此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

一项调查 VXX-401 与安慰剂在成人参与者中的安全性、耐受性、免疫原性和药效学的研究

2026年11月2日 更新者：Axxium Life, Inc.

一项 1 期、首次人体、随机、双盲、安慰剂对照、剂量递增研究，以评估 VXX-401 在健康成人中的安全性、耐受性、免疫原性和药效学

This first-in-human (FIH) study of VXX-401, an anti-PCSK9 peptide-based immunotherapeutic candidate, is designed to assess the safety, tolerability, immunogenicity, and pharmacodynamics (PD) of VXX-401 and to determine an optimal dose regimen for LDL-C lowering in subsequent clinical trials.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is multisite, multidose regimen, phase 1, first-in-human study of VXX-401, a synthetic peptide-based active immunotherapy candidate for preventing and treating hypercholesterolemia. The study will include Screening, Treatment, and Follow-up Periods. This study will enroll participants who are naïve to statin use. Each cohort from A to D is planned to randomize approximately 12 participants to receive doses of VXX-401 or placebo in a 3:1 ratio. Cohorts E and F will dose approximately 8 participants in each cohort to receive doses of VXX-401. No participants will be administered placebo in Cohorts E and F. It is planned to test up to 6 dose regimens of VXX-401, administered by IM injection into the deltoid muscle (and additionally in the thigh for the first dose in Cohorts E-F.). All eligible participants will receive a priming regimen at Week 0 (Baseline, Day 1), Week 4, and Week 12, in Cohorts A, C, E and F, and additionally at Week 8 in Cohorts B and D. The last dose administration will be at Week 12.

研究类型

介入性

注册 (实际的)

64

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 澳大利亚
    • New South Wales
      • Brookvale、New South Wales、澳大利亚
        • Northern Beaches Clinical Research
      • Miranda、New South Wales、澳大利亚
        • Sutherland Shire Clinical Research
      • Sydney、New South Wales、澳大利亚
        • Emeritus Research
    • Queensland
      • Morayfield、Queensland、澳大利亚
        • University of the Sunshine Coast (USC)
    • Victoria
      • Melbourne、Victoria、澳大利亚
        • Emeritus Research

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Male or female participants aged 18 to 75 years old, inclusive, at time of informed consent.
  2. LDL-C level = 2.59 mmol/L - 4.89mmol/L
  3. Body mass index between 18 and 35 kg/m2, inclusive at Screening, and with a minimum weight of 50 kg.
  4. Male participants and their partners of childbearing potential must commit to the use of highly effective contraceptives for the study duration and for at least 12 weeks after the last dose. Men must refrain from donating sperm during this same period.
  5. Female participants must be of nonchildbearing potential, or, for women of childbearing potential, must be willing to practice at least one form of highly effective contraception throughout the duration of the study and for at least 24 weeks following the last dose. Female participants must refrain from donating reproductive tissue during this same period.

Exclusion Criteria:

  1. Subjects considered high risk or very high risk for ASCVD and requiring immediate treatment with LLT according to the clinical judgement of the investigator.
  2. History of confirmed anergy (i.e., not able to mount an immunological response) or history of immunization failure in the 5 years prior to the Screening Visit.
  3. Presence of fever >38°C or other signs or symptoms of acute disease within 1 week before the Screening and/or Visit 1; Screening and/or Visit 1 may be rescheduled at the discretion of the Investigator but must occur within the 4-week window.
  4. Known disturbance of coagulation or medication (see prohibited medications criterion below); bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
  5. Triglycerides > 5.65 mmol/L
  6. Has a history of clinically significant medical disorder or psychiatric conditions, which in the opinion of the investigator may compromise the participant's safety and ability to comply with study procedures or abide by study restrictions.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：VXX-401 Cohort A

VXX-401 100mcg administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12
药品：VXX-401

A synthetic PCSK9 peptide-based immunotherapy
实验性的：VXX-401 Cohort B

VXX-401 100mcg administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12
药品：VXX-401

A synthetic PCSK9 peptide-based immunotherapy
实验性的：VXX-401 Cohort C

VXX-401 300mcg administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12
药品：VXX-401

A synthetic PCSK9 peptide-based immunotherapy
实验性的：VXX-401 Cohort D

VXX-401 300mcg administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12
药品：VXX-401

A synthetic PCSK9 peptide-based immunotherapy
安慰剂比较：Placebo Cohort A and C

Placebo administered by intramuscular (IM) injection at Week 0, Week 4, and Week 12
生物：Placebo

Normal saline
安慰剂比较：Placebo Cohort B and D

Placebo administered by intramuscular (IM) injection at Week 0, Week 4, Week 8 and Week 12
生物：Placebo

Normal saline
实验性的：VXX-401 Cohort E

VXX-401 900mcg administered by intramuscular (IM) injection at Week 0. VXX-401 100 mcg administered by intramuscular (IM) injection at Week 4 and Week 12.
药品：VXX-401

A synthetic PCSK9 peptide-based immunotherapy
实验性的：VXX-401 Cohort F

VXX-401 900mcg administered by intramuscular (IM) injection at Week 0. VXX-401 300 mcg administered by intramuscular (IM) injection at Week 4 and Week 12.
药品：VXX-401

A synthetic PCSK9 peptide-based immunotherapy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Frequency of adverse events
大体时间：30 weeks

Safety and tolerability: rates of adverse events (AEs), medically attended adverse events (MAAEs), local (injection site) and systemic (generalized) reactions (i.e., reactogenicity), clinical laboratory assessments (e.g., chemistry, hematology, urinalysis, lipid profile), serum cytokine release, vital signs, physical examinations, and electrocardiograms (ECGs) through the end of the study.
30 weeks
Immunogenicity
大体时间：Baseline to Week 16, 20, 24, and 30

Immunogenicity will be measured by serum anti-PCSK9 antibody titers
Baseline to Week 16, 20, 24, and 30
Immunogenicity
大体时间：Baseline to Week 16, 20, 24, and 30

Seroconversion two-fold and four-fold from baseline
Baseline to Week 16, 20, 24, and 30
Determine optimal VXX-401 dose regimen
大体时间：Baseline to Week 16, 20, 24, and 30

Measured by serum anti-PCSK9 antibody titers
Baseline to Week 16, 20, 24, and 30

次要结果测量

结果测量
措施说明
大体时间
Evaluation of low-density lipoprotein-cholesterol (LDL-C) reduction
大体时间：Baseline to Week 16, 20, 24, and 30

Percent change from baseline in serum LDL-C concentration
Baseline to Week 16, 20, 24, and 30

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Axxium Life, Inc.

合作者

Novotech (Australia) Pty Limited

调查人员

  • 研究主任：Sasha Rumyantsev、Vaxxinity, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年3月7日

初级完成 (实际的)

2024年7月25日

研究完成 (实际的)

2024年7月25日

研究注册日期

首次提交

2023年2月20日

首先提交符合 QC 标准的

2023年3月7日

首次发布 (实际的)

2023年3月9日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • VXX-401-101

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅