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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SPH3127 50mg
SPH3127 100mg
Placebo matching to SPH3127 50mg
Placebo matching to SPH3127 100mg
Sponsored by
Shanghai Pharmaceuticals Holding Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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).
  2. Before the study,participant has know about the significance , potential benefits, inconveniences and potential risks of the study
  3. 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

Sites / Locations

  • The capital medical university affiliated Beijing anzhen hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

SPH3127 100mg

Placebo to SPH3127 100mg

SPH3127 200mg

Placebo to SPH3127 200mg

SPH3127 400mg

Placebo to SPH3127 400mg

Arm Description

A single dose of SPH3127 50 mg*2 qd *7 days

A single dose of placebo matching to SPH3127 50mg*2 qd *7 days

A single dose of SPH3127 100 mg*2 qd *7 days

A single dose of placebo matching to SPH3127 100mg*2 qd *7 days

A single dose of SPH3127 100 mg*4 qd *7 days

A single dose of placebo matching to SPH3127 100mg*4 qd *7 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Plasma area under curve (AUC)(0-∞) of SPH3127
to evaluate Plasma AUC(0-∞) of SPH3127
Change from baseline in laboratory hematology values
to evaluate the Change from baseline in laboratory hematology values
Change from baseline in laboratory chemistry values
to evaluate the Change from baseline in laboratory chemistry values
Change from baseline in laboratory urinalysis values
to evaluate the Change from baseline in laboratory urinalysis values
Change from baseline in ECG
to evaluate the Change from baseline in ECG
Maximum Plasma Concentration (Cmax) of SPH3127
to evaluate Plasma Cmax of SPH3127
Plasma Maximum time to peak (Tmax) of SPH3127
to evaluate Plasma Tmax of SPH3127
Apparent terminal half-life of SPH3127
to evaluate terminal half-life of SPH3127

Full Information

First Posted
August 8, 2017
Last Updated
November 11, 2021
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03255993
Brief Title
The Tolerability and Pharmacokinetics of Multiple Doses of SPH3127 in Chinese Healthy People
Official Title
Multiple Doses Study to Evaluate the Tolerability and Pharmacokinetics of SPH3127 in Chinese Healthy People
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pharmaceuticals Holding 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
Yes

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPH3127 100mg
Arm Type
Experimental
Arm Description
A single dose of SPH3127 50 mg*2 qd *7 days
Arm Title
Placebo to SPH3127 100mg
Arm Type
Placebo Comparator
Arm Description
A single dose of placebo matching to SPH3127 50mg*2 qd *7 days
Arm Title
SPH3127 200mg
Arm Type
Experimental
Arm Description
A single dose of SPH3127 100 mg*2 qd *7 days
Arm Title
Placebo to SPH3127 200mg
Arm Type
Placebo Comparator
Arm Description
A single dose of placebo matching to SPH3127 100mg*2 qd *7 days
Arm Title
SPH3127 400mg
Arm Type
Experimental
Arm Description
A single dose of SPH3127 100 mg*4 qd *7 days
Arm Title
Placebo to SPH3127 400mg
Arm Type
Placebo Comparator
Arm Description
A single dose of placebo matching to SPH3127 100mg*4 qd *7 days
Intervention Type
Drug
Intervention Name(s)
SPH3127 50mg
Other Intervention Name(s)
SPH3127 is a new study drug for hypertension
Intervention Description
SPH3127 50mg
Intervention Type
Drug
Intervention Name(s)
SPH3127 100mg
Other Intervention Name(s)
SPH3127 is a new study drug for hypertension
Intervention Description
SPH3127 100mg
Intervention Type
Drug
Intervention Name(s)
Placebo matching to SPH3127 50mg
Other Intervention Name(s)
Placebo is oral tablet to matching to SPH3127 50mg
Intervention Description
Placebo matching to SPH3127 50mg
Intervention Type
Drug
Intervention Name(s)
Placebo matching to SPH3127 100mg
Other Intervention Name(s)
Placebo is oral tablet to matching to SPH3127 50mg
Intervention Description
Placebo matching to SPH3127 100mg
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
to assess incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with increasing doses of SPH3127
Time Frame
Baseline to 13-16 days post last dose
Secondary Outcome Measure Information:
Title
Plasma area under curve (AUC)(0-∞) of SPH3127
Description
to evaluate Plasma 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
Title
Change from baseline in laboratory hematology values
Description
to evaluate the Change from baseline in laboratory hematology values
Time Frame
Baseline to 13-16 days post last dose
Title
Change from baseline in laboratory chemistry values
Description
to evaluate the Change from baseline in laboratory chemistry values
Time Frame
Baseline to 13-16 days post last dose
Title
Change from baseline in laboratory urinalysis values
Description
to evaluate the Change from baseline in laboratory urinalysis values
Time Frame
Baseline to 13-16 days post last dose
Title
Change from baseline in ECG
Description
to evaluate the Change from baseline in ECG
Time Frame
Baseline to 13-16 days post last dose
Title
Maximum Plasma Concentration (Cmax) of SPH3127
Description
to evaluate Plasma 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
Title
Plasma Maximum time to peak (Tmax) of SPH3127
Description
to evaluate Plasma 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
Title
Apparent terminal half-life of SPH3127
Description
to evaluate 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The capital medical university affiliated Beijing anzhen hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33653620
Citation
Jing S, Xu R, Yang K, Liu W, Zhang L, Ke Y, Xia G, Lin Y. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPH3127: A Phase I, Randomized, Double-Blind, Placebo-Controlled Trial. Clin Ther. 2021 Apr;43(4):735.e1-735.e14. doi: 10.1016/j.clinthera.2021.01.025. Epub 2021 Feb 27.
Results Reference
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The Tolerability and Pharmacokinetics of Multiple Doses of SPH3127 in Chinese Healthy People

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