Phase 1 Hearing Loss Trial, Not Yet 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 generally healthy males or females between 18 and 45 years old (inclusive) at the time of screening, as determined by the trial doctor based on medical history, lab results, vital signs, heart tracings, and a physical exam.
• People who are willing and able to give signed personal consent and follow all study visits, treatments, tests, lifestyle requirements, and other study procedures.
• People who weigh at least 45 kg and have a body mass index (BMI) between 19.0 and 32.0 at the time of screening.
• Male participants who have not had a sterilisation procedure and are sexually active with a female partner who could become pregnant must agree to use a condom throughout the study and for 90 days after it ends, and their female partner must also use a highly effective form of contraception; male participants must also agree not to donate sperm during this period.
• Female participants who could become pregnant and are sexually active with a non-sterilised male partner must agree to use a highly effective form of contraception (one with a failure rate no higher than 1% per year) throughout the study and for 30 days after it ends — accepted methods include an intrauterine device (IUD), bilateral tubal occlusion, a vasectomised partner (with documented confirmation of no sperm), or complete sexual abstinence if that is the participant's usual lifestyle.

Who may not be able to join:

• People who have any disease, condition, or ongoing treatment that the trial doctor believes could interfere with the study or pose an unacceptable risk.
• People who have taken part in another clinical trial or received an experimental compound within the past 30 days (or longer, depending on the drug involved).
• People who are employees of the trial site, or who are immediate family members (such as a spouse, parent, child, or sibling) of a trial site employee; also, anyone who felt pressured during the consent process.
• People who have any significant illness affecting the heart, nervous system, lungs, liver, kidneys, metabolism, digestive system, immune system, hormonal system, or mental health, or any other abnormality the trial doctor considers clinically meaningful.
• People who have a known allergy or sensitivity to any ingredient in the study drug (BF844).
• People who test positive for illegal drug use in a urine test at screening or at check-in.
• People who, in the opinion of the trial doctor, have a history of excessive alcohol or drug misuse within the past year.
• People who use or plan to use certain medications that are processed by specific liver enzymes (such as warfarin, NSAIDs, phenytoin, omeprazole, or clopidogrel), or medications that could significantly affect organ function (such as barbiturates or cimetidine), within a specified period before and during the study (confirm exact timeframes with the trial site).
• People who have taken any prescription or non-prescription medications, vitamins, or supplements within 7 days before dosing (or longer depending on the medication), unless the trial doctor determines these would not affect safety or study results.
• People who are pregnant, breastfeeding, planning to become pregnant within 30 days of the last study dose, or planning to donate eggs during that period.
• Male participants who plan to donate sperm during the study or within 90 days after the last dose.
• People who have had a gastrointestinal condition within the past 6 months that could affect how the body absorbs medications — such as malabsorption issues, bariatric surgery, bowel resection, acid reflux, peptic ulcer disease, erosive oesophagitis, or heartburn occurring more than once a week.
• People who test positive for hepatitis B, hepatitis C, or HIV at screening.
• People who have used any nicotine-containing products (such as cigarettes, cigars, pipes, chewing tobacco, nicotine patches, or nicotine gum) within 28 days before check-in, or who test positive for nicotine at screening or check-in, or who are unwilling to avoid nicotine products throughout the study.
• People who have poor vein access in their arms or hands (making blood draws difficult).
• People who have donated or lost 450 mL or more of blood, or received a blood transfusion, within the 90 days before the first dose.
• People whose heart tracing (ECG) shows a specific measurement (QTcF) at or above 450 milliseconds for males or 470 milliseconds for females at screening or check-in.
• People whose resting blood pressure is outside the range of 90–140 mmHg (top number) or 40–90 mmHg (bottom number) — a repeat measurement may be allowed (confirm with trial site).
• People whose resting heart rate is below 40 or above 100 beats per minute — a repeat measurement may be allowed (confirm with trial site).
• People whose blood test results at screening or check-in suggest a significant underlying condition, or whose liver enzyme levels (ALT and/or AST) are 1.5 times or more above the normal upper limit.
• People who are unwilling to avoid intense physical exercise in the 48 hours before any scheduled blood draws.
• People who are unwilling to avoid caffeine and caffeine-containing products (such as coffee, tea, chocolate, and caffeinated soft drinks) while staying at the clinical research unit.

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