NCT01140126已完成1 期
A Phase I, Open-label, Single-dose, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults
United Biomedical2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421.
研究概览
简要总结
The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic, treatment-naive, HIV-1 seropositive
- •CD4+ T cell count >350 cells/cubic millimeter
- •HIV-1 viral load >5,000 copies/mL
- •Other inclusion criteria apply
排除标准
- •Active infection requiring immediate therapy (except HIV-1)
- •Prior participation in any HIV vaccine trial
- •Previous exposure to a monoclonal antibody
- •Use of immunomodulating drugs or systemic chemotherapy
- •Other exclusion criteria apply
研究组 & 干预措施
Antibody (UB-421)
Experimental
干预措施: Antibody UB-421 (Drug)
结局指标
主要结局
To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421.
时间窗: Screen, treatment & follow-up: 62 to 90 days
次要结局
- To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421.(Screen, treatment & follow-up: 62 to 90 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Study to Evaluate Safety and Efficacy of UB-421 Antibody in HIV-1 Infected AdultsHIV-1 Infection in AdultsNCT01668043United Biomedical29
已完成
1 期
Phase 1 Dose Escalation Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected PatientsHIV InfectionHIV InfectionsNCT01044654Sangamo Therapeutics19
已完成
1 期
Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children With HIV-1 InfectionHIV InfectionNCT00001445National Cancer Institute (NCI)32
已完成
1 期
Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected AdultsHIV InfectionsNCT00119873National Institute of Allergy and Infectious Diseases (NIAID)48
Unknown
1 期
Study of Single IV Administration of P2G12HIV InfectionNCT02923999St George's, University of London18