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Study of HXN6005 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis

19 de agosto de 2026 atualizado por: Helixon Biotechnology (Suzhou) Co., Ltd

A Phase I/II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HXN6005 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis

This is a Phase I/II, multicenter, randomized, double-blind, placebo-controlled study evaluating HXN6005 in healthy participants and patients with moderate-to-severe atopic dermatitis (AD).

The study consists of three parts: Part A (single ascending dose in healthy participants), Part B (multiple ascending dose in AD patients), and Part C (multiple-dose efficacy and safety assessment in AD patients).

The primary objectives are to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HXN6005.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Part A (Single Ascending Dose, SAD) is a randomized, double-blind, placebo-controlled, single-dose escalation design conducted in healthy participants. It includes two sequential dose cohorts. A total of 16 healthy participants are planned, with 8 participants per cohort (6 receiving HXN6005 and 2 receiving placebo). Participants receive a single subcutaneous injection of HXN6005 or placebo. All participants are followed for safety, PK, PD, and anti-drug antibody (ADA) assessments.

Part B (Multiple Ascending Dose, MAD) is a randomized, double-blind, placebo-controlled study conducted in patients with moderate-to-severe AD. Part B enrolls 16 patients across two dose cohorts, with 8 patients per cohort (6 receiving HXN6005 and 2 receiving placebo). Patients receive multiple subcutaneous injections of HXN6005 or placebo according to the study schedule.

Part C is a multicenter, randomized, double-blind, placebo-controlled study conducted in patients with moderate-to-severe AD. A total of 35 patients are planned to be randomized into two HXN6005 dose groups and one placebo group, receiving multiple subcutaneous doses according to the study schedule. Regular follow-up visits are conducted to collect efficacy data, safety data, and blood samples for assessment of systemic exposure, immunogenicity, and biomarkers.

Tipo de estudo

Intervencional

Inscrição (Estimado)

67

Estágio

  • Fase 2
  • 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

Locais de estudo

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006

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
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  1. Participants must be able to understand and comply with the study requirements and voluntarily sign the informed consent form (ICF).
  2. (Healthy Participants) Male or female participants aged 18 to 55 years (inclusive) at the time of signing the ICF.
  3. (Healthy Participants) Male participants weighing ≥ 50.0 kg and female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 18.0 and 28.0 kg/m² (inclusive).
  4. (Patients with AD) Male or female participants aged 18 to 70 years (inclusive) .
  5. (Patients with AD) Participants must have documented AD history, moderate-to-severe disease, and inadequate response to topical therapy at screening.

Exclusion Criteria:

  1. Presence of any clinically significant disease at randomization, as judged by the investigator.
  2. Known or suspected allergy or intolerance to any component or excipient of HXN6005 injection or placebo.
  3. History of severe drug allergy or systemic anaphylactic reactions, such as anaphylactic shock, laryngeal edema, etc.
  4. Known or suspected history of immunosuppression, or history of invasive opportunistic infections, including infections that are unusually frequent, recurrent, or prolonged in duration as judged by the investigator, even after resolution of the infection.
  5. History of malignancy or malignant disease, with the exception of surgically excised cutaneous squamous cell carcinoma in situ, basal cell carcinoma, and cervical carcinoma in situ that have been in complete remission for more than 5 years without any evidence of recurrence.

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: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Part A Single Ascending Dose (SAD)
Participants will receive a single subcutaneous dose of HXN6005
Medicamento: HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Medicamento: HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Medicamento: HXN6005
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Comparador de Placebo: Part A Placebo (SAD)
Participants will receive a single subcutaneous dose of placebo
Medicamento: Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
Medicamento: Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Medicamento: Placebo
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
Experimental: Part B Multiple Ascending Dose (MAD)
Participants will receive multiple subcutaneous doses of HXN6005
Medicamento: HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Medicamento: HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Medicamento: HXN6005
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Comparador de Placebo: Part B Placebo (MAD)
Participants will receive multiple subcutaneous doses of placebo
Medicamento: Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
Medicamento: Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Medicamento: Placebo
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
Experimental: Part C Multiple Dose efficacy exploration
Participants will receive multiple subcutaneous doses of HXN6005
Medicamento: HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Medicamento: HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Medicamento: HXN6005
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Comparador de Placebo: Part C Multiple Dose placebo-controlled
Participants will receive multiple subcutaneous doses of placebo
Medicamento: Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
Medicamento: Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Medicamento: Placebo
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Part A Adverse events
Prazo: Up to day 141
Incidence, severity, and causal relationship of Adverse Events (AEs)
Up to day 141
Part B Adverse Events
Prazo: Up to day 197
Incidence, severity, and causal relationship of Adverse Events (AEs)
Up to day 197
Part C Efficacy
Prazo: Up to day 113
Change from baseline to Week 16 in the Eczema Area and Severity Index (EASI; range 0-72; higher scores indicate more severe disease) total score among AD participants
Up to day 113

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Maximum Observed Plasma Concentration (Cmax)
Prazo: Up to day 197
The maximum (peak) observed drug concentration in plasma after administration
Up to day 197
Area Under the Plasma Concentration-Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t)
Prazo: Up to day 197
Area under the plasma concentration-time curve from time 0 (pre-dose) to the time of the last measurable (quantifiable) plasma concentration
Up to day 197
Incidence of antidrug antibodies (ADA) against HXN6005
Prazo: Up to day 197
The incidence of treatment-emergent ADA against HXN6005 was assessed in serum samples
Up to day 197

Colaboradores e Investigadores

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

Patrocinador

Helixon Biotechnology (Suzhou) Co., Ltd

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 setembro de 2026

Conclusão Primária (Estimado)

1 de outubro de 2027

Conclusão do estudo (Estimado)

1 de janeiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

13 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de agosto de 2026

Primeira postagem (Real)

24 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • HXN6005-A1-201

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

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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