A Phase 1 Study of Nexvax2 Administered Subcutaneously After a Screening Gluten Food Challenge That Compares Relative Bioavailability With Intradermal Administration in Non-homozygous HLA-DQ2.5+ Adults With Celiac Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration
研究概览
简要总结
A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).
详细描述
A Phase 1, randomized,double-blind, placebo-controlled clinical study of Nexvax2, in adult subjects with confirmed CeD who, have been following a gluten free diet for at least 12 consecutive months prior to screening. The study will evaluate the safety and tolerability of Nexvax2 administered subcutaneously and will compare the bioavailability of subcutaneous versus intradermal administration. The study plan consists of 3 periods: a screening period of 3 to 5 weeks, a 46-day treatment period, and a 30-day post-treatment observational follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 to 70 years of age (inclusive)
- •History of medically diagnosed Celiac Disease (CeD) that included duodenal biopsy.
- •Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
- •Willingness to consume a moderate amount of gluten on one occasion during screening.
- •Able to read and understand English.
排除标准
- •History of inflammatory bowel disease and/or microscopic colitis.
- •Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
- •Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
- •Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
- •Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
- •Females who are lactating or pregnant
- •Receipt of any vaccine within 1 week prior to planned first day of the treatment period.
研究组 & 干预措施
Nexvax2 (Arm B)
干预措施: Nexvax2 (Biological)
Nexvax2 (Arm A)
干预措施: Nexvax2 (Biological)
Nexvax2 Placebo (Arm D)
干预措施: Placebo (Biological)
Nexvax2 Placebo (Arm C)
干预措施: Placebo (Biological)
结局指标
主要结局
Evaluate bioavailability of the constituents of Nexvax2 after SQ versus intradermal (ID) administration
时间窗: Treatment Period: 7 weeks
Blood draws for plasma concentration
Safety of Nexvax 2 administered subcutaneously (SQ)
时间窗: Treatment Period: 7 weeks
Treatment emergent adverse events (TEAEs) will be summarized by treatment group and treatment arm, severity (grades as defined in CTCAE, Version 4.03), relationship to IP, and phase of treatment and presented as the number and percentage of patients reporting an event(s) as well as the number of events reported.
次要结局
- Evaluate area under the plasma concentration-time curve for the constituents of Nexvax2 in SQ versus ID maintenance doses.(Treatment Period: 7 weeks)
- Compare elimination half life properties for the constituents of Nexvax2 in SQ versus ID maintenance doses.(Treatment Period: 7 weeks)
- Evaluate the pharmacodynamics (PD) of the maintenance dose levels of Nexvax2 administered SQ and ID(Treatment Period: 7 weeks)
- Compare time to maximal plasma concentration for the constituents of Nexvax2 in SQ versus ID maintenance doses.(Treatment Period: 7 weeks)