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 who are in good general health based on medical history, physical examination, blood tests, and heart trace (ECG)
• People aged 18 to 64 years (inclusive)
• People with a body mass index (BMI) between 19 and 35 kg/m² at the time of screening
• People who are willing and able to understand and voluntarily sign a consent form
• Women who could become pregnant must agree to use contraception from screening until 28 days after the last dose, undergo pregnancy testing (including a negative test at screening and at admission), and agree not to donate eggs during that same period
• Men must either have had a vasectomy more than 6 months before screening, or agree to use contraception from screening until 90 days after the last dose, and agree not to donate sperm during that same period

Who may not be able to join:

• People who are staff at the study site, employees of Alcamena or their immediate family members, or those who have taken part in another clinical trial within 30 days or 5 half-lives of a previous experimental drug
• People with signs of liver disease or abnormal liver blood test results, or a positive hepatitis B or C test (people with Gilbert syndrome may still be considered)
• People with a history of kidney disease, protein in the urine, or reduced kidney function shown on screening blood tests
• People with a history of cancer that is currently active, suspected to have returned, treated within the last 6 months, or requiring ongoing therapy that affects immune, liver, or kidney function
• People with a history of heart disease, including irregular heart rhythm, heart attack, long QT syndrome, abnormal heart rhythm findings on screening ECG, or a family history of sudden unexplained death
• People currently taking medications that affect or suppress the immune system, including steroids given by any method
• People with a known autoimmune condition such as lupus, rheumatoid arthritis, sarcoidosis, or vitiligo, even if not currently being treated
• People with a positive HIV test at screening or a history of immune deficiency
• People with abnormal blood tests suggesting ongoing inflammation
• People with an active infection or currently being treated for an infection
• People with a skin condition, such as psoriasis, that could interfere with skin assessments during the study
• People with a known allergy or sensitivity to the study drug or any of its ingredients
• People with a history of alcohol or drug abuse or addiction within the past five years, a positive drug or alcohol test at screening, or who have smoked within one month before screening
• People with a serious mental health condition — such as major depression, schizophrenia, severe anxiety, eating disorders, severe attention deficit disorder, personality disorders, or suicidal thoughts or behaviour within the past five years — that could affect safety or participation
• People with low blood pressure upon standing (a significant drop in blood pressure when moving from lying down to standing) identified during screening or baseline testing
• People with abnormally low white blood cell or neutrophil counts, unless this is due to a known harmless condition such as benign ethnic neutropenia

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