Skip to main content
OpenTrials
Completed

NCT Number: NCT03128138

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The capital medical university affiliated Beijing anzhen hospital

Beijing, Beijing Municipality, 100029, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPH3127

Drug

Drug: SPH3127 Tablet

Drug: Placebo Tablet

Primary outcomes

  1. Assessment of safety parameters [adverse events, laboratory data, vital signs, and ECG]

    Time frame: 10 days

    adverse events, laboratory data, vital signs, and ECG et al.

Secondary outcomes

  1. Assessment of PK parameter 1 [Cmax]

    Time frame: 2 days

    Peak plasma concentration (Cmax)

  2. Assessment of PD parameter 1 [Inhibition of Renion Activity (%)]

    Time frame: 2 days

    Inhibition of Renion Activity (%)

  3. Assessment of PD parameter 2 [Blood pressure (mmHg)]

    Time frame: 2 days

    Blood pressure (mmHg)

  4. Assessment of PK parameter 2 [tmax]

    Time frame: 2 days

    time to peak plasma concentration (tmax)

  5. Assessment of PK parameter 3 [AUC]

    Time frame: 2 days

    Area under the plasma concentration versus time curve (AUC)

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2017
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.