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
1 other identifier
interventional
24
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hypertension
Started Oct 2017
Typical duration for phase_1 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2017
CompletedFirst Posted
Study publicly available on registry
August 21, 2017
CompletedStudy Start
First participant enrolled
October 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2018
CompletedNovember 15, 2021
November 1, 2021
11 months
August 8, 2017
November 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Plasma area under curve (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
Baseline to 13-16 days post last dose
Change from baseline in laboratory chemistry values
Baseline to 13-16 days post last dose
Change from baseline in laboratory urinalysis values
Baseline to 13-16 days post last dose
Change from baseline in ECG
Baseline to 13-16 days post last dose
- +3 more secondary outcomes
Study Arms (6)
SPH3127 100mg
EXPERIMENTALA single dose of SPH3127 50 mg\*2 qd \*7 days
Placebo to SPH3127 100mg
PLACEBO COMPARATORA single dose of placebo matching to SPH3127 50mg\*2 qd \*7 days
SPH3127 200mg
EXPERIMENTALA single dose of SPH3127 100 mg\*2 qd \*7 days
Placebo to SPH3127 200mg
PLACEBO COMPARATORA single dose of placebo matching to SPH3127 100mg\*2 qd \*7 days
SPH3127 400mg
EXPERIMENTALA single dose of SPH3127 100 mg\*4 qd \*7 days
Placebo to SPH3127 400mg
PLACEBO COMPARATORA single dose of placebo matching to SPH3127 100mg\*4 qd \*7 days
Interventions
SPH3127 50mg
SPH3127 100mg
Placebo matching to SPH3127 50mg
Placebo matching to SPH3127 100mg
Eligibility Criteria
You may qualify if:
- 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).
- Before the study,participant has know about the significance , potential benefits, inconveniences and potential risks of the study
- Participant has understood the research's procedure and sign the informed consent .
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The capital medical university affiliated Beijing anzhen hospital
Beijing, Beijing Municipality, 100029, China
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: 33653620DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2017
First Posted
August 21, 2017
Study Start
October 23, 2017
Primary Completion
September 20, 2018
Study Completion
September 20, 2018
Last Updated
November 15, 2021
Record last verified: 2021-11