Phase 1 Peripheral Arterial 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:

• People who have been fully informed about the study and are willing to sign a consent form before any procedures begin.
• Healthy men and women aged 18 to 55 years (inclusive) at the time of signing the consent form.
• People with a body mass index (BMI) between 18 and 32, and a body weight between 45 and 120 kg, at the time of the screening visit.
• People who have smoked fewer than 10 cigarettes (or an equivalent amount of nicotine products) per month in the 6 months before screening, and who agree not to use tobacco or nicotine products during the study.
• People who are generally in good health, or whose minor health findings are considered not medically significant by the study doctor, based on their medical history, physical check-up, vital signs, heart tracing (ECG), and blood tests at screening and admission.
• Women who could become pregnant must not be pregnant or breastfeeding, and must agree to use highly effective birth control methods — and avoid egg donation or collection — from the screening period until 3 months after the last dose of study treatment. Their male partner must also use condoms during this period.
• Women who cannot become pregnant must either have gone through natural menopause (no periods for at least 12 months in a row, confirmed by a specific hormone blood test) or have had a surgical procedure such as removal of both ovaries, both fallopian tubes, the uterus, or both tubes tied, at least 3 months before taking any study drug.
• Men who are able to father children must agree not to try to father a child, not to donate sperm, and to use effective contraception from the screening period until 3 months after the last dose of study treatment. Their female partner must also use a highly effective contraceptive method during this period.
• Men (including those who have had a vasectomy) whose partner is pregnant must agree to use a condom from the screening period until 3 months after the last dose of study treatment.
• People who are able to communicate clearly with the study team and are willing and able to follow all study requirements.

Who may not be able to join:

• People who have difficulty with blood draws from a vein, or who have a history of fainting at the sight of blood or needles.
• People who have a known or suspected allergy, sensitivity, or intolerance to any ingredient in the study drugs (CG-0255 Besylate or Plavix®), or to similar medications.
• People who took part in another clinical trial involving a drug or medical device within 30 days (or longer, depending on the drug) before the first dose, or a trial involving a biological product within 90 days before the first dose, or who are currently in another clinical study.
• People who have had ongoing or unresolved digestive problems (such as indigestion, acid reflux, stomach bleeding, or ulcers) in the past 6 months, or who experience frequent digestive symptoms (more than once a week) such as difficulty swallowing, stomach pain, bloating, vomiting blood, blood in the stool, nausea, or heartburn, which the study doctor determines may increase bleeding risk.
• People who have any significant medical condition, including but not limited to conditions affecting the lungs, heart, digestive system, blood, hormones, immune system, skin, or mental health, or any cancer or other condition the study doctor considers relevant.
• People with a history of active or previous significant bleeding (such as bleeding in the brain, stomach, or urinary tract, coughing up blood, or eye bleeding), a history of mini-stroke or stroke, unusual bleeding episodes (such as prolonged bleeding after a tooth extraction), visible bruising or small blood spots on the skin, or suspected abnormal blood vessel problems such as aneurysms.
• Men with a haemoglobin (a measure of red blood cells) below 120 g/L, or women with a haemoglobin below 110 g/L, at screening.
• People who have taken anti-inflammatory medications such as NSAIDs (including aspirin) or blood-thinning medications within 4 weeks before screening.
• People with a platelet count (cells that help blood clot) below 120 × 10⁹/L at screening.
• People whose liver enzyme blood test results (ALT, ALP, or AST) are more than 1.5 times the upper limit of normal and are considered clinically significant by the study doctor.
• People with a significantly abnormal heart tracing (ECG) — specifically a QTcF interval of 450 ms or more for men, or 470 ms or more for women — or abnormal vital signs such as blood pressure, heart rate, or breathing rate outside the specified normal ranges, at screening.
• People who have had major surgery within 3 months before the first study dose, or who are planning surgery during the study.
• People who have used prescription medications, over-the-counter medications, or dietary or herbal supplements within 14 days (or longer, depending on the product) before the first dose — except for occasional use of paracetamol (up to 2 g per day) — or who have received a long-acting injection or implant within 3 months before the first dose.
• People who have been vaccinated within 14 days before the first dose, or who plan to be vaccinated during the study.
• People who have consumed products containing quinine (such as tonic water or bitter lemon), grapefruit or grapefruit-containing products, or who have done strenuous exercise or anything else that might affect how the body processes drugs, within 7 days before the first dose.
• People with a history of drug misuse within 1 year before screening, or who have used recreational drugs such as cannabis within 1 month, or harder drugs (such as cocaine, heroin, or amphetamines) within 3 months before screening.
• People who test positive for drugs, nicotine, or alcohol at screening or at the time of admission to the study site.
• Women who test positive for pregnancy or who are breastfeeding at screening or at admission.
• People who have donated plasma within 7 days before the first dose, or who have donated or lost 500 mL or more of whole blood within 8 weeks before the first dose.
• People with a history of alcohol misuse within 1 year before screening, or who regularly drink more than 10 units of alcohol per week (for women) or 15 units per week (for men) within the 6 months before screening. (As a guide: 1 unit equals approximately 340 mL of regular beer, 140 mL of wine, or 45 mL of spirits.)
• People with known inherited conditions affecting how the body processes certain sugars, specifically galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• People who regularly consume more than 600 mg of caffeine per day within 30 days before screening, or who have consumed caffeine- or xanthine-containing foods or drinks (such as coffee, tea, chocolate, or cola) within 48 hours before the first dose.
• People who test positive for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody at screening.
• People whose kidney function test result (eGFR) is below 60 mL/min at screening, as calculated using a standard formula.
• People who have used medications known to significantly affect how the liver processes drugs (including specific liver enzyme inducers or inhibitors, such as CYP2C19 inducers or inhibitors) within 30 days before the first dose, or for 5 half-lives of that medication, whichever is longer.
• People considered ineligible for any other reason by the study doctor.

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