The Tolerability and Pharmacokinetics of Multiple Doses of SPH3127 in Chinese Healthy People

Multiple Doses Study to Evaluate the Tolerability and Pharmacokinetics of SPH3127 in Chinese Healthy People

This study was a single center, parallel, randomized, double blind, placebo-controlled phase Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127 tablet in healthy subjects by increasing multiple dosing

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: SPH3127 50mg; Drug: Placebo matching to SPH3127 50mg; Drug: SPH3127 100mg; Drug: Placebo matching to SPH3127 100mg

Detailed Description

Three panels(100mg, 200mg, 400mg), each consisting of eight participants (The number of individual subjects in each group was not less than 1/3 of the total number).Participants begin to receive the first dose of SPH3127 100mg. Then Participants begin to receive the second dose of SPH3127 200mg,after the researchers confirmed that the 100mg dose group was safe and well tolerated.Then the third dose of SPH3127 400mg must wait for the result of the second dose's safety and tolerability. If the subjects during escalating dose to the biggest tolerate dose group were not well tolerated, the study must adjust the maximum dose group and fall to a low dose group to conduct another test.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • The capital medical university affiliated Beijing anzhen hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The body mass index is 18-28kg/m2 (including the critical value), which allows the minimum weight of men to be 50kg (including the critical value) and 45kg for women (including the critical value).
2. Before the study,participant has know about the significance , potential benefits, inconveniences and potential risks of the study
3. Participant has understood the research's procedure and sign the informed consent .

Exclusion Criteria:

• Participant who are Pregnancy, lactating women, and planned trials begin within six months of pregnancy
• Participant who has abnormal Physical examination, laboratory examination results and clinical significance (such as: liver function examination - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times that of the upper limit of normal)
• Participant who has a history of cardiovascular, liver, kidney, digestive tract, nervous system, blood system, familial hematologic disease, abnormal thyroid function, or mental abnormality
• Participant who has drug allergy history and anaphylactic reaction
• Participant who took oral contraceptive in 6 months
• Participant who used any drug (including Chinese herbal medicine) within 1 week.
• Participant who donated blood within 2 months
• Participant who participated clinical trials of any drug in 3 months (as subjects)
• Participant who has any positive result of virus serology check: human immunodeficiency virus antigen antibody (HIV Ag/Ab) and hepatitis c virus (HCV) - immunoglobulin G(IgG) antibody to IgG, hepatitis b surface antigen (HBsAg) and treponema pallidum antibody (TP)
• Participant who are used to smoke, alcohol abuse, eat coffee and strong tea and drug abuse
• Participant who the researchers believe that there are volunteers who are not suitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPH3127 100mg; A single dose of SPH3127 50 mg*2 qd *7 days	Drug: SPH3127 50mg; SPH3127 50mg; Other Names: SPH3127 is a new study drug for hypertension
Placebo Comparator: Placebo to SPH3127 100mg; A single dose of placebo matching to SPH3127 50mg*2 qd *7 days	Drug: Placebo matching to SPH3127 50mg; Placebo matching to SPH3127 50mg; Other Names: Placebo is oral tablet to matching to SPH3127 50mg
Experimental: SPH3127 200mg; A single dose of SPH3127 100 mg*2 qd *7 days	Drug: SPH3127 100mg; SPH3127 100mg; Other Names: SPH3127 is a new study drug for hypertension
Placebo Comparator: Placebo to SPH3127 200mg; A single dose of placebo matching to SPH3127 100mg*2 qd *7 days	Drug: Placebo matching to SPH3127 100mg; Placebo matching to SPH3127 100mg; Other Names: Placebo is oral tablet to matching to SPH3127 50mg
Experimental: SPH3127 400mg; A single dose of SPH3127 100 mg*4 qd *7 days	Drug: SPH3127 100mg; SPH3127 100mg; Other Names: SPH3127 is a new study drug for hypertension
Placebo Comparator: Placebo to SPH3127 400mg; A single dose of placebo matching to SPH3127 100mg*4 qd *7 days	Drug: Placebo matching to SPH3127 100mg; Placebo matching to SPH3127 100mg; Other Names: Placebo is oral tablet to matching to SPH3127 50mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	to assess incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with increasing doses of SPH3127	Baseline to 13-16 days post last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma area under curve (AUC)(0-∞) of SPH3127	to evaluate Plasma AUC(0-∞) of SPH3127	10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7; 10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
Change from baseline in laboratory hematology values	to evaluate the Change from baseline in laboratory hematology values	Baseline to 13-16 days post last dose
Change from baseline in laboratory chemistry values	to evaluate the Change from baseline in laboratory chemistry values	Baseline to 13-16 days post last dose
Change from baseline in laboratory urinalysis values	to evaluate the Change from baseline in laboratory urinalysis values	Baseline to 13-16 days post last dose
Change from baseline in ECG	to evaluate the Change from baseline in ECG	Baseline to 13-16 days post last dose
Maximum Plasma Concentration (Cmax) of SPH3127	to evaluate Plasma Cmax of SPH3127	10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
Plasma Maximum time to peak (Tmax) of SPH3127	to evaluate Plasma Tmax of SPH3127	10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
Apparent terminal half-life of SPH3127	to evaluate terminal half-life of SPH3127	10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): September 20, 2018

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: SPH3127-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No