NCT04985955已完成1 期
A Phase 1, Single Center, Randomized, Controlled Platform Study Validating the Use of Candin as a Challenge Agent in Healthy Volunteers or Patients Given Concomitant Approved Interventions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants with Presence and Size of Induration in Active Versus Control at the Candin Injection Site Compared to the Intra-individual Saline Control Injection Site Approximately 48 Hours After Candin Challenge
研究概览
简要总结
The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response at the site of Candin intradermal injection in the presence of a targeted immune pathway inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m^2) (BMI = weight/height^2), inclusive, and a body weight of no less than 50 kilograms (kg)
- •Healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- •Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Must sign an informed consent forms (ICFs) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- •A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after the last dose of study intervention
排除标准
- •History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic, or mucocutaneous disturbances
- •History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- •Has experienced a recent single dermatomal herpes zoster eruption within the past 6 months or has had multi-dermatomal herpes zoster or central nervous system zoster within the past 5 years
- •Has surgery planned within 30 days after study intervention administration
研究组 & 干预措施
Candin + Tofacitinib
Experimental
Participants will receive a single dose of Candin injection on forearm of 1 arm along with a saline solution injection of 0.9 percent (%) sodium chloride (NaCl) on the opposite forearm on Day 3 and oral dose of tofacitinib for 5 days.
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Number of Participants with Presence and Size of Induration in Active Versus Control at the Candin Injection Site Compared to the Intra-individual Saline Control Injection Site Approximately 48 Hours After Candin Challenge
时间窗: Day 5
Number of participants with presence and size of induration in active versus control at the Candin injection site compared to the intra-individual saline control injection site approximately 48 hours after Candin challenge will be reported.
次要结局
- Number of Participants with Treatment-emergent Serious Adverse Events (SAEs) in the Active Arm Versus the Control Arm(Up to 6 weeks)
- Number of Participants with TEAEs by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More in the Active Arm Versus the Control Arm(Up to 6 weeks)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) in the Active Arm Versus the Control Arm(Up to 6 weeks)
研究者
研究点 (1)
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