose
Cmin,ss
From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Prazo: From multiple-dose administration to 120 hours after the 7th dose
Ctrough
From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Prazo: From multiple-dose administration to 120 hours after the 7th dose
Cmax,ss
From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Prazo: From multiple-dose administration to 120 hours after the 7th dose
Cav,ss
From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Prazo: From multiple-dose administration to 120 hours after the 7th dose
AUCtau,ss
From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Prazo: From multiple-dose administration to 120 hours after the 7th dose
CLss
From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Prazo: From multiple-dose administration to 120 hours after the 7th dose
Tmax,ss
From multiple-dose administration to 120 hours after the 7th dose
Multiple-dose Pharmacokinetic (PK) Parameters
Prazo: From multiple-dose administration to 120 hours after the 7th dose
t1/2,ss
From multiple-dose administration to 120 hours after the 7th dose
QTcF Interval Changes and Correlation With Plasma Drug Concentration
Prazo: From study drug administration to 24 hours after dosing
Changes in QTcF interval relative to baseline (ΔQTcF), changes relative to placebo (ΔΔQTcF)
From study drug administration to 24 hours after dosing
QTcF Interval Changes and Correlation With Plasma Drug Concentration
Prazo: From study drug administration to 24 hours after dosing
changes relative to placebo (ΔΔQTcF)
From study drug administration to 24 hours after dosing

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Guoping Yang, The Third Xiangya Hospital, Central South University

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 (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

19 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de maio de 2026

Primeira postagem (Real)

1 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • KR25102-202601

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared due to commercial confidentiality and privacy protection 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 .