a study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamic of gsk1070806 after a single intravenous dose in healthy male and female caucasian, chinese and japanese participants aged 18 to 65 years of age inclusive

Conditions: Dermatitis, Atopic

Summary: this study is divided into two parts: part a of the study is double blinded, randomized, placebo-controlled and aims to assess the safety, tolerability, pharmacokinetics (pk) and pharmacodynamic (pd) effect of a single intravenous (iv) infusion dose of gsk1070806 when administered to healthy participants of japanese, chinese and european/caucasian ancestry. part b of the study is an open label single cohort arm to assess the safety, tolerability, pk and pd effect of a single iv bolus low dose of gsk1070806 in healthy participants of european/caucasian ancestry.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring \[12-lead electrocardiogram (ecgs)\] * between 18 and 65 years of age inclusive, at the time of signing the informed consent * body weight within the range 45 - 100 kilograms (kg) and body mass index (bmi) within the range 18-32 kilogram/meter square (kg/m\^2) (inclusive) * a female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: * is a woman of non-childbearing potential (woncbp) or * is a woman of childbearing potential (wocbp) and using a contraceptive method that is highly effective \[with a failure rate of less than 1 percent (\<1%) per year\], with low user dependency * capable of giving signed informed consent * participants of japanese ancestry are eligible based on meeting all of the following: * healthy male and female participants born in japan * descendants of four ethnic japanese grandparents and two ethnic japanese parents * have lived outside japan for less than 10 years at the time of screening * chinese participants are eligible based on meeting all of the following: * healthy male and female participants born in mainland china, hong kong, macau or taiwan * descendants of four ethnic chinese grandparents and two ethnic chinese parents * have lived outside mainland china, hong kong, macau or taiwan for less than 10 years at the time of screening * participants of caucasian/european ancestry are eligible if they self-identify to be of caucasian/european ancestry and have 2 parents of caucasian/european ancestry and 4 grandparents of caucasian/european ancestry exclusion criteria: * history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunological, metabolic, musculoskeletal 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 * personal or family history of cardiomyopathy * known varicella, herpes zoster, or other severe viral infection within 6 weeks of anticipated dosing on day 1. or history of recurrent herpes reactivation in the past 2 years * evidence of active or latent tuberculosis (tb) as documented by medical history, examination, and tb testing with a positive (not indeterminate) quantiferon test * history or evidence of clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, anaphylaxis, erythema multiforme major, linear immunoglobulin a (iga) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis) * lymphoma, leukemia, or any malignancy except for basal cell carcinomas of the skin that have been resected with no evidence of metastatic disease for 5 years * alanine transaminase (alt) greater than (\>) 1.5x upper limit of normal (uln) * total bilirubin \>1.5xuln (isolated bilirubin \>1.5xuln is acceptable if bilirubin is fractionated and direct bilirubin \<35%) * current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones or previous uncomplicated cholecystectomy more than 3 months ago) * corrected qt using bazett's formula (qtcb) (bazett) or corrected qt using fridericia's formula (qtcf) (fridericia) interval \>450 milli second (msec) * history of stevens johnson syndrome * known immunodeficiency * previous or current history of bleeding diathesis * intended use of over the counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to dosing until final follow-up visit * live vaccine(s) or plans to receive such vaccines within 2 months of dosing until final follow-up visit * participation in the study would result in loss of blood or blood products in excess of 500 milli liter (ml) within 3 months * current enrollment or past participation in any other clinical study involving an investigational study intervention or any other type of medical research within the last 30 days, 5 half-lives or twice the duration of the known pharmacological/biological effect from the last dosing before dosing day in the current study * coronavirus strain 19 (covid-19) (severe acute respiratory syndrome - coronavirus-2 (sars cov-2)): * has had covid-19 infection within 4 weeks of the initial screening visit * positive coronavirus test (covid-19: sars-cov-2 polymerase chain reaction (pcr) or rapid antigen test) at initial screening * signs and symptoms suggestive of covid-19 (i.e., fever, cough, etc.) within 14 days of initial screening known covid-19-positive contacts within 14 days of initial screening, at any time during the screening period, or within 14 days of dosing on day 1 * active substance abuse or a history of substance abuse within 6 months prior to the initial screening visit. substance abuse including cannabis is also prohibited during the study

Keywords: immunoglobulin g1 (igg1) antibody interleukin-18 (il-18) gsk1070806 218841