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CompletedNCT03988413Updated Apr 30, 2020

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

A Phase 1 interventional study of 25mg and 50mg in Diabetic Neuropathy Peripheral, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-30.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Neuropathy Peripheral
03

In context

Diabetic Neuropathies

617 studies on the registry are indexed under Diabetic Neuropathies; 91 are open to participants now.

This study's enrollment of 54 is below the median of 73 across 510 interventional studies indexed under Diabetic Neuropathies.

Browse Diabetic Neuropathies studies →

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 161 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    25mg

    Tablets, Oral, 25mg, single dose

    Drug: 25mg

  • Experimental
    50mg

    Tablets, Oral, 50mg, single dose

    Drug: 50mg

  • Experimental
    100mg

    Tablets, Oral, 100mg, single dose

    Drug: 100mg

  • Experimental
    200mg

    Tablets, Oral, 200mg, single dose

    Drug: 200mg

  • Experimental
    400mg

    Tablets, Oral, 400mg, single dose

    Drug: 400mg

  • Experimental
    800mg

    Tablets, Oral, 800mg, single dose

    Drug: 800mg

Interventions

  • Drug25mg

    SYHA1402 25mg or Placebo 25mg

  • Drug50mg

    SYHA1402 50mg or Placebo 50mg

  • Drug100mg

    SYHA1402 100mg or Placebo 100mg

  • Drug200mg

    SYHA1402 200mg or Placebo 200mg

  • Drug400mg

    SYHA1402 400mg or Placebo 400mg

  • Drug800mg

    SYHA1402 800mg or Placebo 800mg

06

What researchers measure

Primary outcomes

  1. Change of systolic blood pressure and diastolic blood pressure

    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

  2. Change of heart rate

    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

  3. Change of pulse

    To assess pulse after administration of SYHA1402

    Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours

  4. Change of body temperature

    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

  5. Change of 12-lead ECG

    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

  6. 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

    Time frame: 24, 48, 72 hours

  7. Change of blood biochemistry

    To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402

    Time frame: 24, 48, 72 hours

  8. Chagne of blood routine

    To assess the change of blood routine after administration of SYHA1402

    Time frame: 24, 48, 72 hours

  9. Change of urinary routine

    To assess the change of urinary routine after administration of SYHA1402

    Time frame: 24, 48, 72 hours

Secondary outcomes

  1. Peak concentration (Cmax)

    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

  2. Peak time (Tmax)

    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

  3. Area under the plasma concentration-time curve (AUC0-72h)

    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

  4. Half time (t1/2)

    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

  5. Apparent clearance (CL/F)

    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

  6. 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

    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

07

Study locations

1 site
  • The General Hospital of the People's Liberation Army
    Beijing, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03988413
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Jun 17, 2019
Start date
Aug 5, 2019
Primary completion
Jan 14, 2020
Completion
Jan 14, 2020
Last update
Apr 30, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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