Diabetic Neuropathy Peripheral
Conditions
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.
Interventions
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18≤Age≤45, male or female; 2. Body weight (\> 45.0 kg (female) or 50.0 kg (male), 19.0 kg/m2 (\< BMI) = 26.0 kg/m2); 3. Subjects with normal clinical significance by medical history, vital signs, physical examination and laboratory examination; 4. 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; 5. Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal.
Exclusion criteria
1. Female subjects: pregnant or lactating, or planned pregnancy; male subjects: their partner planned pregnancy, or planned to donate sperm; 2. Have neurological or psychiatric diseases history, or have serious cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive, immune and other systemic diseases history; 3. Surgery history within six months before signing the informed consent; 4. Allergic history to more than one drug or other serious allergic rhistory. 5. Subjects with a QTc interval greater than 450 ms (male) or 470 MS (female), or with a history of prolonged QTc interval; 6. Positive with serum immunological test for HBsAg, Anti-HCV, Anti-HIV or Anti-TP; 7. History of drugs or drug abuse or alcoholics; 8. History of blood donation more than 200 mL within 8 weeks before signing informed consent; 9. Subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent; 10. Not suitable for this trial according to the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of systolic blood pressure and diastolic blood pressure | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours | To assess the change of blood pressure after administration of SYHA1402 |
| Change of heart rate | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours | To assess the change of heart rate after administration of SYHA1402 |
| Change of pulse | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours | To assess pulse after administration of SYHA1402 |
| Change of body temperature | 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours | To assess the change of body temperature after administration of SYHA1402 |
| Change of 12-lead ECG | 0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours | To assess the change of 12-lead ECG (PR，QRS，QT，QTc) after administration of SYHA1402 |
| Change of physical examination | 24, 48, 72 hours | To assess the change of physical examination (including cardiovascular system, chest and lung, abdomen, nervous system, skeletal muscle system, etc) after administration of SYHA1402 |
| Change of blood biochemistry | 24, 48, 72 hours | To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402 |
| Chagne of blood routine | 24, 48, 72 hours | To assess the change of blood routine after administration of SYHA1402 |
| Change of urinary routine | 24, 48, 72 hours | To assess the change of urinary routine after administration of SYHA1402 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak concentration (Cmax) | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours | Plasma peak concentration (Cmax) after administration of SYHA1402 |
| Peak time (Tmax) | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours | Plasma peak time (Tmax) after administration of SYHA1402 |
| Area under the plasma concentration-time curve (AUC0-72h) | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours | The area under the plasma concentration-time curve of SYHA1402 after administration are calculated. |
| Half time (t1/2) | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours | The half time of SYHA1402 after administration are calculated. |
| Apparent clearance (CL/F) | 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours | To assess the apparent clearance (CL/F) after administration of SYHA1402 |
| 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 | To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402 |
Countries
China
Outcome results
None listed