Phase 1 Peripheral Neuropathy 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 aged 18 to 65 years.
• People with a Body Mass Index (BMI) between 19 and 32, and who weigh at least 50 kg (for men) or at least 40 kg (for women).
• People who are able to understand the study requirements, communicate with the research team, follow the planned procedures, and have given written consent to participate.
• People considered to be in good general health by the trial doctor, based on a medical check-up, physical exam, heart tracing (ECG), and blood/urine tests.
• Women who cannot become pregnant, either because they have had a hysterectomy, both fallopian tubes removed, or both ovaries removed, or because they have been through menopause (no periods for at least 12 months — a blood test may be used to confirm this).
• Men whose female partners cannot become pregnant (due to surgery or confirmed menopause), or whose female partners are already using a highly effective form of contraception (with a failure rate of less than 1% per year), or men who have had a successful vasectomy at least 3 months before the study starts.

Who may not be able to join:

• People who have a history of serious illness affecting the heart, hormones, nervous system, digestion, breathing, blood, kidneys, immune system, mental health, or metabolism, or any other condition the trial doctor believes could affect the results or safety.
• People with a history of autoimmune disease, spinal injury, or nerve-damaging conditions such as Guillain-Barré syndrome.
• People who, in the trial doctor's opinion, have a history of multiple or severe allergic reactions, including serious reactions to medications, non-prescription products, or foods.
• People who test positive at screening for HIV, Hepatitis B, or Hepatitis C.
• People who have had surgery in the 4 weeks before screening, or who plan to have surgery during the trial.
• People who have taken prescription medicines, non-prescription drugs, herbal products (including St. John's wort), or traditional medicines within 14 days (or longer, depending on the medicine) before the first dose — exceptions include paracetamol/acetaminophen, ibuprofen, and hormonal contraceptives.
• People who have taken part in another clinical trial or received an experimental drug within 30 days (or longer, depending on the drug) before the first dose.
• People who have donated more than 500 mL of blood or received a blood transfusion in the 90 days before screening, or donated plasma in the 14 days before screening.
• People who have special dietary needs or who cannot follow a standard diet during the trial.
• People who regularly drink more than 8 cups (250 mL each) of tea, coffee, or caffeinated drinks per day, within 6 months before or during the trial.
• People who test positive for alcohol at screening or on admission, who drink heavily or regularly (more than 14 units of alcohol per week in the 90 days before screening), or who are unable to avoid alcohol during the trial.
• People who have smoked more than 5 cigarettes per day, used e-cigarettes or vaping products, or are unable to avoid tobacco or nicotine products (including patches, gum, or lozenges) in the 90 days before screening and throughout the study.
• People who have used marijuana in the 90 days before screening, used harder drugs such as cocaine in the year before screening, or who test positive for drugs at screening or at the study start.
• People whose blood pressure, pulse, or breathing rate fall outside the acceptable ranges at screening or study start, unless the trial doctor considers this not to be a concern.
• People who have an abnormal heart tracing (ECG) or a specific heart rhythm measurement (QTcF) above the accepted limit (above 450 milliseconds for women, or above 430 milliseconds for men) at screening or study start.
• People with kidney or liver function that falls outside acceptable levels on blood tests at screening or study start (confirm specific thresholds with the trial site).
• People with significant problems with bleeding or blood clotting that could make blood draws or intravenous procedures difficult or unsafe.
• Women who could become pregnant and are unwilling to use a highly effective form of contraception throughout the trial and for 30 days after the last dose.
• Men who have not had a vasectomy at least 3 months before the study and who are sexually active with a female partner who could become pregnant, and who are unwilling to use both a condom and a highly effective contraceptive method (for their partner) throughout the trial and for 30 days after the last dose.
• People the trial doctor determines should not participate for any other reason.

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