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临床试验/NCT05590338
NCT05590338已完成1 期

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of a Single Intravenous Dose of GSK1070806 Administered to Healthy Male and Female Caucasian, Chinese and Japanese Participants Aged 18 to 65 Years of Age Inclusive

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年11月4日最近更新:
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适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
38
试验地点
1
主要终点
Part A: Serum GSK1070806 area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-∞])
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

In Part A the participants and investigators will be masked. In Part B there will be no masking.

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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
  • •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

研究组 & 干预措施

Part A: GSK1070806

Experimental

Participants in Part A will receive single dose of GSK1070806 intravenous (IV) infusion

干预措施: GSK1070806 (Drug)

Part B: GSK1070806

Experimental

Participants in Part B will receive single dose of GSK1070806 IV bolus

干预措施: GSK1070806 (Drug)

Part A: Placebo

Placebo Comparator

Participants in Part A will receive single dose of placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Part A: Serum GSK1070806 area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-∞])

时间窗: Up to Week 24

Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

时间窗: Up to Week 24

Part A: Serum GSK1070806 area under the concentration-time curve from time zero to the last quantifiable time (AUC(0-t))

时间窗: Up to Week 24

Part A: Maximum observed serum concentration (Cmax) of GSK1070806

时间窗: Up to Week 24

次要结局

  • Part B: Number of participants with AEs and SAEs(Up to Week 32)
  • Part A: Total IL-18 concentrations in serum(Up to Week 24)
  • Part B: Total IL-18 concentrations in serum(Up to Week 32)
  • Part B: Number of participants with ADA formation(Up to Week 32)
  • Part A: Number of participants with anti-drug antibody (ADA) formation(Up to Week 24)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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