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

NCT ID: NCT03255993

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2018-09-20

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SPH3127 100mg

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

Group Type EXPERIMENTAL

SPH3127 50mg

Intervention Type DRUG

SPH3127 50mg

Placebo to SPH3127 100mg

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

Group Type PLACEBO_COMPARATOR

Placebo matching to SPH3127 50mg

Intervention Type DRUG

Placebo matching to SPH3127 50mg

SPH3127 200mg

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

Group Type EXPERIMENTAL

SPH3127 100mg

Intervention Type DRUG

SPH3127 100mg

Placebo to SPH3127 200mg

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

Group Type PLACEBO_COMPARATOR

Placebo matching to SPH3127 100mg

Intervention Type DRUG

Placebo matching to SPH3127 100mg

SPH3127 400mg

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

Group Type EXPERIMENTAL

SPH3127 100mg

Intervention Type DRUG

SPH3127 100mg

Placebo to SPH3127 400mg

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

Group Type PLACEBO_COMPARATOR

Placebo matching to SPH3127 100mg

Intervention Type DRUG

Placebo matching to SPH3127 100mg

Interventions

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SPH3127 50mg

SPH3127 50mg

Intervention Type DRUG

SPH3127 100mg

SPH3127 100mg

Intervention Type DRUG

Placebo matching to SPH3127 50mg

Placebo matching to SPH3127 50mg

Intervention Type DRUG

Placebo matching to SPH3127 100mg

Placebo matching to SPH3127 100mg

Intervention Type DRUG

Other Intervention Names

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SPH3127 is a new study drug for hypertension SPH3127 is a new study drug for hypertension Placebo is oral tablet to matching to SPH3127 50mg Placebo is oral tablet to matching to SPH3127 50mg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Pharmaceuticals Holding Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The capital medical university affiliated Beijing anzhen hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33653620 (View on PubMed)

Other Identifiers

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SPH3127-102

Identifier Type: -

Identifier Source: org_study_id