Phase 1 Parkinson's 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 all participants:

• People who have read and signed a consent form showing they understand the study, including its risks, before any study activities begin
• Healthy men or women aged between 30 and 89 years old at the time of screening
• People with a body mass index (a measure of body weight relative to height) between 18 and 32
• People whose physical examination shows no additional medically important findings
• People with blood pressure readings within a specific range (systolic between 90–140 and diastolic between 40–90 mmHg), measured lying down and then standing — and whose blood pressure does not drop significantly when standing up
• People with a resting heart rate between 50 and 100 beats per minute, measured lying down and then standing, without a large increase in heart rate upon standing
• People with a body temperature (measured in the ear) between 35.5°C and 37.5°C
• People whose heart trace (ECG) shows no important abnormalities, including a specific heart rhythm measurement within the accepted range for their sex
• People whose blood and urine tests show no important abnormalities, as judged by the study doctor
• Women who are not able to become pregnant — either because of surgery (such as removal of the uterus, fallopian tubes, or ovaries, at least 6 weeks before screening) or because they have been through menopause (no periods for 12 months without another medical cause, confirmed by a hormone test)
• Women who could become pregnant but have a negative pregnancy test at screening and again before the first dose, agree not to donate eggs or try to become pregnant from the time of signing consent until at least 30 days after the last dose, and agree to either remain abstinent or use a condom together with another highly effective contraceptive method (unless in an exclusively same-sex relationship)
• Men who agree not to donate sperm from the time of signing consent until at least 30 days after the last dose, and who agree to use appropriate contraception during that period depending on their partner's situation (confirm specific requirements with trial site)
• People who are willing and able to attend all visits, follow the study plan, and complete all required tests and procedures

Additional criteria for people with Parkinson's disease:

• People with a confirmed diagnosis of Parkinson's disease made by a neurologist or geriatrician between 1 and 10 years before the first dose
• People whose Parkinson's disease shows specific movement-related features as defined by recognised diagnostic guidelines (confirm details with trial site)
• People with a Hoehn and Yahr disease severity score between 1 and 3 (a scale used to measure how advanced Parkinson's disease is)
• People who have not been diagnosed with any other brain-degenerating condition
• People taking levodopa-containing medication who have been on a stable dose for at least 2 months before screening and are able to stop taking it for at least 12 hours before receiving the study drug — they would be able to restart their medication immediately after the study drug is given and assessments are done
• People not taking levodopa-containing medication who are able to remain without that type of treatment throughout the entire study period

Who may not be able to join:

For all participants:

• People who have used immune-suppressing medications (including steroids or certain over-the-counter steroid creams, sprays, or tablets) within the past 60 days before the first dose, unless the study sponsor gives approval
• People who have used coenzyme Q10 supplements within 5 days before the first dose
• People who have received a vaccine within 60 days before the first dose
• People with a known allergy or history of a serious allergic reaction to any ingredient in the study drug
• People who have had a mini-stroke, stroke, or unexplained loss of consciousness within 12 months before screening
• People who test positive for COVID-19 on the day of admission to the clinic, or who have reported experiencing Long COVID at any time before screening (defined as symptoms lasting at least 2 months, usually beginning within 3 months of a COVID-19 infection)
• People with a history of any significant medical condition that the study doctor considers could put them at risk or affect the study results — including serious heart, blood, lung, liver, kidney, digestive, hormonal, or nerve conditions, active cancer within the last 5 years (with some exceptions for certain treated skin cancers), or significant mental health conditions such as severe depression, schizophrenia, or bipolar disorder (confirm specific exceptions with trial site)
• People who have had surgery or been hospitalised within 12 weeks before screening, or who have surgery planned during the study period
• People whose veins are not considered suitable for repeated blood draws or cannula insertion, as assessed by the study doctor
• People with tattoos or scarring in areas that could affect the assessment of injection site reactions, as judged by the study doctor
• People whose kidney function test results fall below the required level for their age and health group (confirm specific thresholds with trial site)
• People whose liver enzyme test results are elevated above acceptable limits (with some exceptions at the study doctor's discretion)
• People whose bilirubin (a liver-related marker in the blood) is above the acceptable limit
• People with any other laboratory result or medical condition that the study doctor considers puts them at risk
• People who have had an active infection requiring antibiotic, antifungal, or antiviral medication within 14 days before the first dose
• People currently enrolled in another clinical study, or who have participated in one within 90 days before screening
• People who regularly drink more than 10 standard alcoholic drinks per week (where one standard drink equals 10 g of pure alcohol — for example, a 285 mL beer, 100 mL wine, or 30 mL spirit)
• People who test positive for alcohol at screening or on the day of clinic admission
• People who test positive for drugs of abuse at screening or on the day of clinic admission
• People who test positive for cotinine (a marker of nicotine/tobacco use) on the day of clinic admission
• People who smoke more than 5 cigarettes (or equivalent) per week, or who are unwilling to stop smoking for 72 hours before check-in and throughout the clinic stay
• People who have used cannabis or THC (including for medical reasons) within 90 days before the first dose, or who are unwilling to stop using it during the study
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
• People with known substance use issues or personal, psychological, or social circumstances that the study doctor believes could affect the study or its results
• People who test positive for Hepatitis B, Hepatitis C, or HIV at screening
• People who have donated blood or had a significant blood loss (more than 500 mL) within 3 months before the first dose, or who have received a blood transfusion within 1 year before the first dose
• People who, for any other reason, the study doctor considers unsuitable for the study

Additional exclusion criteria for people with Parkinson's disease:

• People with Parkinson's disease who have used antibiotics within 30 days before the first dose
• People with Parkinson's disease who have been using prebiotic or probiotic supplements within 30 days before the first dose (may be permitted in some cases — confirm with trial site)
• People who have previously used biologic therapies targeting beta-amyloid or tau protein (treatments associated with Alzheimer's-type research)
• People who have had brain surgery for Parkinson's disease, focused ultrasound treatment, or any nerve stimulation procedures at any time
• People who have had three or more unexplained falls within 12 months before the first dose
• People with a history of prostate cancer found within the prostate (in situ)
• People with Parkinson's disease who also have other significant medical conditions, including serious heart, blood, lung, liver, kidney, digestive, hormonal, or nerve conditions (other than Parkinson's itself), or significant mental health conditions — though people with stable conditions may be considered at the study doctor's discretion in consultation with the sponsor
• People with a history of cancer within the last 5 years (with some exceptions for certain treated skin cancers)
• People who have had non-routine or emergency surgery or hospitalisation within 12 weeks before screening, or who have surgery planned during the study

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