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

Diabetic Neuropathy Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988413
• Other study ID #: SYHA1402201801/PRO-1
• Status: Completed
• Phase: Phase 1
• Start date: August 5, 2019
• Est. completion date: January 14, 2020

Study information

• Verified date: June 2019
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 14, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy Peripheral
• Peripheral Nervous System Diseases

Intervention

Drug:
• 25mg
SYHA1402 25mg or Placebo 25mg
• 50mg
SYHA1402 50mg or Placebo 50mg
• 100mg
SYHA1402 100mg or Placebo 100mg
• 200mg
SYHA1402 200mg or Placebo 200mg
• 400mg
SYHA1402 400mg or Placebo 400mg
• 800mg
SYHA1402 800mg or Placebo 800mg

Locations

Country	Name	City	State
China	The General Hospital of the People's Liberation Army	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change of pulse	To assess pulse after administration of SYHA1402	0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Chagne of blood routine	To assess the change of blood routine after administration of SYHA1402	24, 48, 72 hours
Primary	Change of urinary routine	To assess the change of urinary routine after administration of SYHA1402	24, 48, 72 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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