GW117 ODT （Orally Disintegrating Tablets） Safety and Pharmacokinetics Study in Healthy Subjects

Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in Chinese healthy volunteers.

Inclusion criteria

• Body weight should be at least 50.0kg for males and 45.0kg for females, with body mass index (weight/height 2) in the range of 19-26 kg/m2
• The results of physical examination were normal or abnormal without clinical significance;
• The results of vital signs were normal or abnormal without clinical significance
• The results of laboratory tests (blood routine, urine routine, liver function, renal function, blood glucose, electrolytes, coagulation function) were normal or abnormal without clinical significance
• negative results of pregnancy examination
• normal serological test results (five hepatitis B tests, hepatitis C antibodies, syphilis sero-specific antibodies, HIV antibodies)
• Normal or approximately normal or abnormal results of 12-lead electrocardiogram were not clinically significant
• Normal or abnormal chest X-ray findings had no clinical significance
• The normal or abnormal results of abdominal ultrasound had no clinical significance;
• Alcohol breath test results were negative
• Urine nicotine test results were negative
• Urine drug screening (morphine, methamphetamines, ketamine, dimethylenedioxyamphetamine, and tetrahydrocannabinol acid) was negative

Exclusion criteria

• Allergic constitution or a history of drug or food allergy
• any medical history that may affect the safety of the trial or the in vivo course of the drug
• any history of surgery or trauma that may affect the safety of the trial or the course of the drug in vivo
• currently suffering from any unstable or recurrent disease or disease affecting the course of the drug in vivo
• a history of drug abuse/dependence in the past 2 years
• any medications used within 14 days before the test
• smoking within 2 weeks before medication or during the study period;
• alcohol abuse [drinking more than 14 units of alcohol per week in the 3 months before screening (1 unit of alcohol ≈360mL of 5% beer or 45mL of 40% spirits or 150mL of 12% wine)], or drinking alcohol within 1 week before medication, or unable to abstain from alcohol during the study
• participated in other drug clinical trials within 90 days before the trial
• blood loss or donation of 400mL or more within 90 days before the test;
• a history of fainting or bleeding
• lactating women
• plan to donate sperm or egg, plan to have children, or be unwilling or unable to take effective contraceptive measures within 30 days before the trial to 6 months after the end of the trial
• abnormal neurological or mental status or language disorder
• patients with abnormal saliva secretion, severe oral ulcer or other oral mucosal diseases;
• The investigators considered that they were not suitable to participate in the trial due to other circumstances