Phase 1 Multiple Sclerosis Trial, Recruiting

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

Who might be able to join this trial:

• Adult males aged 18 to 55 years who are non-smokers or only occasional smokers (fewer than 10 cigarettes or equivalent per week), and who are willing to not smoke while staying at the clinic
• People with a body weight of at least 55 kg and a BMI between 18.0 and 32.0
• People who are in good general health, with no significant illness, infection, or medical or surgical procedure in the 4 weeks before the study drug is given, and no planned surgery or hospital stay during the study
• People with no significant history of serious conditions affecting the heart, brain, lungs, kidneys, liver, hormones, blood, immune system, digestive system, or mental health
• People who are not sexually active with a female partner who could become pregnant, or who are willing to use approved contraception (a condom used together with their female partner's hormonal contraception or an intrauterine device) from the time of dosing until 90 days after
• People who have had a vasectomy at least 3 months before dosing and are willing to use a condom until the study ends
• People who do not have sexual intercourse as a regular and preferred lifestyle choice
• People willing to not donate sperm for 90 days after receiving the study drug
• People willing to receive the study drug by injection into the skin of the abdomen or into the muscle of the buttock area
• People who are willing and able to give written consent to participate after having the study explained to them

Who may not be able to join:

• People with any significant abnormal findings on physical examination at the screening visit or the day before dosing
• People with significantly abnormal blood test results, or who test positive for HIV, hepatitis B, or hepatitis C at screening
• People who are prone to skin rashes or irritation, have a recurring skin condition such as eczema that could affect the injection site, or have any abnormal skin in the planned injection area (as assessed by the investigator)
• People with any history of cancer or tumour growth
• People with a history of significant allergic reactions to any medicine or to any ingredient used in the study drug formulations (such as severe drug reactions, anaphylaxis, angioedema, or hypersensitivity)
• People with elevated liver enzyme or bilirubin levels (more than 1.5 times the upper limit of normal) at screening or the day before dosing
• People with reduced kidney function below a certain level, as measured by a standard calculation, at screening or the day before dosing
• People with significant heart rhythm abnormalities on an ECG, or abnormal blood pressure or heart rate readings at screening or the day before dosing
• People with a history of alcohol abuse in the past year, or regular alcohol use exceeding 14 units per week in the past 6 months, or a positive alcohol test at screening or the day before dosing
• People with a history of drug abuse in the past year, or a positive drug test at screening or the day before dosing
• People with an underlying physical or psychological condition (for example, active depression) that the investigator believes would make it difficult to complete the study — note that mild depression or anxiety that fully resolved at least 6 months before screening may be acceptable
• People who have used certain medications within specified timeframes before dosing, including depot injections or implants within 3 months, strong enzyme-affecting drugs within 30 days, prescription medicines within 14 days, any vaccine within 7 days, over-the-counter medicines within 7 days (with the exception of occasional paracetamol up to 2 g/day), natural health products or supplements within 7 days, anaesthetic agents within 24 hours, or blood-thinning medications from 15 days before dosing to 6 weeks after dosing
• People who have taken part in another clinical trial involving a drug or device within 30 days before dosing, or involving a biological product within 90 days before dosing, or who are currently in another study
• People who have donated plasma within 7 days before dosing, or donated or lost 500 mL or more of blood within 30 days before dosing
• People who, for any reason in the investigator's judgement, would not be suitable to participate in the study

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