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出境医 / 临床实验 / Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People

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

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.


Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Peripheral Drug: 25mg Drug: 50mg Drug: 100mg Drug: 200mg Drug: 400mg Drug: 800mg Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects
Actual Study Start Date : August 5, 2019
Actual Primary Completion Date : January 14, 2020
Actual Study Completion Date : January 14, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: 25mg
Tablets, Oral, 25mg, single dose
 Drug: 25mg
SYHA1402 25mg or Placebo 25mg
Experimental: 50mg
Tablets, Oral, 50mg, single dose
 Drug: 50mg
SYHA1402 50mg or Placebo 50mg
Experimental: 100mg
Tablets, Oral, 100mg, single dose
 Drug: 100mg
SYHA1402 100mg or Placebo 100mg
Experimental: 200mg
Tablets, Oral, 200mg, single dose
 Drug: 200mg
SYHA1402 200mg or Placebo 200mg
Experimental: 400mg
Tablets, Oral, 400mg, single dose
 Drug: 400mg
SYHA1402 400mg or Placebo 400mg
Experimental: 800mg
Tablets, Oral, 800mg, single dose
 Drug: 800mg
SYHA1402 800mg or Placebo 800mg
Outcome Measures
Primary Outcome Measures :
  1. Change of systolic blood pressure and diastolic blood pressure [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours ]
    To assess the change of blood pressure after administration of SYHA1402

  2. Change of heart rate [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours ]
    To assess the change of heart rate after administration of SYHA1402

  3. Change of pulse [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours ]
    To assess pulse after administration of SYHA1402

  4. Change of body temperature [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours ]
    To assess the change of body temperature after administration of SYHA1402

  5. Change of 12-lead ECG [ Time Frame: 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

  6. Change of physical examination [ Time Frame: 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

  7. Change of blood biochemistry [ Time Frame: 24, 48, 72 hours ]
    To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402

  8. Chagne of blood routine [ Time Frame: 24, 48, 72 hours ]
    To assess the change of blood routine after administration of SYHA1402

  9. Change of urinary routine [ Time Frame: 24, 48, 72 hours ]
    To assess the change of urinary routine after administration of SYHA1402


Secondary Outcome Measures :
  1. Peak concentration (Cmax) [ 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 ]
    Plasma peak concentration (Cmax) after administration of SYHA1402

  2. Peak time (Tmax) [ 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 ]
    Plasma peak time (Tmax) after administration of SYHA1402

  3. Area under the plasma concentration-time curve (AUC0-72h) [ 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 ]
    The area under the plasma concentration-time curve of SYHA1402 after administration are calculated.

  4. Half time (t1/2) [ 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 ]
    The half time of SYHA1402 after administration are calculated.

  5. Apparent clearance (CL/F) [ 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 ]
    To assess the apparent clearance (CL/F) after administration of SYHA1402

  6. 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 ]
    To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
China
The General Hospital of the People's Liberation Army
Beijing, China
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE August 5, 2019
Actual Primary Completion Date January 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Change of systolic blood pressure and diastolic blood pressure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours ]
    To assess pulse after administration of SYHA1402
  • Change of body temperature [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24, 48, 72 hours ]
    To assess the change of blood routine after administration of SYHA1402
  • Change of urinary routine [ Time Frame: 24, 48, 72 hours ]
    To assess the change of urinary routine after administration of SYHA1402
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Peak concentration (Cmax) [ 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 ]
    Plasma peak concentration (Cmax) after administration of SYHA1402
  • Peak time (Tmax) [ 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 ]
    Plasma peak time (Tmax) after administration of SYHA1402
  • Area under the plasma concentration-time curve (AUC0-72h) [ 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 ]
    The area under the plasma concentration-time curve of SYHA1402 after administration are calculated.
  • Half time (t1/2) [ 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 ]
    The half time of SYHA1402 after administration are calculated.
  • Apparent clearance (CL/F) [ 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 ]
    To assess the apparent clearance (CL/F) after administration of SYHA1402
  • 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 ]
    To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People
Official Title  ICMJE Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy Peripheral
Intervention  ICMJE
  • Drug: 25mg
    SYHA1402 25mg or Placebo 25mg
  • Drug: 50mg
    SYHA1402 50mg or Placebo 50mg
  • Drug: 100mg
    SYHA1402 100mg or Placebo 100mg
  • Drug: 200mg
    SYHA1402 200mg or Placebo 200mg
  • Drug: 400mg
    SYHA1402 400mg or Placebo 400mg
  • Drug: 800mg
    SYHA1402 800mg or Placebo 800mg
Study Arms  ICMJE
  • Experimental: 25mg
    Tablets, Oral, 25mg, single dose
    Intervention: Drug: 25mg
  • Experimental: 50mg
    Tablets, Oral, 50mg, single dose
    Intervention: Drug: 50mg
  • Experimental: 100mg
    Tablets, Oral, 100mg, single dose
    Intervention: Drug: 100mg
  • Experimental: 200mg
    Tablets, Oral, 200mg, single dose
    Intervention: Drug: 200mg
  • Experimental: 400mg
    Tablets, Oral, 400mg, single dose
    Intervention: Drug: 400mg
  • Experimental: 800mg
    Tablets, Oral, 800mg, single dose
    Intervention: Drug: 800mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2020) 		54
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2019) 		62
Actual Study Completion Date  ICMJE January 14, 2020
Actual Primary Completion Date January 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03988413
Other Study ID Numbers  ICMJE SYHA1402201801/PRO-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study Sponsor  ICMJE CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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