NCT05882695

Who might be able to join this trial:

General (Healthy Volunteer) Group:

• You are between 18 and 55 years old
• You are in good general health with no significant medical history
• Your routine blood and lab test results are within normal or near-normal range
• Your Body Mass Index (BMI) is between 18 and 32
• You are willing and able to use an appropriate form of contraception (as required by local rules)
• You are able to read, understand, and sign a consent form agreeing to take part

ALS Patient Group:

• You are between 18 and 80 years old
• You have a specific ALS risk score measured using the TRICALS scoring system (confirm with trial site)
• You are on a stable dose of your current standard ALS treatment
• You are willing and able to use an appropriate form of contraception (as required by local rules)
• You are able to read, understand, and sign a consent form agreeing to take part

Who may not be able to join:

General (Healthy Volunteer) Group:

• You have any physical or mental health condition that would prevent you from completing the study
• You have a known heart condition
• You have been diagnosed with cancer in the past 5 years, or currently have cancer
• You have had a serious infection within the past month
• You have been acutely unwell within the 30 days before the study starts
• You have had surgery, a broken bone, or a significant muscle or joint injury in the past 3 months
• You have a history of suicidal thoughts or suicidal behaviour
• You currently smoke or use any nicotine-containing products (such as patches, vapes, or chewing gum)
• You have tested positive for HIV, hepatitis B, or hepatitis C
• Your blood pressure or heart rate falls outside of the acceptable range set by the trial (confirm with trial site)
• You have an abnormal heart rhythm, an abnormal heart electrical reading (ECG), or a specific heart measurement (QTcF) above the allowed level (confirm with trial site)
• You have taken any prescription, over-the-counter, or herbal medicines in the past 7 days
• You have received any vaccines in the past 14 days
• You have taken part in another clinical trial involving an investigational medicine in the past 30 days
• You have donated blood in the past 30 days
• You have donated plasma in the past 7 days
• You are currently pregnant or breastfeeding
• You have a positive drug test, or have recently consumed alcohol or caffeine-containing products, or are following a diet or lifestyle that significantly affects your metabolism (confirm with trial site)

ALS Patient Group:

• You have any physical or mental health condition that would prevent you from completing the study
• You have a known heart condition
• You have been diagnosed with cancer in the past 5 years, or currently have cancer
• You have had a serious infection within the past month
• You have been acutely unwell within the 30 days before the study starts
• You have a history of suicidal thoughts or suicidal behaviour
• You currently smoke or use any nicotine-containing products (such as patches, vapes, or chewing gum)
• You have another condition affecting the brain or nervous system (confirm with trial site)
• You require a breathing machine or supplemental oxygen to support your breathing
• You have tested positive for HIV, hepatitis B, or hepatitis C
• Your blood pressure or heart rate falls outside of the acceptable range set by the trial (confirm with trial site)
• You have an abnormal heart rhythm, an abnormal heart electrical reading (ECG), or a specific heart measurement (QTcF) above the allowed level (confirm with trial site)
• You have received any vaccines in the past 14 days
• You have taken part in another clinical trial involving an investigational medicine in the past 30 days
• You have donated blood in the past 30 days
• You have donated plasma in the past 7 days
• You are currently pregnant or breastfeeding
• You are considered otherwise unfit to take part for any other reason (confirm with trial site)

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