Phase 1 Motor Neurone 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:

• Adults aged 18 to 55 years (inclusive) who are considered generally healthy, either male or female.
• Female participants must be of non-childbearing potential, meaning they have had a sterilisation procedure (such as tubal ligation, removal of both fallopian tubes, hysterectomy, or removal of both ovaries) at least 6 months before the first dose, or they are postmenopausal with no menstrual period for at least 1 year before the first dose and have hormone levels consistent with menopause.
• Male participants must agree to follow the trial's specific contraception guidelines and to avoid donating sperm until at least 90 days after the last dose.
• People who have not smoked or used any nicotine-containing products for at least 3 months before the first dose, based on their own report.
• People whose body weight falls within a healthy range, specifically a Body Mass Index (BMI) between 18.0 and 32.0 (confirm with trial site).
• People who are medically healthy with no significant medical history, and whose blood pressure, liver function, and kidney function results all fall within acceptable ranges at the screening visit.
• People whose heart tracing (ECG) shows no significant abnormalities at screening, including a normal heart rhythm and specific measurements of electrical activity within the acceptable ranges set by the trial.
• People who understand the trial procedures and are willing and able to follow the study requirements.

Who may not be able to join:

• People who have a significant mental health condition or are considered to have serious emotional difficulties at the time of screening or during the study.
• People who have a history of, or currently have, a clinically significant medical or psychiatric condition, as assessed by the trial doctor.
• People who have had any illness that, in the trial doctor's opinion, could affect the study results or add risk to their participation.
• People with a history of alcohol or drug misuse in the 2 years before the first dose.
• People who have had an allergic or unusual reaction to the study drug, its ingredients, or to antihistamines.
• People who have an allergy to adhesive bandages, dressings, or medical tape.
• Females who are of childbearing potential.
• Females who test positive for pregnancy at the screening visit or at check-in, or who are currently breastfeeding.
• People who test positive for drugs in their urine or alcohol in their blood at the screening visit or check-in.
• People who test positive for HIV, hepatitis B, or hepatitis C at the screening visit.
• People who are unable to avoid taking any medications (including prescription, non-prescription, herbal, or vitamin supplements) from 14 days before the first dose, or certain medications known to affect how drugs are processed by the body from 28 days before the first dose, or medications known to affect heart rhythm from 14 days (or longer, depending on the medication) before the first dose.
• People who have followed a diet incompatible with the trial's required diet in the 30 days before the first dose, in the trial doctor's opinion.
• People who have donated blood or experienced significant blood loss within 56 days before the first dose.
• People who have donated plasma within 7 days before the first dose.
• People who have participated in another clinical trial within 90 days before the first dose (calculated from the last blood draw or dose in the previous trial, whichever was later).
• People excluded for any other reason determined by the trial doctor.

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