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

Phase 1

Completed

• Conditions: Diabetic Neuropathy Peripheral
• Interventions: Drug: 25mg; Drug: 200mg; Drug: 50mg; Drug: 100mg; Drug: 400mg; Drug: 800mg

• Registration Number: NCT03988413
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-17
• Study Start: 2019-08-05
• Primary Completion: 2020-01-14
• Study Completion: 2020-01-14
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25mg	25mg	Tablets, Oral, 25mg, single dose
200mg	200mg	Tablets, Oral, 200mg, single dose
50mg	50mg	Tablets, Oral, 50mg, single dose
100mg	100mg	Tablets, Oral, 100mg, single dose
400mg	400mg	Tablets, Oral, 400mg, single dose
800mg	800mg	Tablets, Oral, 800mg, single dose

Primary Outcome Measures

Name	Time	Method
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
Chagne of blood routine	24, 48, 72 hours	To assess the change of blood routine after administration of SYHA1402
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 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
Change of pulse	0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours	To assess pulse 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 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 urinary routine	24, 48, 72 hours	To assess the change of urinary routine after administration of SYHA1402

Secondary Outcome Measures

Name	Time	Method
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
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
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.

Trial Locations

Locations (1)

The General Hospital of the People's Liberation Army; 🇨🇳 Beijing, China