Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People

Study Overview
=================
Brief Summary
-----------------
The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study. The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.

Official Title
-----------------
Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects

Conditions
-----------------
Diabetic Neuropathy Peripheral

Intervention / Treatment
-----------------
* Drug: 25mg
* Drug: 50mg
* Drug: 100mg
* Drug: 200mg
* Drug: 400mg
* Drug: 800mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18≤Age≤45, male or female; Body weight (> 45.0 kg (female) or 50.0 kg (male), 19.0 kg/m2 (< BMI) = 26.0 kg/m2); Subjects with normal clinical significance by medical history, vital signs, physical examination and laboratory examination; All subjects who adopt effective non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs, etc.) from the signing of informed consent to three months after the end of the study; Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal. Exclusion Criteria: Female subjects: pregnant or lactating, or planned pregnancy; male subjects: their partner planned pregnancy, or planned to donate sperm; Have neurological or psychiatric diseases history, or have serious cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive, immune and other systemic diseases history; Surgery history within six months before signing the informed consent; Allergic history to more than one drug or other serious allergic rhistory. Subjects with a QTc interval greater than 450 ms (male) or 470 MS (female), or with a history of prolonged QTc interval; Positive with serum immunological test for HBsAg, Anti-HCV, Anti-HIV or Anti-TP; History of drugs or drug abuse or alcoholics; History of blood donation more than 200 mL within 8 weeks before signing informed consent; Subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent; Not suitable for this trial according to the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25mg<br>Tablets, Oral, 25mg, single dose | Drug: 25mg<br>* SYHA1402 25mg or Placebo 25mg<br>|
| Experimental: 50mg<br>Tablets, Oral, 50mg, single dose | Drug: 50mg<br>* SYHA1402 50mg or Placebo 50mg<br>|
| Experimental: 100mg<br>Tablets, Oral, 100mg, single dose | Drug: 100mg<br>* SYHA1402 100mg or Placebo 100mg<br>|
| Experimental: 200mg<br>Tablets, Oral, 200mg, single dose | Drug: 200mg<br>* SYHA1402 200mg or Placebo 200mg<br>|
| Experimental: 400mg<br>Tablets, Oral, 400mg, single dose | Drug: 400mg<br>* SYHA1402 400mg or Placebo 400mg<br>|
| Experimental: 800mg<br>Tablets, Oral, 800mg, single dose | Drug: 800mg<br>* SYHA1402 800mg or Placebo 800mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of systolic blood pressure and diastolic blood pressure | To assess the change of blood pressure after administration of SYHA1402 | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours | 
| Change of heart rate | To assess the change of heart rate after administration of SYHA1402 | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours | 
| Change of pulse | To assess pulse after administration of SYHA1402 | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours | 
| Change of body temperature | To assess the change of body temperature after administration of SYHA1402 | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours | 
| Change of 12-lead ECG | To assess the change of 12-lead ECG (PR，QRS，QT，QTc) after administration of SYHA1402 | 0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours | 
| Change of physical examination | To assess the change of physical examination (including cardiovascular system, chest and lung, abdomen, nervous system, skeletal muscle system, etc) after administration of SYHA1402 | 24, 48, 72 hours | 
| Change of blood biochemistry | To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402 | 24, 48, 72 hours | 
| Chagne of blood routine | To assess the change of blood routine after administration of SYHA1402 | 24, 48, 72 hours | 
| Change of urinary routine | To assess the change of urinary routine after administration of SYHA1402 | 24, 48, 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak concentration (Cmax) | Plasma peak concentration (Cmax) after administration of SYHA1402 | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours | 
| Peak time (Tmax) | Plasma peak time (Tmax) after administration of SYHA1402 | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours | 
| Area under the plasma concentration-time curve (AUC0-72h) | The area under the plasma concentration-time curve of SYHA1402 after administration are calculated. | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours | 
| Half time (t1/2) | The half time of SYHA1402 after administration are calculated. | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours | 
| Apparent clearance (CL/F) | To assess the apparent clearance (CL/F) after administration of SYHA1402 | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours | 
| Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402 | To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402 | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours |