Safety, Tolerability, and Pharmacokinetics of FHND1002 Granules in Healthy Adults

Korábbi kezelés

• History of severe allergies (e.g., angioedema or anaphylactic shock), hypersensitivity (e.g., to pollen or two or more drugs/foods), or known allergy to any components or excipients of the investigational drug.
• Use of any drugs that inhibit or induce hepatic drug metabolism (e.g., barbiturates, carbamazepine, phenytoin, corticosteroids) within 28 days before screening.
• Underwent surgery within six months prior to screening or had surgery affecting drug absorption, distribution, metabolism, or excretion, as determined to be clinically significant by the investigator; or plans to undergo surgery during the study period.
• Use of any prescription drugs, over-the-counter drugs, herbal medicines, or vitamins within 14 days prior to screening or within five half-lives of the drug before the first dose of the study drug (unless deemed irrelevant by the investigator).
• Participation in another clinical trial with drug administration within three months prior to the first dose of the study drug.
• Blood donation or other causes of blood loss exceeding 400 mL within three months prior to screening (excluding physiological blood loss in females).
• Frequent alcohol consumption within three months prior to screening (defined as more than 14 units of alcohol per week, where 1 unit = 360 mL of beer, 45 mL of spirits with 40% alcohol, or 150 mL of wine), a positive alcohol breath test result, or inability to abstain from alcohol during the study.
• Vaccination within one month prior to the first dose or planned vaccination during the study or within one month after the study.
• Smoking more than five cigarettes per day within three months prior to screening or inability to abstain from tobacco use during the study.
• Excessive consumption of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, where 1 cup = 250 mL) within three months prior to screening, consumption of specific foods (e.g., dragon fruit, mango, grapefruit) within 14 days prior to screening, or unwillingness to avoid caffeine-containing foods and beverages (e.g., tea, coffee, chocolate, cocoa), grapefruit products, or strenuous activities that may affect drug absorption, metabolism, or excretion during the study.
• Male volunteers (or their partners) or female volunteers with plans for conception during the study period or within three months after study completion, or unwillingness to use non-drug contraceptive measures (e.g., complete abstinence, condoms, sterilization) during the study.

Más betegség

• History or presence of gastrointestinal, renal, hepatic, pulmonary, neurological, hematological, endocrine, oncological, immunological, psychiatric, or cardiovascular diseases that, in the investigator's opinion, may affect the safety of the volunteer or study results.
• Difficulty swallowing or a history of gastrointestinal diseases affecting drug absorption, digestive system surgeries (except for appendectomy, hemorrhoidectomy, or inguinal hernia repair), or known factors affecting pharmacokinetics.
• History of drug abuse, drug dependence, or a positive drug abuse screening result.
• Difficulty with venous blood collection or a history of needle or blood phobia.
• Positive serological results for HBsAg, anti-HCV, anti-HIV, or TP-Ab at screening.
• Any other condition or factor that, in the investigator's judgment, renders the volunteer unsuitable for participation in the clinical trial.

Laborértékek

• Abnormal results in vital signs, electrocardiograms, ultrasounds, chest X-rays, or laboratory tests (e.g., blood routine, urinalysis, coagulation, blood biochemistry) deemed clinically significant by the investigator.
• Pregnant or breastfeeding female volunteers, or positive serum pregnancy test results.

Egyéb

• Volunteers with specific dietary requirements (e.g., lactose intolerance) or unwillingness to adhere to the standardized diet provided during the study.

• Aged ≥18 and ≤45 years, regardless of gender.
• Male volunteers weigh ≥50 kg, and female volunteers weigh ≥45 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive).
• Medical history, physical examination, laboratory tests, and other assessments are normal or clinically insignificant, as determined by the investigator.
• Volunteers have no plans for pregnancy and voluntarily agree to use effective non-drug contraceptive measures (e.g., complete abstinence, condoms, sterilization) throughout the study and for three months after the last dose, with no plans for sperm or egg donation.
• Volunteers agree to comply with all study procedures and follow-up schedules and provide written informed consent.