Chronic pain diseases. Chronic pain diseases
Conditions
Interventions
GSK3858279, 3 mg/kg. single dose, once per study period or Placebo single dose,
once per study period. Participants will receive up to 2 single doses of
GSK3858279.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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 lifestyle OR: - 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.
Exclusion criteria
Exclusion criteria: 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 450 msec NOTES: -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 the trial. -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 electrical pain tests are to be excluded. If pressure pain test tolerance is >80% of maximum input intensity they may be enrolled as per PI judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - UVB heat pain detection (oC) - Cold pressor time to intolerable pain threshold (secs) - Electrical pain tolerance threshold (mA) - single stimulus | — |
Countries
Netherlands
Outcome results
None listed