Effect of Food of NTQ5082 in Healthy Subjects (NCT06558656) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Effect of Food of NTQ5082 in Healthy Subjects
China12 participantsStarted 2024-08
Plain-language summary
NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, open label, two sequence, two period, double crossover-design phase 1 clinical trial to evaluate the food effect on PK after a single oral administration of NTQ5082 capsules and the safety and tolerability of single oral administration of NTQ5082 capsules on an empty stomach (i.e, fasting) as well as after a meal (i.e. fed) in healthy subjects
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Healthy male or female, ≥18 years and ≤45 years in age.
✓. 19.0 kg/m2≤BMI≤26.0 kg/m2, and male weight must be ≥50 kg, female weight must be ≥45 kg;
✓. Those who sign an informed consent form before the experiment and fully understand the content, process, and possible adverse reactions of the experiment;
✓. The subjects are able to communicate well with the researchers and understand and comply with the requirements of this study.
Exclusion criteria
✕. Participants who have participated in any other drug clinical trials and used the investigational drug within 3 months prior to the trial;
✕. Individuals who have chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, gastroesophageal reflux, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years, and who are still clinically significant according to researchers;
✕. Individuals with clear diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic disorders, etc. that require medical intervention or other diseases that are not suitable for clinical trials (such as a history of mental illness);
✕. Known or suspected history of immunodeficiency (such as frequent recurrent infections), genetic or acquired complement deficiency;
✕. There is a clear history of capsule microbial infection within the first 6 months of screening; Including but not limited to: history of infection with Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae, Legionella pneumophila;