Phase 1 Alzheimer's Disease 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:

• Adults between 18 and 64 years old (inclusive) who are generally healthy, both male and female.
• People whose body weight falls within a healthy range for their height (BMI between 18.0 and 30.0); men must weigh at least 50 kg and women at least 45 kg.
• People with no significant health problems, as confirmed by a physical check-up, heart tracing (ECG), vital signs, and routine blood and lab tests.
• Male participants who have a female partner who could become pregnant must either be permanently sterile (e.g., vasectomy with confirmed results), agree to use highly effective contraception (condom plus their partner using a cervical cap, diaphragm with spermicide, or an intrauterine device) from the day before the study starts until 90 days after the last dose, or abstain from sex during that same period.
• Male participants must agree not to donate sperm from the day before the study starts until 90 days after the last dose.
• Female participants who could become pregnant must either be permanently sterile (e.g., hysterectomy, removal of both fallopian tubes or ovaries, or tubal ligation performed at least 6 weeks before the first dose), use highly effective contraception (male partner using a condom plus the female participant using a cervical cap or diaphragm with spermicide, or an intrauterine device) starting at least 30 days before the first dose and continuing for 90 days after the last dose, have a vasectomised sole sexual partner with confirmed sterility, or abstain from sex from at least 30 days before the first dose until 90 days after the last dose.
• Female participants who have gone through menopause must have had no periods for at least 2 years, or no periods for 12 months with a hormone test confirming menopause.
• People who are willing and able to give written consent, follow the study requirements, and communicate clearly with the research team.

Who may not be able to join:

• Women who are pregnant, breastfeeding, or who have a positive pregnancy test at any point before the study drug is given.
• People with a history of any serious illness, including conditions affecting the brain, heart, blood, mental health, liver, stomach or gut, lungs, hormones, immune system, or kidneys, or any cancer diagnosis within the past 5 years.
• People who show certain abnormalities on their heart tracing (ECG) at the screening check.
• People whose blood pressure falls outside the acceptable range (systolic between 90–140 mmHg and diastolic between 50–90 mmHg) at screening.
• People with a history of heart or blood vessel problems, such as irregular heartbeat, high or low blood pressure, chest pain, heart attack, or heart failure.
• People whose blood tests suggest the liver or kidneys are not functioning within acceptable limits at screening.
• People who have had a significant illness or infection in the 14 days before the study begins.
• People with current or recent (within 3 months) stomach or gut conditions, including ulcers, acid reflux, gastritis, or gut surgery that could affect how the study drug is absorbed.
• People who have had major surgery within 4 weeks before the first dose of the study drug.
• People who have donated a significant amount of blood or plasma recently (250 mL or more within 8 weeks, 500 mL or more within 12 weeks, or any plasma donation within 2 weeks before the study drug is given).
• People who are unable to swallow oral medication.
• People who are unable to tolerate having blood drawn through a needle in their vein.
• People who have used any tobacco or nicotine products within the 6 months before screening.
• People who regularly consume more than 200 mg of caffeine per day (roughly more than 2 cups of coffee) over the past 6 months.
• People who drink more than one standard alcoholic drink per day on average over the past 6 months.
• People who have misused drugs or alcohol within the past 6 months.
• People with a history of a significant allergic reaction to any drug.
• People who test positive for hepatitis C, hepatitis B, or HIV.
• People who test positive for recreational drugs or alcohol at screening.
• People who have taken part in another clinical trial and received an experimental drug within 4 weeks before this study begins.
• People who have taken any prescription medicines, over-the-counter medicines, herbal products, or dietary supplements within 2 weeks (or longer, depending on the specific medicine) before the study drug is given.
• People who have received protein- or antibody-based treatments (such as growth hormones or monoclonal antibodies) within 3 months before the study drug is given, or who have received a flu or COVID-19 vaccine within 4 weeks before the first dose.
• People who have used hormonal contraceptives (taken by mouth, injection, or implant) within 14 days before the study drug is given.
• For one part of the study (called the MAD part only): people who have ever had certain serious thoughts about suicide, made any suicide attempt, or shown preparatory behaviour, as assessed by a standard clinical questionnaire; or people who have had any passive wishes to be dead or general thoughts of suicide in the past 12 months. The trial site investigator may also exclude anyone they consider to be at serious risk.
• Anyone the investigator considers unsuitable to participate for any other reason.

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