A Phase I, Open Label, Controlled Study of Valortim® (MDX-1303) and Its Selected Formulation Components When Introduced Percutaneously in Subjects Who Have and Have Not Been Exposed to Valortim Administered Intravenously
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Skin Testing Results
研究概览
简要总结
The purpose of this study is to determine if Valortim, or one or more of its selected formulation components, induces a wheal reaction when introduced percutaneously.
Two of 4 subjects dosed in a previous study with a modified formulation of Valortim experienced treatment related adverse events which were suggestive of allergic or allergic-like reactions. In order to better characterize these reactions and determine if they represent allergic or allergic-like reactions to Valortim or one or more of its components, skin testing of Valortim and selected components on naïve and Valortim-exposed subjects will be performed in this study
详细描述
A maximum of 7 subjects will participate in the study. Up to four of these subjects have been previously exposed to IV Valortim.
The study will be conducted in two stages. The first stage will be performed on subjects not previously exposed to Valortim (Valortim-naïve subjects), to determine the correct dilutions of the test components. The second stage will be performed on the Valortim-exposed subjects using the dilutions of test components as determined in the first stage of the study.
The following components will be tested to determine their ability to induce a wheal reaction shortly after exposure to the skin by percutaneous application by needle prick: Valortim (Lot# 10-08-001), polysorbate 80, mannitol, histamine (positive control), and saline (negative control). All components except histamine will be provided to the clinical site by PharmAthene with detailed instructions for handling, storage, and dilution. A tiny drop of the aforementioned components will be introduced onto the surface of the skin and the skin will be pricked, allowing the components to enter the surface of the skin. Multiple components will be tested on the subjects' forearms or back; location of testing to be determined by scars, moles,pre-existing skin lesions, or other issues deemed by the Principal Investigator (PI) to have the potential to interfere with interpretation of the results.
Stage I:
- 3 Valortim-naïve, non-allergic subjects
- Only one subject will be skin tested in a single day
- Subjects will be tested percutaneously with the above mentioned components at the following dilutions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage I Subjects
- •In the opinion of the Investigator, subjects should be in generally good health, based upon pre-study medical history and abbreviated physical exam.
- •Female subjects cannot be pregnant, as confirmed by a negative urine pregnancy test at Study Day 1, prior to skin testing.
- •Women of childbearing potential may be enrolled if one of the following criteria applies:
- •Must be using an effective form of contraception for at least one month prior to study entry, must have a negative urine pregnancy test on Day 1, prior to skin testing
- •Is sexually abstinent
- •Is monogamous with a vasectomized partner (>3 months prior)
- •Is postmenopausal (i.e. no cycle for at least the previous 12 months, is of menopausal age (>45 years) and has a negative urine pregnancy test on Day 1, prior to skin testing
- •Is surgically sterilized
- •Has had a total hysterectomy
- •Sexually active male subjects may be enrolled if one of the following criteria applies:
- •Has had a vasectomy
- •Using condoms and whose partner is using an acceptable form of contraception *Is sexually abstinent.
- •In addition to the Inclusion Criteria above, Stage II Subjects must also meet the following criteria :
- •Must have participated in PharmAthene Study #0036-08-05 and have been previously exposed in that study to Valortim.
排除标准
- •Stage I & II
- •Antihistamine use within 14 days of testing. Medications with antihistamine properties (i.e., anticholinergic agents, phenothiazine), beta-blockers, MAO-inhibitors or tricyclic antidepressant use within 1 day of testing.
- •Dermatographia, or extreme skin sensitivity.
- •History of allergic rhinitis, asthma or eczema.
- •Outward signs of active allergies or upper respiratory infection.
- •Known pregnancy as confirmed by urine pregnancy testing on Day 1, prior to skin testing procedures.
研究组 & 干预措施
Stage I
Three (3) healthy male or female volunteers aged 18-59 years, not previously exposed to Valortim and who do not have pre-existing allergies
干预措施: Valortim and Selected Components (Drug)
Stage II
Up to 4 healthy male or female volunteers aged 18-59 previously exposed to intravenous (IV) Valortim in PharmAthene Study #0036-08-05
干预措施: Valortim and Selected Components (Drug)
结局指标
主要结局
Skin Testing Results
时间窗: Initial results assessed after 15minutes and up to 72 hours.
Assessment of any wheal reaction from the study drug or its selected components and how this compares to the positive and negative control
次要结局
未报告次要终点