Back to resultsStudy on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People
Primary Purpose
Diabetic Neuropathy Peripheral
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
25mg
50mg
100mg
200mg
400mg
800mg
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy Peripheral
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.
Sites / Locations
- The General Hospital of the People's Liberation Army
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
25mg
50mg
100mg
200mg
400mg
800mg
Arm Description
Tablets, Oral, 25mg, single dose
Tablets, Oral, 50mg, single dose
Tablets, Oral, 100mg, single dose
Tablets, Oral, 200mg, single dose
Tablets, Oral, 400mg, single dose
Tablets, Oral, 800mg, single dose
Outcomes
Primary Outcome Measures
Change of systolic blood pressure and diastolic blood pressure
To assess the change of blood pressure after administration of SYHA1402
Change of heart rate
To assess the change of heart rate after administration of SYHA1402
Change of pulse
To assess pulse after administration of SYHA1402
Change of body temperature
To assess the change of body temperature after administration of SYHA1402
Change of 12-lead ECG
To assess the change of 12-lead ECG (PR，QRS，QT，QTc) after administration of SYHA1402
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
Change of blood biochemistry
To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402
Chagne of blood routine
To assess the change of blood routine after administration of SYHA1402
Change of urinary routine
To assess the change of urinary routine after administration of SYHA1402
Secondary Outcome Measures
Peak concentration (Cmax)
Plasma peak concentration (Cmax) after administration of SYHA1402
Peak time (Tmax)
Plasma peak time (Tmax) after administration of SYHA1402
Area under the plasma concentration-time curve (AUC0-72h)
The area under the plasma concentration-time curve of SYHA1402 after administration are calculated.
Half time (t1/2)
The half time of SYHA1402 after administration are calculated.
Apparent clearance (CL/F)
To assess the apparent clearance (CL/F) after administration of SYHA1402
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
Full Information
NCT ID
NCT03988413
First Posted
June 10, 2019
Last Updated
April 28, 2020
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03988413
Brief Title
Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People
Official Title
Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
January 14, 2020 (Actual)
Study Completion Date
January 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy Peripheral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
25mg
Arm Type
Experimental
Arm Description
Tablets, Oral, 25mg, single dose
Arm Title
50mg
Arm Type
Experimental
Arm Description
Tablets, Oral, 50mg, single dose
Arm Title
100mg
Arm Type
Experimental
Arm Description
Tablets, Oral, 100mg, single dose
Arm Title
200mg
Arm Type
Experimental
Arm Description
Tablets, Oral, 200mg, single dose
Arm Title
400mg
Arm Type
Experimental
Arm Description
Tablets, Oral, 400mg, single dose
Arm Title
800mg
Arm Type
Experimental
Arm Description
Tablets, Oral, 800mg, single dose
Intervention Type
Drug
Intervention Name(s)
25mg
Intervention Description
SYHA1402 25mg or Placebo 25mg
Intervention Type
Drug
Intervention Name(s)
50mg
Intervention Description
SYHA1402 50mg or Placebo 50mg
Intervention Type
Drug
Intervention Name(s)
100mg
Intervention Description
SYHA1402 100mg or Placebo 100mg
Intervention Type
Drug
Intervention Name(s)
200mg
Intervention Description
SYHA1402 200mg or Placebo 200mg
Intervention Type
Drug
Intervention Name(s)
400mg
Intervention Description
SYHA1402 400mg or Placebo 400mg
Intervention Type
Drug
Intervention Name(s)
800mg
Intervention Description
SYHA1402 800mg or Placebo 800mg
Primary Outcome Measure Information:
Title
Change of systolic blood pressure and diastolic blood pressure
Description
To assess the change of blood pressure after administration of SYHA1402
Time Frame
0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Title
Change of heart rate
Description
To assess the change of heart rate after administration of SYHA1402
Time Frame
0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Title
Change of pulse
Description
To assess pulse after administration of SYHA1402
Time Frame
0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Title
Change of body temperature
Description
To assess the change of body temperature after administration of SYHA1402
Time Frame
0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Title
Change of 12-lead ECG
Description
To assess the change of 12-lead ECG (PR，QRS，QT，QTc) after administration of SYHA1402
Time Frame
0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours
Title
Change of physical examination
Description
To assess the change of physical examination (including cardiovascular system, chest and lung, abdomen, nervous system, skeletal muscle system, etc) after administration of SYHA1402
Time Frame
24, 48, 72 hours
Title
Change of blood biochemistry
Description
To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402
Time Frame
24, 48, 72 hours
Title
Chagne of blood routine
Description
To assess the change of blood routine after administration of SYHA1402
Time Frame
24, 48, 72 hours
Title
Change of urinary routine
Description
To assess the change of urinary routine after administration of SYHA1402
Time Frame
24, 48, 72 hours
Secondary Outcome Measure Information:
Title
Peak concentration (Cmax)
Description
Plasma peak concentration (Cmax) after administration of SYHA1402
Time Frame
10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Title
Peak time (Tmax)
Description
Plasma peak time (Tmax) after administration of SYHA1402
Time Frame
10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Title
Area under the plasma concentration-time curve (AUC0-72h)
Description
The area under the plasma concentration-time curve of SYHA1402 after administration are calculated.
Time Frame
10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Title
Half time (t1/2)
Description
The half time of SYHA1402 after administration are calculated.
Time Frame
10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Title
Apparent clearance (CL/F)
Description
To assess the apparent clearance (CL/F) after administration of SYHA1402
Time Frame
10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Title
Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402
Description
To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402
Time Frame
10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
The General Hospital of the People's Liberation Army
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People
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