Phase 1 Vasculitis 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 willing and able to sign a consent form before any study activities begin
• People aged 23 to 59 years old (inclusive)
• People who weigh at least 50 kg at the time of the screening appointment
• People with a body mass index (BMI) between 18.5 and 29.9 at the time of screening (confirm with trial site if unsure how to calculate BMI)
• People who are in generally good health with no significant medical conditions, as determined by the trial doctor
• People who currently smoke at least 10 cigarettes per day and have done so for at least 2 years, without stopping for more than 6 months at any point
• Female participants who agree not to donate eggs during the study and for 90 days after receiving the study treatment
• Female participants who are able to become pregnant must use an approved and effective form of birth control starting 30 days before screening through to 90 days after receiving the study treatment
• Female participants who cannot become pregnant must either have had a surgical procedure that prevents pregnancy (such as removal of the uterus, fallopian tubes, or ovaries, or tubal ligation), or have been through menopause for at least one year
• Male participants who agree to use contraception and not donate sperm for 90 days after receiving the study treatment
• People willing to avoid all tobacco products other than cigarettes from 2 days before the study through to Day 84
• People willing to avoid all nicotine products other than cigarettes from 2 days before the study through to Day 84
• People willing to stop smoking regular cigarettes for approximately 18 hours before the first dose and approximately 42 hours before the second dose (confirm exact timing with trial site)

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant
• Female participants with a positive pregnancy test at screening or on Day -2
• People who have previously received any vaccine or antibody treatment designed to target nicotine
• People who have used menthol tobacco products within 30 days before screening, or who are unwilling to avoid them during the study
• People who have had a severe allergic reaction to an antibody or vaccine in the past, including a condition called Guillain-Barré syndrome
• People who have received any vaccine within 90 days before screening
• People with a history of significant allergic reactions (mild seasonal allergies are generally permitted — confirm with trial site)
• People who have used steroid tablets or capsules, or drugs that affect the immune system, within the past 90 days (inhaled steroids are generally permitted — confirm with trial site)
• People with a history of cancer (except certain treated skin cancers), HIV, other immune system disorders, or autoimmune disease
• People with a history of drug or alcohol use disorder (excluding nicotine dependence), as defined by standard diagnostic criteria
• People with a significant heart, lung, liver, kidney, digestive, hormonal, nerve, or mental health condition, as determined by the trial doctor
• People with significantly abnormal blood or urine test results at screening or on Day -2, as determined by the trial doctor
• People who have had COVID-19 in the past 6 months, or who still have ongoing symptoms thought to be related to a past COVID-19 infection
• People who have used stop-smoking medicines — such as varenicline, bupropion, nicotine replacement therapy, nortriptyline, clonidine, or cytisinicline — within 90 days before screening
• People who have taken part in another clinical trial within 30 days before screening (or 90 days for biological treatments, or 5 times the drug's half-life — whichever is longest)
• People whose exhaled carbon monoxide reading is below 8 ppm at screening (this is a breath test used to confirm smoking status — confirm with trial site)
• People who test positive for hepatitis B, hepatitis C, or HIV at screening
• People who test positive for alcohol in a urine test at screening or on Day -2
• People who test positive for drugs such as cocaine, amphetamines, barbiturates, opiates, benzodiazepines, or cannabis in a urine test at screening or on Day -2
• People unwilling to avoid caffeine-containing foods and drinks (such as coffee, tea, cola, chocolate, and energy drinks) from 24 hours before entering the study facility until discharge
• People unwilling to avoid alcohol from 24 hours before entering the study facility until discharge
• People who have donated blood or lost more than 500 mL of blood within 56 days before screening
• People who have donated plasma or had significant plasma loss within 30 days before screening through to Day 84
• People who have a known sensitivity or allergic reaction to the study drug or its ingredients
• People who are unwilling or unable to follow the study requirements and instructions
• People who are currently taking part in another clinical study

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