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Study of GS-0415 and How It Works in People With HIV

2026年9月21日 更新者：Gilead Sciences

A First-in-Human Phase 1b, Single-Blind, Placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate Safety and Pharmacokinetics of GS-0415 in People With HIV-1 Who Are Virologically Suppressed on Antiretroviral Treatment

The goals of this clinical study are to learn more about the study drug GS-0415, safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of subcutaneous (SC) and intravenous (IV) GS-0415 in people with HIV-1 (PWH) on antiretroviral treatment.

The primary objectives of this study are to evaluate the safety and tolerability of escalating, single and multiple subcutaneous (SC) and intravenous (IV) doses of GS-0415, administered in PWH who are virologically suppressed on antiretroviral therapy (ART) and to evaluate the pharmacokinetics (PK) of GS-0415.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

112

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。

学习联系方式

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90027
        • 招聘中
        • Kaiser Permanente Los Angeles Medical Center
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20007
        • 招聘中
        • Georgetown University Medical Center
    • Florida
      • Miami Lakes、Florida、美国、33016
        • 招聘中
        • Floridian Clinical Research, LLC
      • West Palm Beach、Florida、美国、33407
        • 招聘中
        • Triple O Research Institute, P.A.
    • Georgia
      • Atlanta、Georgia、美国、30308
        • 招聘中
        • Emory University Hospital Midtown Infectious Disease Clinic
      • Columbus、Georgia、美国、31904
        • 招聘中
        • Centricity Research CPU - Georgia
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • 招聘中
        • Indiana CTSI Clinical Research Center
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • 招聘中
        • Brigham and Women's Hospital
      • Boston、Massachusetts、美国、02118
        • 招聘中
        • Boston Medical Center
    • Nevada
      • Las Vegas、Nevada、美国、89113
        • 招聘中
        • PPD Development, LP
    • New Jersey
      • Newark、New Jersey、美国、07102
        • 尚未招聘
        • St. Michaels Medical Center
    • New York
      • The Bronx、New York、美国、10461
        • 招聘中
        • Jacobi Medical Center
    • North Carolina
      • Durham、North Carolina、美国、27710
        • 招聘中
        • Duke Early Phase Clinical Research Unit
      • Winston-Salem、North Carolina、美国、27157
        • 招聘中
        • Wake Forest University Health Sciences
    • Ohio
      • Cincinnati、Ohio、美国、45267
        • 招聘中
        • University of Cincinnati College of Medicine
      • Columbus、Ohio、美国、43210
        • 招聘中
        • The Ohio State University Medical Center Infectious Diseases Clinic

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 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key Inclusion Criteria:

  • Age ≥ 18 years and age ≤ 65 years at screening
  • On stable antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to screening, throughout the duration of study treatment and follow-up
  • The following ARV agents are not allowed as part of the current ART regimen: entry inhibitors (maraviroc, enfuvirtide, ibalizumab, or fostemsavir)
  • Plasma HIV-1 RNA < 50 copies/mL for ≥ 12 months before and at screening with at least 2 documented HIV-1 RNA <50 copies/mL within the last 12 months.
  • Clusters of differentiation 4 (CD4) count ≥ 350 cells/μL
  • Weight ≥ 50 kg and ≤ 110 kg at screening and Day 1
  • Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 35 kg/m2 at screening and Day 1

Key Exclusion Criteria:

  • Documented history of pre-ART CD4 nadir < 100 cells/μL. Unknown pre-ART CD4 nadir is acceptable

  • Known to have initiated ART within 6 months of HIV infection. Unknown time between infection and ART initiation is acceptable

  • Females who are pregnant or breastfeeding or who may wish to become pregnant during the study or within 42 days after last study drug administration

  • Have chronic hepatitis B virus (HBV) as determined by either:

    1. Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit
    2. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the Screening visit

  • Have active hepatitis C virus (HCV) infection:

    1.) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable

  • Have a history of any of the following:

    2.) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria as assessed by the investigator

    3.) Significant drug sensitivity or drug allergy ('but not limited to anaphylaxis or drug-induced liver injury) as assessed by the investigator

    4.) Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients

    5.) Previous or current history of bleeding disorder, platelet disorder including unexplained acute or chronic thrombocytopenia

    6.) Autoimmune diseases including Type 1 diabetes mellitus

    7.) Serious or active medical or psychiatric illness that would interfere with participant treatment, assessment, or compliance with the protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Group A Single Ascending Dose (SAD): GS-0415

Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1.
药品：GS-0415

Administered SC or IV
实验性的：Group A SAD: Placebo

Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.
药品：GS-0415 Placebo

Administered SC or IV
实验性的：Group B SAD: GS-0415

Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1.
药品：GS-0415

Administered SC or IV
实验性的：Group B SAD: Placebo

Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.
药品：GS-0415 Placebo

Administered SC or IV
实验性的：Group C Multiple Ascending Dose (MAD): GS-0415

Participants will receive escalating doses of GS-0415 via SC or IV at five different timepoints up to Date 57.
药品：GS-0415

Administered SC or IV
实验性的：Group C MAD: Placebo

Participants will receive placebo to match escalating doses of GS-0415 via SC or IV at five different timepoints up to Day 57.
药品：GS-0415 Placebo

Administered SC or IV

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
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
大体时间：First dose date up to 99 days
First dose date up to 99 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
大体时间：First dose date up to 99 days
First dose date up to 99 days
Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145
大体时间：Up to 99 days
Up to 99 days
Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145
大体时间：Up to 43 days

AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
Up to 43 days
Serum PK Parameters (SAD): Cmax of GS-0145
大体时间：Up to 43 days

Cmax is defined as the maximum observed concentration of drug.
Up to 43 days
Serum PK Parameters Multiple Ascending Dose (MAD): Dose 1 and Dose 5: AUCtau of GS-0145
大体时间：Up to 99 days

AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Up to 99 days

次要结果测量

结果测量
大体时间
Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies
大体时间：Up to 99 days
Up to 99 days
Percentages of participants With Virological Rebound (Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL)
大体时间：Up to 99 days
Up to 99 days

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

Gilead Sciences

调查人员

  • 研究主任：Gilead Study Director、Gilead Sciences

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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)

2026年7月22日

初级完成 (估计的)

2029年8月1日

研究完成 (估计的)

2029年8月1日

研究注册日期

首次提交

2026年7月17日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • GS-US-531-7345

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

是的

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.

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