Single Ascending Dose Study of Safety and Tolerability of SPH3127 Tablet in Chinese Healthy Volunteers

Shanghai Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: SPH3127

Study type: Interventional

Funder types: Industry

Identifiers

NCT03128138

SPH3127-101

Details and patient eligibility

About

1. To evaluate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) characteristics of SPH3127 dose escalation, a single oral dose in Chines healthy volunteers.
2. To explore the appropriate dose and provide the basis for the subsequent clinical trials.

Full description

48 healthy volunteers will participate in this trial. Participants will be divided into 6 group, 25mg，50mg，100mg，200mg，400mg and 800mg. In each group, 6 participants will take SPH3127 tablet, while 2 participants will take placebo randomly. Safety data and PK/PD data will be collected as protocol described.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults,age >=18 years.Single gender should no less than a third of total subjects in each group.
• BMI should be18 to 24 kg/m2 (including threshold), allowing the lowest weight 50 kg (including threshold) for the male and 45 kg (including threshold) for the female.
• understand details of significance, benefit, inconvenience and potential danger of the research program, voluntarily signed informed consent.

Exclusion criteria

• during pregnancy, nursing mothers, and plans to test in the first 6 months (grant) pregnant;
• abnormal results in physical examination, laboratory examination and have clinical significance (such as: liver function examination - aspartate aminotransferase (AST)/alanine aminotransferase (ALT) is more than 1.5 times of the upper limit of normal).
• with cardiovascular, liver, kidney, gastrointestinal, nervous system, blood system and familial blood disease, thyroid dysfunction or abnormal mental illness;
• has a history of drug allergy and allergic constitution;
• took birth control pills within 6 weeks;
• used any drugs (including Chinese herbal medicine) within 1 week;
• participated in blood donation within 2 months ;
• participated in any drug clinical trials (as subjects) within three months;
• any positive result in virus serology check: human immunodeficiency virus antigen antibody (HIV Ag/Ab) 、hepatitis c virus (HCV) - IgG antibody to IgG, hepatitis b surface antigen (HBsAg) and treponema pallidum antibody (TP);
• addicted to cigarettes, alcohol, drink coffee, strong tea and drug abuse;
• researchers think that exists any unfavorable factors to participate in the test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 6 patient groups

25 mg SPH3127 tablet-Dose 1

Experimental group

Description:

6 Volunteers, Single dose of SPH3127 tablet, 25mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 25mg, po. 1 tablet.

Treatment:

Drug: SPH3127

50 mg SPH3127 tablet-Dose 2

Experimental group

Description:

6 Volunteers, Single dose of SPH3127 tablet, 50mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 50mg, po. 1 tablet.

Treatment:

Drug: SPH3127

100 mg SPH3127 tablet-Dose 3

Experimental group

Description:

6 Volunteers, Single dose of SPH3127 tablet, 100mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 1 tablet.

Treatment:

Drug: SPH3127

200 mg SPH3127 tablet-Dose 4

Experimental group

Description:

6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 2 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 2 tablet.

Treatment:

Drug: SPH3127

400 mg SPH3127 tablet-Dose 5

Experimental group

Description:

6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 4 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 4 tablet.

Treatment:

Drug: SPH3127

800 mg SPH3127 tablet-Dose 6

Experimental group

Description:

6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 8 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 8 tablet.

Treatment:

Drug: SPH3127