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临床试验/NL-OMON49281
NL-OMON49281已完成不适用

An open label, single centre, enabling study to investigate the optimum method for use of intradermal Substance P as a challenge agent in healthy participants - Intradermal Substance P challenge in healthy participants

GlaxoSmithKline Research & Development Limited0 个研究点目标入组 32 人开始时间: 待定最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
32
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99（—）

入选标准

  • •Participants are eligible to be included in the study only if all of the
  • •following criteria apply:
  • •1. Participant must be 18 to 50 years of age inclusive, at the time of signing
  • •the informed consent.
  • •Type of Participant and Disease Characteristics
  • •2. Participants who are overtly healthy as determined by medical evaluation
  • •including medical history, physical examination, laboratory tests, ECGs and
  • •vital signs.
  • •3. Participants who responded positive to histamine skin prick test and
  • •negative to saline injection at screening.
  • •4. Participants with Fitzpatrick skin type I-II (Caucasian).
  • •5. Body weight *50 kg and body mass index (BMI) within the range 19*29.9 kg/m2
  • •(inclusive).
  • •Sex and Contraceptive/Barrier Requirements
  • •6. Male participants are eligible to participate in the study
  • •- A female participant is eligible to participate if she is not pregnant or
  • •breastfeeding, and one of the following conditions applies:
  • •o Is a woman of non-childbearing potential (WONCBP) as defined in Section 10.4
  • •of the protocol: Contraceptive and Barrier Guidance.
  • •o Is a WOCBP and using a contraceptive method that is highly effective, with a
  • •failure rate of <1%, as described in Section 10.4 of the protocol during the
  • •intervention period. The investigator should evaluate potential for
  • •contraceptive method failure (e.g., noncompliance, recently initiated) in
  • •relationship to the first challenge.
  • •- A sensitive pregnancy test is required to be negative on the day of each
  • •This pregnancy test is able to detect a pregnancy near the threshold of
  • •implantation, correlating with the earliest point of potential exposure. Due to
  • •the short half-life of the interventions, a negative highly sensitive pregnancy
  • •test as scheduled in the protocol mitigates the risk of pregnancy exposure
  • •because exposure will be completely gone even with a worst case but unlikely
  • •scenario of conception occurring near the time of dosing. See Protocol Section
  • •8.2.5 Pregnancy Testing
  • •- If a urine test cannot be confirmed as negative (e.g., an ambiguous result),
  • •a serum pregnancy test is required. In such cases, the participant must be
  • •excluded from participation if the serum pregnancy result is positive.
  • •- Additional requirements for pregnancy testing during and after study
  • •intervention is located in Protocol Section 8.2.5 .
  • •- The investigator is responsible for review of medical history, menstrual
  • •history, and recent sexual activity to decrease the risk for inclusion of a
  • •woman with an early undetected pregnancy
  • •Informed Consent
  • •7. Capable of giving signed informed consent as described in Appendix 1 of the
  • •protocol which includes compliance with the requirements and restrictions
  • •listed in the informed consent form (ICF) and in this protocol.

排除标准

  • •Participants are excluded from the study if any of the following criteria apply:
  • •Medical Conditions
  • •1. Significant history of or current, cardiovascular (including hypotension,
  • •severe hypertension, vasomotor instability), respiratory (including asthma),
  • •renal, gastrointestinal, endocrine, haematological, infectious or neurological
  • •disorders constituting a risk when taking part in the study or interfering with
  • •the interpretation of data.
  • •2. History or presence of significant skin disorder (such as but not limited to
  • •chronic urticaria, atopic dermatitis, severe eczema, psoriasis or skin cancer).
  • •3. History of risk for or actual experience of complications from skin biopsy
  • •including excess bleeding, infection, or scarring/keloid formation.
  • •4. Abnormal blood pressure as determined by the investigator.
  • •5. Alanine transaminase (ALT) >1.5x upper limit of normal (ULN).
  • •6. Total bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if total
  • •bilirubin is fractionated and direct bilirubin <35%).
  • •7. Current or chronic history of liver disease, or known hepatic or biliary
  • •abnormalities (with the exception of Gilbert's syndrome or asymptomatic
  • •gallstones).
  • •8. QT interval corrected for heart rate according to Fridericia*s formula
  • •(QTcF) >450 msec, based on the mean of triplicate ECGs .
  • •NOTE: The QTc is the QT interval corrected for heart rate according to
  • •Fridericia*s formula (QTcF).
  • •Prior/Concomitant Therapy
  • •9. Use of any form of H1 or H2 antihistamine, tricyclic antidepressants, beta2
  • •agonists, dopamine, or beta blocking agents within 14 days before the first
  • •challenge visit through final assessments.
  • •10. Use of topical medications such as but not limited to retinoids, steroids,
  • •and transdermal hormone replacement therapies on or near the intended site of
  • •application within 8 weeks prior to dosing through treatment follow up. Use of
  • •other topical preparations such as those containing vitamins, supplements or
  • •herbal within 2 weeks prior to dosing through treatment follow up.
  • •11. Past or intended use of any other non-topical over-the-counter or
  • •prescription medication, including herbal medications, within 7 days before the
  • •first challenge visit, unless, in the opinion of the investigator and GSK
  • •Medical Monitor, the medication will not constitute a risk when taking the
  • •study intervention or interfere with the interpretation of data.
  • •Prior/Concurrent Clinical Study Experience
  • •12. Participation in the study would result in loss of blood or blood products
  • •in excess of 500 mL within 3 months.
  • •13. Current enrolment in any clinical study involving an investigational study
  • •intervention or any other type of medical research.
  • •14. Current enrolment or past participation in this study.
  • •Diagnostic assessments
  • •15. Presence of Hepatitis B surface antigen (HBsAg) or hepatitis B core
  • •antibody (HbcAb) at screening or within 3 months before the first challenge day.
  • •16. Positive Hepatitis C antibody test result at screening or within 3 months
  • •before the first challenge day.
  • •NOTE: Subjects with positive Hepatitis C antibody due to prior resolved disease
  • •can be enrolled, only if a confirmatory negative Hepatitis C RNA test is
  • •17. Positive Hepatitis C RNA test result at screening or within 3 months before
  • 另有 2 项未显示

研究者

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