Clinical trial NCT03128138: Single Ascending Dose Study of Safety and Tolerability of SPH3127 Tablet in Chinese Healthy Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Describe Pharmacokinetics/Pharmacodynamics, and the Safety and of SPH3127 Tablet in Chinese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of safety parameters [adverse events, laboratory data, vital signs, and ECG]
timeFrame: 10 days
Secondary outcomes:
measure: Assessment of PK parameter 1 [Cmax]
timeFrame: 2 days
measure: Assessment of PD parameter 1 [Inhibition of Renion Activity (%)]
timeFrame: 2 days
measure: Assessment of PD parameter 2 [Blood pressure (mmHg)]
timeFrame: 2 days
measure: Assessment of PK parameter 2 [tmax]
timeFrame: 2 days
measure: Assessment of PK parameter 3 [AUC]
timeFrame: 2 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: The capital medical university affiliated Beijing anzhen hospital
state: Beijing
Study officials:
affiliation: Shanghai Pharmaceuticals Holding Co., Ltd
name: HONG MIAO
role: PRINCIPAL_INVESTIGATOR
References:
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.