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

Shanghai Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Placebo matching to SPH3127 100mg; Drug: SPH3127 100mg; Drug: SPH3127 50mg; Drug: Placebo matching to SPH3127 50mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03255993

SPH3127-102

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 6 patient groups, including a placebo group

SPH3127 100mg

Experimental group

Description:

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

Treatment:

Drug: SPH3127 50mg

Placebo to SPH3127 100mg

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo matching to SPH3127 50mg

SPH3127 200mg

Experimental group

Description:

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

Treatment:

Drug: SPH3127 100mg

Placebo to SPH3127 200mg

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo matching to SPH3127 100mg

SPH3127 400mg

Experimental group

Description:

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

Treatment:

Drug: SPH3127 100mg

Placebo to SPH3127 400mg

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo matching to SPH3127 100mg