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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 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 Between 6 and 96 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
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 基础科学
- 盲法
- 开放(无盲法)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
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)
- Otherwise healthy on the basis of physical examination, medical history, and vital signs, and if required by the applicable Intervention Specific Appendix (ISA), a 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant or consistent with the disease of interest, as specified in the applicable ISA. This determination must be recorded in the participant's source documents and initialed by the investigator
- Otherwise 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
- Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 [COVID-19]) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to administration of study intervention
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 20 weeks after study intervention administration
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, unless consistent with the underlying disease of interest in the study population, if applicable
- History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia, unless consistent with the underlying disease of interest in the study population, if applicable. 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 (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Known allergies, hypersensitivity, or intolerance to secukinumab or its excipients
- Has surgery planned within 20 weeks after the study intervention administration
研究组 & 干预措施
Candin + Cosentyx
Participants will receive a single dose of candin injection intradermally on Day 6 along with a single dose of saline solution injection of 0.9 percent (%) sodium chloride (NaCl) and a single dose of Cosentyx injection subcutaneously on Day 1.
干预措施: Candin (Drug)
Candin + Cosentyx
Participants will receive a single dose of candin injection intradermally on Day 6 along with a single dose of saline solution injection of 0.9 percent (%) sodium chloride (NaCl) and a single dose of Cosentyx injection subcutaneously on Day 1.
干预措施: Cosentyx (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 Between 6 and 96 Hours After Candin Challenge
时间窗: Day 7
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 between 6 and 96 hours after Candin challenge will be reported.
次要结局
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) in the Active Arm Versus the Control Arm(Up to Day 30)
- Number of Participants with Treatment-emergent Serious Adverse Events (SAEs) in the Active Arm Versus the Control Arm(Up to Day 30)
- 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 Day 30)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05522517
- 其他研究编号
- CR109261, 2022-001636-29, NOPRODPANAP1004
日期
- 首次提交
- (4年前)
- 首次发布
- (4年前)
- 主要完成日期
- (3年前)
- 研究完成日期
- (3年前)
- 最近核实
- 最近更新
- (去年)
监管与共享
- FDA 监管药物
- 是
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
