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

NCT03128138 | Completed Phase 1

• 1 other identifier: SPH3127-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To explore the appropriate dose and provide the basis for the subsequent clinical trials.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

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

  10 days

Secondary Outcomes (5)

• Assessment of PK parameter 1 [Cmax]

  2 days

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

  2 days

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

  2 days

• Assessment of PK parameter 2 [tmax]

  2 days

• Assessment of PK parameter 3 [AUC]

  2 days

Study Arms (6)

25 mg SPH3127 tablet-Dose 1

EXPERIMENTAL

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

Drug: SPH3127

50 mg SPH3127 tablet-Dose 2

EXPERIMENTAL

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

Drug: SPH3127

100 mg SPH3127 tablet-Dose 3

EXPERIMENTAL

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

Drug: SPH3127

200 mg SPH3127 tablet-Dose 4

EXPERIMENTAL

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

Drug: SPH3127

400 mg SPH3127 tablet-Dose 5

EXPERIMENTAL

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

Drug: SPH3127

800 mg SPH3127 tablet-Dose 6

EXPERIMENTAL

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

Drug: SPH3127

Interventions

SPH3127 DRUG

Drug: SPH3127 Tablet Drug: Placebo Tablet

100 mg SPH3127 tablet-Dose 3; 200 mg SPH3127 tablet-Dose 4; 25 mg SPH3127 tablet-Dose 1; 400 mg SPH3127 tablet-Dose 5; 50 mg SPH3127 tablet-Dose 2; 800 mg SPH3127 tablet-Dose 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (1)

The capital medical university affiliated Beijing anzhen hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (1)

• 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.

  PMID: 33653620 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

SPH3127

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• HONG MIAO

  Shanghai Pharmaceuticals Holding Co., Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: April 25, 2017
• Study Start: December 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: July 30, 2018
• Last Updated: October 27, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)