A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
A Phase 1, First-time-in-human, Four-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of GSK4527363, how the body handles it, and how it affects the body and immune system. It is for healthy adults, including groups of Chinese and Japanese adults, adults with active lupus, and adults with lung disease linked to connective tissue disease.
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), healthy participants of Chinese and Japanese descent (Part C), and participants with interstitial lung disease associated with connective tissue disease (Part D)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Parts A and C: Be 18–55 years old and healthy based on medical exams, blood tests, and heart checks.
- Part C: For the Japanese group, be born in Japan and have 2 Japanese parents and 4 Japanese grandparents. Have lived outside Japan for less than 10 years.
- Part C: For the Chinese group, be born in mainland China, Hong Kong, or Taiwan and have 2 Chinese parents and 4 Chinese grandparents. Have lived outside these places for less than 10 years.
- Parts A and C: Be male or a female who cannot become pregnant.
- Part B: Be 18–65 and have a confirmed diagnosis of lupus, a disease in which the immune system attacks the body.
- Part D: Be 18–65 and have a confirmed connective tissue disease and related lung disease shown on a detailed lung scan. Take a stable dose of medicine for the lung or connective tissue disease.
- All parts: Weigh at least 45 kg (about 99 pounds). Have a body mass index (BMI), a measure of weight compared with height, of 18–32.
- Parts B and D: Men and women may join and must be able to sign a form agreeing to take part.
Who can't join
- All parts: Certain infections, including active or inactive tuberculosis (TB), HIV, or certain positive hepatitis B or C tests. Rules for recent or ongoing infections differ by study part.
- All parts: Certain high liver blood test results or recent live vaccines. Some parts also rule out planned live vaccines.
- Parts A and C: A history of certain heart, lung, liver, kidney, gut, hormone, blood, or nerve diseases; abnormal blood pressure; or certain abnormal heart rhythm test results. Part B also has a heart rhythm test limit.
- Parts A and C: Cancer history, a strong family history of cancers linked to a weakened immune system, certain severe drug allergies, trouble tolerating steroid skin creams, or past anaphylaxis—a severe allergic reaction.
- Parts B and D: Serious uncontrolled illnesses outside the study disease, certain cancers now or within the past 5 years, a confirmed serious brain infection called PML, or new or worsening unexplained nerve symptoms. Some treated early cancers are allowed.
- Part B: A severe lupus flare during screening that needs treatment right away.
- Part D: Lupus, lung disease not linked to connective tissue disease, a breathing test result of 45% or less of the expected value, or high blood pressure in the arteries of the lungs.
- Part D: Major surgery within 3 months before screening or planned during the study, or a past or planned major organ or bone marrow transplant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion criteria: For Part A and Part C (Healthy Participants): * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (vital signs and 12-lead ECG) * Part C only: Be of Japanese (Cohort C1) or Chinese (Cohort C2) ancestry i. Born in Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2); and ii. Descendent of 2 ethnic Japanese (Cohort C1) or Chinese (Cohort C2) parents and 4 ethnic grandparents; and iii. Have lived outside Japan (Cohort C1) or China mainland, Hong Kong or Taiwan (Cohort C2) for less than 10 years at the time of screening * Body weight greater than or equals to (\>=) 45 kilograms (kg) * Body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m\^2) (inclusive) * Male or female of non-childbearing potential For Part B (SLE participants): * 18 to 65 years of age inclusive, at the time of signing the informed consent form * Documented clinical diagnosis of SLE according to the (European alliance of associations of rheumatology \[EULAR\]/ American College of Rheumatology \[ACR\] SLE classification criteria) * Body weight \>= 45 kg * BMI within the range 18-32 kg/m\^2 (inclusive) * Male or female * Capable of giving signed informed consent For Part D (CTD-ILD Participants) * Participants must be 18 to 65 years of age, at the time of signing the informed consent form * Documented clinical diagnosis of specific Connective Tissue Diseases in accordance with internationally recognised classification criteria * Documented clinical diagnosis of interstitial lung disease (ILD) as determined by historical High-resolution computed tomography (HRCT) * Participants must be on a stable dose of therapy to manage ILD and/or underlying connective tissue disease (CTD) * Body weight \>= 45 kg * BMI within the range 18-32 kg/m\^2 (inclusive) * Male or female * Capable of giving signed informed consent Exclusion criteria: For Part A and Part C (Healthy Participants): * History or presence or cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders * A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug * Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks before dosing * Symptomatic herpes zoster within 3 months prior to screening * Have a history of malignancy, or a strong family history of malignancies related to immunosuppression * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions * Abnormal blood pressure * Evidence of active or latent Tuberculosis (TB) * Alanine transaminase (ALT) \>=1.1\* Upper limit of normal (ULN) * Total bilirubin \>1.0\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>=1.5\*ULN as long as direct bilirubin is less than or equal to (\<=)1.5\*ULN * Presence of Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention * Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention * Positive Human immunodeficiency virus (HIV) antibody test at screening * Prior medical history of anaphylaxis * QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 milliseconds (msec) * Live vaccine(s) within 30 days before the dosing day or plans to receive such vaccines during the study For Part B (SLE participants): * Any acute, severe lupus related flare during the Screening Period that needs immediate treatment * Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE which, in the opinion of the principal investigator (PI), could confound the results of the clinical study or put the participant at undue risk * Have an acute or chronic infection requiring management as follows: i. Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria ii. A serious infection requiring treatment with antibiotics and/or hospitalization if the last dose of antibiotics or the hospital discharge date was within 60 days of the first day of dosing (Day 1). Prophylactic anti-infective treatment is allowed * Evidence of active or latent TB * Confirmed Progressive Multifocal Leukoencephalopathy (PML) or unexplained new-onset or deteriorating neurologic signs and symptoms * ALT \>2\*ULN * Total bilirubin \>1.5\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5\*ULN as long as direct bilirubin is \>1.5\*ULN * Presence of HBsAg and/or HBcAb at screening or within 3 months prior to first dose of study intervention * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention * Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention * History or positive test at Screening for HIV * QTcF \>450 msec * Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, Cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years * Live or live-attenuated vaccine(s) within 30 days prior to Screening For Part D Participants: * A diagnosis of: ILD other than CTD-ILD and/or SLE * FVC \<= 45% predicted at Screening Pulmonary arterial hypertension, as determined by the Investigator, prior to Day 1 * Major surgery (including joint surgery) within 3 months prior to Screening or planned during the duration of the study * Previous or planned major organ transplant (e.g. heart, lung, kidney, liver) or bone marrow transplant (e.g. autologous stem cell transplant) * Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to CTD-ILD (i.e., cardiovascular, metabolic, hematologic, GI, hepatic, renal, neurological, psychiatric, malignancy, or infectious diseases) which, in the opinion of the PI, could confound the results of the clinical study or put the participant at undue risk * Have an acute or chronic infection including requiring management * Evidence of active or latent TB * Confirmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms * ALT \>2\*ULN * Total bilirubin \>1.5\*ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5\*ULN as long as direct bilirubin is \>1.5\*ULN * Presence of HBsAg and/or HBcAb at screening or within 3 months prior to first dose of study intervention * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention * Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention * History or positive test at Screening for HIV * Solid or hematological malignancy or a history of malignancy (in the past 5 years) of except for basal cell or squamous cell in situ skin carcinomas, CIN or carcinoma in situ of the cervix that have been resected with no evidence of metastatic disease for 3 years * Live or live-attenuated vaccine(s) within 30 days prior to Screening or plans to receive such vaccines during the Screening period or during the clinical study
Study sites (6)
AZ
- GSK Investigational Site · Scottsdale, AZ 85260More trials in Scottsdale
CO
- GSK Investigational Site · Aurora, CO 80045US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comChristopher Striebich · Principal investigatorMore trials in Aurora
NV
- GSK Investigational Site · Las Vegas, NV 89154US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comWalter Chatham · Principal investigatorMore trials in Las Vegas
OH
- GSK Investigational Site · Columbus, OH 44109US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comJudith Lin · Principal investigatorMore trials in Columbus
OK
- GSK Investigational Site · Oklahoma City, OK 73104More trials in Oklahoma City
TX
- GSK Investigational Site · Dallas, TX 75390More trials in Dallas