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Completed

NCT Number: NCT03255993

The Tolerability and Pharmacokinetics of Multiple Doses of SPH3127 in Chinese Healthy People

This study was a single center, parallel, randomized, double blind, placebo-controlled phase Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127 tablet in healthy subjects by increasing multiple dosing

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The capital medical university affiliated Beijing anzhen hospital

Beijing, Beijing Municipality, 100029, China

About this study

Three panels(100mg, 200mg, 400mg), each consisting of eight participants (The number of individual subjects in each group was not less than 1/3 of the total number).Participants begin to receive the first dose of SPH3127 100mg. Then Participants begin to receive the second dose of SPH3127 200mg,after the researchers confirmed that the 100mg dose group was safe and well tolerated.Then the third dose of SPH3127 400mg must wait for the result of the second dose's safety and tolerability. If the subjects during escalating dose to the biggest tolerate dose group were not well tolerated, the study must adjust the maximum dose group and fall to a low dose group to conduct another test.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The body mass index is 18-28kg/m2 (including the critical value), which allows the minimum weight of men to be 50kg (including the critical value) and 45kg for women (including the critical value).
  • Before the study,participant has know about the significance , potential benefits, inconveniences and potential risks of the study
  • Participant has understood the research's procedure and sign the informed consent .

Exclusion criteria

  • Participant who are Pregnancy, lactating women, and planned trials begin within six months of pregnancy
  • Participant who has abnormal Physical examination, laboratory examination results and clinical significance (such as: liver function examination - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times that of the upper limit of normal)
  • Participant who has a history of cardiovascular, liver, kidney, digestive tract, nervous system, blood system, familial hematologic disease, abnormal thyroid function, or mental abnormality
  • Participant who has drug allergy history and anaphylactic reaction
  • Participant who took oral contraceptive in 6 months
  • Participant who used any drug (including Chinese herbal medicine) within 1 week.
  • Participant who donated blood within 2 months
  • Participant who participated clinical trials of any drug in 3 months (as subjects)
  • Participant who has any positive result of virus serology check: human immunodeficiency virus antigen antibody (HIV Ag/Ab) and hepatitis c virus (HCV) - immunoglobulin G(IgG) antibody to IgG, hepatitis b surface antigen (HBsAg) and treponema pallidum antibody (TP)
  • Participant who are used to smoke, alcohol abuse, eat coffee and strong tea and drug abuse
  • Participant who the researchers believe that there are volunteers who are not suitable for the study

Treatment and study plan

SPH3127 50mg

Drug

SPH3127 50mg

Other names: SPH3127 is a new study drug for hypertension

SPH3127 100mg

Drug

SPH3127 100mg

Other names: SPH3127 is a new study drug for hypertension

Placebo matching to SPH3127 50mg

Drug

Placebo matching to SPH3127 50mg

Other names: Placebo is oral tablet to matching to SPH3127 50mg

Placebo matching to SPH3127 100mg

Drug

Placebo matching to SPH3127 100mg

Other names: Placebo is oral tablet to matching to SPH3127 50mg

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Baseline to 13-16 days post last dose

    to assess incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with increasing doses of SPH3127

Secondary outcomes

  1. Plasma area under curve (AUC)(0-∞) of SPH3127

    Time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7; 10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6

    to evaluate Plasma AUC(0-∞) of SPH3127

  2. Change from baseline in laboratory hematology values

    Time frame: Baseline to 13-16 days post last dose

    to evaluate the Change from baseline in laboratory hematology values

  3. Change from baseline in laboratory chemistry values

    Time frame: Baseline to 13-16 days post last dose

    to evaluate the Change from baseline in laboratory chemistry values

  4. Change from baseline in laboratory urinalysis values

    Time frame: Baseline to 13-16 days post last dose

    to evaluate the Change from baseline in laboratory urinalysis values

  5. Change from baseline in ECG

    Time frame: Baseline to 13-16 days post last dose

    to evaluate the Change from baseline in ECG

  6. Maximum Plasma Concentration (Cmax) of SPH3127

    Time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6

    to evaluate Plasma Cmax of SPH3127

  7. Plasma Maximum time to peak (Tmax) of SPH3127

    Time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6

    to evaluate Plasma Tmax of SPH3127

  8. Apparent terminal half-life of SPH3127

    Time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6

    to evaluate terminal half-life of SPH3127

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study title

Multiple Doses Study to Evaluate the Tolerability and Pharmacokinetics of SPH3127 in Chinese Healthy People

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2017
Registry last updated
Nov 15, 2021

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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