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Testing GSK4527363 in healthy individuals and those with systemic lupus erythematosus

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)

Phase 1 Interventional GlaxoSmithKline · NCT06576271

This study is testing a new drug called GSK4527363 in healthy people and those with systemic lupus erythematosus to see how safe it is and how it works in the body.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment142 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Locations27 sites (Scottsdale, Arizona and 26 other locations)
Trial IDNCT06576271 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of GSK4527363 in three groups: healthy participants, participants with active systemic lupus erythematosus (SLE), and healthy individuals of Chinese and Japanese descent. The trial is divided into three parts, with the first part focusing on healthy participants, the second on those with SLE, and the third specifically on healthy participants from Asian backgrounds. Participants will receive either GSK4527363 or a placebo, and their responses will be closely monitored to gather data on the drug's effects.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 to 55 and those with active systemic lupus erythematosus.

Not a fit: Patients who are not of Japanese or Chinese descent may not benefit from the specific focus of this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for patients with systemic lupus erythematosus.

How similar studies have performed: Other studies have shown promise with similar approaches, particularly in evaluating new treatments for systemic lupus erythematosus.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Scottsdale, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusBelimumabFirst time in human studyGSK4527363Healthy participantsImmunogenicityPharmacokineticsSystemic lupus erythematosus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.