- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07924761
A Study to Investigate the Effect of Injection Site and Ethnicity on KAI-4729 Pharmacokinetics in Non-Asian and Asian Participants Living With Obesity or Overweight
A Phase 1, Randomized, Open-Label, Single-Dose Study to Investigate the Effect of Injection Site on Relative Bioavailability of KAI-4729 Subcutaneous Injection and Pharmacokinetics of KAI-4729 in Non-Asian and Asian Participants Living With Obesity or Overweight
The main objectives of this study are to assess the relative bioavailability of KAI-4729 subcutaneous (SC) injection in the upper arm and thigh compared with the abdomen and to measure the pharmacokinetics of KAI-4729 in plasma following a single SC dose in healthy non-Asian and Asian participants.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Kailera Therapeutics, Inc.
- Número de telefone: 1-781-317-0291
- E-mail: info-clinicalstudies@kailera.com
Locais de estudo
-
-
California
-
Anaheim, California, Estados Unidos, 92801
- Kailera Clinical Site
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Key Inclusion Criteria:
- Have a body mass index (BMI) ≥25 and ≤40 kilograms per square meter at screening (Days -28 to -2) and on Day -1 of the first Treatment Period
- Non-Asian Participants Only: Be of non-Asian descent and not identify as being of East Asian origin
- Asian Participants Only: Be of Asian descent, identify as being of East Asian origin, and have both parents and both sets of grandparents born in East Asia and of East Asian descent
- Medically healthy
Key Exclusion Criteria:
- Have estimated glomerular filtration rate <60 milliliters/minute/1.73 square meters at screening (Days -28 to -2) using the 2021 Chronic Kidney Disease Epidemiology Collaboration calculation.
- Have hemoglobin A1c test result ≥6.5% or blood glucose ≥126 milligrams/deciliter (≥7 millimoles/liter) at screening (Days -28 to -2).
- Have a history of, or positive test results at screening (Days -28 to -2) for, human immunodeficiency virus (HIV), hepatitis B surface antigen, or active hepatitis C virus infection.
- Have positive drugs of abuse or alcohol test results at screening (Days -28 to -2) or on Day -1 of each Treatment Period.
- Be pregnant or planning to be pregnant and/or breastfeeding or planning to breastfeed during the study and within 5 half-lives of the study drug (25 days) following the last study treatment dose.
- Have any history of malignant disease, including in situ cervical or prostate cancer, within the 5 years prior to informed consent (excludes basal or squamous cell carcinoma that was successfully treated).
- Have history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the 3 months prior to informed consent determined by the Investigator (or delegate) to be clinically relevant.
- Have known hypersensitivity to the study drug; glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide, and/or glucagon receptor agonist therapies; or any of the study drug ingredients.
- Have any other conditions or received prior therapy that, in the opinion of the Investigator (or delegate), would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Upper Arm Injection Site
Participants will receive KAI-4729 as a single SC injection into the upper arm on Day 1 of either Treatment Period 1, 2, or 3. |
SC injection |
|
Experimental: Abdomen Injection Site
Participants will receive KAI-4729 as a single SC injection into the abdomen on Day 1 of either Treatment Period 1, 2, or 3. |
SC injection |
|
Experimental: Thigh Injection Site
Participants will receive KAI-4729 as a single SC injection into the thigh on Day 1 of either Treatment Period 1, 2, or 3. |
SC injection |
|
Experimental: Abdomen Injection Site (Asian Participants)
Asian participants will receive KAI-4729 as a single SC injection into the abdomen on Day 1 of Treatment Period 1. |
SC injection |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Prazo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Prazo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Prazo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
|
Cmax of KAI-4729 in Healthy Non-Asian and Asian Participants
Prazo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
|
AUC0-t of KAI-4729 in Healthy Non-Asian and Asian Participants
Prazo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
|
AUC0-inf of KAI-4729 in Healthy Non-Asian and Asian Participants
Prazo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Prazo: Day 1 to Day 99
|
Day 1 to Day 99
|
|
Number of Participants Who Experience a Serious Adverse Event (SAE)
Prazo: Day 1 to Day 99
|
Day 1 to Day 99
|
|
Number of Participants Who Experience Antidrug Antibodies (ADAs) to KAI-4729
Prazo: Treatment Period 1, 2 and 3: Day 1, Day 8, Day 29 post-dose
|
Treatment Period 1, 2 and 3: Day 1, Day 8, Day 29 post-dose
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Medical Director, Kailera Therapeutics, Inc.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- K4729-1115
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .