Dermatitis, Atopic Clinical Trial
Official title:
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
Verified date | April 2024 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | February 7, 2024 |
Est. primary completion date | July 12, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Cypress | California |
United States | GSK Investigational Site | Las Vegas | Nevada |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part A: Serum GSK1070806 area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-8]) | Up to Week 24 | ||
Primary | Part A: Serum GSK1070806 area under the concentration-time curve from time zero to the last quantifiable time (AUC(0-t)) | Up to Week 24 | ||
Primary | Part A: Maximum observed serum concentration (Cmax) of GSK1070806 | Up to Week 24 | ||
Primary | Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to Week 24 | ||
Secondary | Part B: Number of participants with AEs and SAEs | Up to Week 32 | ||
Secondary | Part A: Total IL-18 concentrations in serum | Up to Week 24 | ||
Secondary | Part B: Total IL-18 concentrations in serum | Up to Week 32 | ||
Secondary | Part A: Number of participants with anti-drug antibody (ADA) formation | Up to Week 24 | ||
Secondary | Part B: Number of participants with ADA formation | Up to Week 32 |
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