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

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: SPH3127

• Registration Number: NCT03128138
• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-25
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-30
• Status Verified: 2021-11
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 mg SPH3127 tablet-Dose 1	SPH3127	6 Volunteers, Single dose of SPH3127 tablet, 25mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 25mg, po. 1 tablet.
50 mg SPH3127 tablet-Dose 2	SPH3127	6 Volunteers, Single dose of SPH3127 tablet, 50mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 50mg, po. 1 tablet.
100 mg SPH3127 tablet-Dose 3	SPH3127	6 Volunteers, Single dose of SPH3127 tablet, 100mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 1 tablet.
400 mg SPH3127 tablet-Dose 5	SPH3127	6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 4 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 4 tablet.
800 mg SPH3127 tablet-Dose 6	SPH3127	6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 8 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 8 tablet.
200 mg SPH3127 tablet-Dose 4	SPH3127	6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 2 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 2 tablet.

Primary Outcome Measures

Name	Time	Method
Assessment of safety parameters [adverse events, laboratory data, vital signs, and ECG]	10 days	adverse events, laboratory data, vital signs, and ECG et al.

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameter 1 [Cmax]	2 days	Peak plasma concentration (Cmax)
Assessment of PD parameter 1 [Inhibition of Renion Activity (%)]	2 days	Inhibition of Renion Activity (%)
Assessment of PD parameter 2 [Blood pressure (mmHg)]	2 days	Blood pressure (mmHg)
Assessment of PK parameter 2 [tmax]	2 days	time to peak plasma concentration (tmax)
Assessment of PK parameter 3 [AUC]	2 days	Area under the plasma concentration versus time curve (AUC)

Trial Locations

Locations (1)

The capital medical university affiliated Beijing anzhen hospital; 🇨🇳 Beijing, Beijing, China