NL-OMON55004已完成不适用
A randomized, double-blind, placebo-controlled, three-period two treatment incomplete-block crossover study to investigate the effects of intravenous GSK3858279 on a battery of evoked pain tests in healthy participants. - GSK3858279 vs PBO, Phase 1, Pain Tests, PK and Target Engagement in HV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Participant must be 18 to 50 years of age inclusive, at the time of signing
- •the informed consent.
- •2. Participants who are overtly healthy as determined by medical evaluation
- •including medical history, physical examination, laboratory tests, vital signs
- •and cardiac monitoring.
- •3. Body weight within 50*100 kg and body mass index (BMI) within the range
- •18---30 kg/m2 (inclusive).
- •4. Must be Male:
- •Participants must agree to the following during the intervention period and for
- •at least 90 days after the last dose of study intervention:
- •- Refrain from donating sperm.
- •PLUS, either:
- •-Be abstinent from heterosexual intercourse as their preferred and usual
- •- Must agree to use contraception/barrier as detailed below:
- •- Agree to use a male condom
- •-And should also be advised of the benefit for a female partner to use a highly
- •effective method of contraception.
- •5. 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
- •1. History or presence of/significant history of or current cardiovascular,
- •respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or
- •neurological disorders capable of significantly altering the absorption,
- •metabolism, or elimination of drugs; constituting a risk when taking the study
- •intervention or interfering with the interpretation of data
- •2. Personal or family history of cardiomyopathy.
- •3. Abnormal blood pressure as determined by the investigator.
- •4. Symptomatic herpes zoster within 3 months prior to screening.
- •5. Evidence of active or latent tuberculosis (TB) as documented by medical
- •history andvexamination, and TB testing: a positive (not indeterminate)
- •QuantiFERON-TB Gold test.
- •6. Significant allergies to humanized monoclonal antibodies.
- •7. Clinically significant multiple or severe drug allergies, intolerance to
- •topical corticosteroids, or severe post-treatment hypersensitivity reactions
- •(including, but not limited to, erythema multiforme major, linear
- •immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative
- •dermatitis)
- •8. Lymphoma, leukaemia, or any malignancy. Those who are at risk of DNA repair
- •diseases or any family history of DNA repair disease.
- •9. Alanine transaminase (ALT) >1.5x upper limit of normal (ULN).
- •10. Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if
- •bilirubin is fractionated and direct bilirubin <35%).
- •11. Current or chronic history of liver disease or known hepatic or biliary
- •abnormalities (with the exception of Gilbert's syndrome or asymptomatic
- •gallstones).
- •12. QTc >450 msec
- •-The QTc is the QT interval corrected for heart rate according to Bazett*s
- •formula (QTcB), Fridericia*s formula (QTcF), and/or another method, machineread
- •or manually over-read.
- •- The specific formula that will be used to determine eligibility and
- •discontinuation for an individual subject will be QTcF. In other words, several
- •different formulae cannot be used to calculate the QTc for an individual subject
- •and then the lowest QTc value used to include or discontinue the subject from
- •-For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a
- •composite of available values of QTc will be used as specified in the Reporting
- •and Analysis Plan (RAP).
- •13. History of Stevens-Johnson Syndrome.
- •14. Known immunodeficiency.
- •15. Participants with an acute, re-current or chronic infection (e.g.,
- •osteomyelitis), who have been receiving treatment within three months prior to
- •dosing or individuals with an active infection.
- •16. Previous or current history of excessive bleeding or coagulation disorders.
- •17. Previous history of hypertrophic or keloid scarring.
- •18. Any current, clinically significant, known medical condition in particular
- •any existing conditions that would affect sensitivity to cold (such as
- •atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (such as
- •disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia,
- •neuropathy).
- •19. Participants indicating pain tests intolerable at screening. Participants
- •achieving tolerance at >80% of maximum input intensity for cold pressor and
- 另有 2 项未显示
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