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Completed

NCT Number: NCT03988413

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The General Hospital of the People's Liberation Army

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

25mg

Drug

SYHA1402 25mg or Placebo 25mg

50mg

Drug

SYHA1402 50mg or Placebo 50mg

100mg

Drug

SYHA1402 100mg or Placebo 100mg

200mg

Drug

SYHA1402 200mg or Placebo 200mg

400mg

Drug

SYHA1402 400mg or Placebo 400mg

800mg

Drug

SYHA1402 800mg or Placebo 800mg

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 17, 2019
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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