invasive fungal infection
Conditions
Interventions
Group A:Ten volunteers were given 200 mg of the drug once a week for a total of four doses, and two volunteers were given placebo
Group B:Ten volunteers were given 400 mg of the drug once a week for a total of four doses, and two volunteers were given placebo
Group C:Ten volunteers were given 600 mg of the drug once a week for a total of four doses, and two volunteers were given placebo
Group D:Eight volunteers were given 900 mg of drug in a single dose, and two volunteers were given placebo
Group E:Eight volunteers were given 1200 mg of drug in a single dose, and two volunteers were given placebo
Sponsors
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Volunteer inclusion criteria: (1) Healthy men or women (including borderline values) aged 18~45 years; (2) Male weight = 50.0 kg, female weight = 45.0 kg, body mass index (BMI = weight (kg)/height 2 (m2)) between 19.0 and 28.0 kg/m2 (including borderline values); (3) Volunteers should not plan to give birth or donate sperm/eggs for at least 3 months from the time of signing the informed consent form to the end of the study, and should voluntarily use effective non-pharmacological contraception during the trial period, voluntary use of effective non-pharmacological contraception (including partners); (4) Before the trial, they have understood in detail the nature of the trial, its significance, possible benefits, possible inconveniences and potential dangers, and have volunteered to participate in this clinical trial, are able to communicate well with the investigator, comply with the requirements of the entire study, and have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: Volunteer exclusion criteria: (1) Known allergy to the test drug (including excipients, echinocandins), or a history of specific allergies (asthma, urticaria, eczema, etc.), or allergies (e.g., allergies to two or more medications, foods, and pollens); (2) Previous or current history of any disease that may affect the safety of the volunteers participating in the trial or the in vivo process of the investigational drug, including: a clear history of hematologic (e.g., hemolytic reaction), circulatory, gastrointestinal, urinary, respiratory, neurological, immune, endocrine, psychiatric abnormality, and metabolic disorders, or any other disease unsuitable for participation in a clinical trial; (3) Persons who have undergone major surgery within 3 months (90 days) prior to Screening; (4) who have undergone a surgical procedure that may significantly affect the pharmacokinetic profile or safety evaluation of the test drug or who plan to undergo a surgical procedure during the study period; (5) Received inactivated vaccination within 1 month prior to screening, live/attenuated vaccination within 3 months prior to screening, or plan to receive inactivated/live/attenuated vaccination during the trial; (6) Persons who have used any medication or health product (including herbal medicine) within 14 days prior to administration; (7) Persons who are known during the Screening Period to be likely to require treatment with other medications during the study; (8) who have used any clinical investigational drug within 3 months (90 days) prior to screening, or who plan to participate in another clinical trial during this study period (9) who have used any clinical investigational drug within 3 months (90 days) prior to screening or plan to participate in another clinical trial during this study (9) have donated/lost = 400 mL of blood (except for physiologic blood loss in women), received a blood transfusion, or used blood products within 3 months (90 days) prior to screening, or plan to participate in another clinical trial during the trial or during the study period; or (9) Blood donation/loss within 3 months (90 days) prior to screening, receiving a blood transfusion or using a blood product, or planning to donate blood during the trial or within 1 month of the end of the trial; (10) Those who have smoked an average of more than 5 cigarettes per day in the 3 months (90 days) prior to screening or who are unable to quit smoking during the trial; (11) Individuals who have consumed alcohol on a regular basis (more than 14 units of alcohol per week on average, 1 unit = 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine) in the 3 months (90 days) prior to screening, or who cannot stop drinking during the trial. 45 mL of 40% alcohol by volume spirits or 150 mL of wine) during the 3 months (90 days) prior to screening, or who were unable to stop drinking during the trial; (12) Excessive daily consumption of tea, coffee, or caffeinated beverages (average of more than 8 cups per day, 1 cup = 200 mL) during the 3 months (90 days) prior to screening. (12) Excessive daily consumption of tea, coffee, or caffeinated beverages (average of more than 8 cups per day, 1 cup = 200 mL) during the 3 months (90 days) prior to screening (13) Consumption of specific foods (e.g., grapefruit, grapefruit juice or grapefruit juice-containing foods/beverages, chocolate, tobacco, alcohol, caffeine-containing foods, or other foods/beverages) within 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;physical examination;vital signs;ECG;Laboratory tests; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-t;AUC0-t;AUC0-8;Tmax;Cmax;Cmax, ss;Ctrough;t1/2;R;CLz;Vz; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed