herpes simplex virus infection
Conditions
Interventions
Experiment group:HN0037 Tablets
Control group:HN0037 Placebo Tablets
Sponsors
PKUCare Luzhong Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Subjects have fully understood the study, participated voluntarily and signed an informed consent form; 2) Male or female aged 18-45 years (inclusive); 3) Body mass index (BMI) between 19 and 26 kg/m2 (inclusive); 4) Good general health, with no clinically significant abnormalities; 5) Subjects (including their partners) are willing to voluntarily take at least one contraception measure from the date of signing the informed consent form until 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1) Pregnant or breastfeeding woman; 2) Previous or current significant or clinically significant disorders/abnormalities; 3) Clinically significant disorders/abnormalities that may affect subject safety or interpretation of the study results as indicated by 12-lead ECG results; 4) Positive results for hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or treponema pallidum antibody; 5) History of drug abuse, or positive results for urine drug abuse screening; 6) Any enrollment in other clinical trials within 3 months before the trial; 7) Blood loss or blood donation of more than 400 mL within 2 months before the trial; 8) Any clear history of drug or food allergy; 9) Unwillingness or inability to comply with the daily life restrictions and requirements in Section 5.3 Lifestyle Considerations of this protocol during the study; 10) Use of any other medications, including herbal remedies and dietary supplements, within 2 weeks or 5 elimination half-lives before dosing, whichever is longer (except for acetaminophen at a clinical dose and vitamins at recommended daily doses, which should be discontinued no later than 48 h before dosing); 11) History of alcohol use (consuming no less than 14 units of alcohol per week within 3 months prior to screening: 1 unit = 285 mL of beer; or 25 mL of spirits; or 100 mL of wine); 12) History of smoking (consuming an average of >= 5 cigarettes per day within 2 weeks prior to start of the study), or use of smoking cessation products or nicotine-containing products within 2 weeks prior to start of the study; 13) Positive results for alcohol breath test (alcohol breath test will only be performed on D-1); 14) Subjects considered to have other factors that are not suitable for participation in this study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Types and incidence of adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactWanmei Wang
Phaeno Therapeutics Co.,Ltd
Outcome results
None listed