Phase 1 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For healthy volunteers (Parts A and C):

• People aged 18 to 55 years old at the time of signing consent
• People confirmed to be in good general health through medical history, physical check-up, blood tests, and heart monitoring
• People weighing at least 45 kilograms
• People with a body mass index (a measure of body weight relative to height) between 18 and 32
• Male, or female without the ability to become pregnant
• For Part C only: People of Japanese ancestry (Cohort C1) or Chinese ancestry (Cohort C2), born in Japan or China/Hong Kong/Taiwan respectively, with both parents and all four grandparents of that same ethnicity, who have lived outside their home country for fewer than 10 years at the time of screening

For people with lupus (SLE) (Part B):

• People aged 18 to 65 years old at the time of signing consent
• People with a formally documented diagnosis of Systemic Lupus Erythematosus (SLE) according to recognised international classification standards
• People weighing at least 45 kilograms
• People with a body mass index between 18 and 32
• Male or female
• People who are able to give signed informed consent

For people with connective tissue disease-related lung disease (CTD-ILD) (Part D):

• People aged 18 to 65 years old at the time of signing consent
• People with a formally documented diagnosis of a connective tissue disease, according to recognised international classification criteria
• People with a formally documented diagnosis of interstitial lung disease (scarring or inflammation of the lungs) confirmed by a specific type of CT scan
• People who have been on a stable treatment dose to manage their lung disease and/or underlying connective tissue disease
• People weighing at least 45 kilograms
• People with a body mass index between 18 and 32
• Male or female
• People who are able to give signed informed consent

Who may not be able to join:

For healthy volunteers (Parts A and C):

• People with a history of, or current, heart, lung, liver, kidney, digestive, hormonal, blood, or nervous system conditions
• People with a history of repeated infections, or who have been treated for a long-term infection within the 3 months before their first dose
• People with any current infection that has not fully cleared up at least four weeks before dosing
• People who have had a shingles flare-up within 3 months before screening
• People with a personal history of cancer, or a strong family history of cancers linked to immune suppression
• People with significant or severe allergies to multiple medicines, intolerance to steroid creams, or a history of severe reactions after medical treatment
• People with abnormal blood pressure readings
• People with signs of active or latent (hidden/inactive) tuberculosis (TB)
• People with certain abnormal liver blood test results (specific levels will be assessed by the trial site)
• People with abnormal bilirubin levels in the blood, unless they have a specific condition called Gilbert's syndrome and their results meet certain criteria (confirm with trial site)
• People who test positive for Hepatitis B at screening or within 3 months before their first dose
• People who test positive for Hepatitis C at screening or within 3 months before their first dose
• People who test positive for HIV at screening
• People with a prior history of a severe allergic reaction called anaphylaxis
• People whose heart rhythm measurement (a specific interval called QTcF) is above a certain threshold on their heart tracing (ECG)
• People who have received a live vaccine within 30 days before dosing, or who plan to receive one during the study

For people with lupus (SLE) (Part B):

• People experiencing a severe lupus flare-up during the screening period that needs immediate treatment
• People with significant unstable or uncontrolled health conditions unrelated to SLE, which in the trial doctor's opinion could affect results or pose undue risk
• People currently on long-term suppressive treatment for infections such as pneumocystis, cytomegalovirus, herpes, or certain bacterial infections, or who have been hospitalised or received antibiotics for a serious infection within 60 days before the first dose
• People with signs of active or latent tuberculosis (TB)
• People with a confirmed or suspected serious brain condition called Progressive Multifocal Leukoencephalopathy (PML), or unexplained new or worsening neurological symptoms
• People with certain abnormal liver blood test results (specific levels will be assessed by the trial site)
• People with abnormal bilirubin levels, unless they have Gilbert's syndrome and meet specific criteria (confirm with trial site)
• People who test positive for Hepatitis B at screening or within 3 months before their first dose
• People who test positive for Hepatitis C at screening or within 3 months before their first dose
• People who test positive for HIV, or have a history of HIV
• People with a heart rhythm measurement (QTcF) above a certain threshold on their ECG
• People with a current or recent (within the past 5 years) history of cancer, with some limited exceptions for certain early-stage skin or cervical conditions that have been fully treated (confirm with trial site)
• People who have received a live or live-attenuated vaccine within 30 days before screening

For people with connective tissue disease-related lung disease (CTD-ILD) (Part D):

• People whose lung disease has been diagnosed as a type of ILD other than CTD-ILD, or who have SLE as their primary diagnosis
• People whose lung capacity (a breathing test measurement called FVC) is at or below 45% of the expected normal level at screening
• People with pulmonary arterial hypertension (high blood pressure in the lungs), as determined by the trial doctor, before the first dose
• People who have had major surgery within 3 months before screening, or who plan to have major surgery during the study
• People who have previously had, or are planned to have, a major organ transplant (such as heart, lung, kidney, or liver) or a bone marrow transplant
• People with significant unstable or uncontrolled health conditions unrelated to CTD-ILD, which in the trial doctor's opinion could affect results or pose undue risk
• People with an active or ongoing infection requiring treatment
• People with signs of active or latent tuberculosis (TB)
• People with confirmed or suspected PML, or unexplained new or worsening neurological symptoms
• People with certain abnormal liver blood test results (specific levels will be assessed by the trial site)
• People with abnormal bilirubin levels, unless they have Gilbert's syndrome and meet specific criteria (confirm with trial site)
• People who test positive for Hepatitis B at screening or within 3 months before their first dose
• People who test positive for Hepatitis C at screening or within 3 months before their first dose
• People who test positive for HIV, or have a history of HIV
• People with a current or recent (within the past 5 years) history of cancer, with some limited exceptions for certain early-stage skin or cervical conditions that have been fully treated (confirm with trial site)
• People who have received a live or live-attenuated vaccine within 30 days before screening, or who plan to receive one during the screening period or the study

Important: Always verify eligibility with the trial site directly before applying.