A Phase 1 interventional study of SPH3127 50mg and SPH3127 100mg in Hypertension, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-15.
Sponsored by Shanghai Pharmaceuticals Holding Co., Ltd · Phase 1, Interventional, and Treatment
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
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.
Exclusion Criteria:
A single dose of SPH3127 50 mg\*2 qd \*7 days
Drug: SPH3127 50mg
A single dose of placebo matching to SPH3127 50mg\*2 qd \*7 days
Drug: Placebo matching to SPH3127 50mg
A single dose of SPH3127 100 mg\*2 qd \*7 days
Drug: SPH3127 100mg
A single dose of placebo matching to SPH3127 100mg\*2 qd \*7 days
Drug: Placebo matching to SPH3127 100mg
A single dose of SPH3127 100 mg\*4 qd \*7 days
Drug: SPH3127 100mg
A single dose of placebo matching to SPH3127 100mg\*4 qd \*7 days
Drug: Placebo matching to SPH3127 100mg
SPH3127 50mg
Also known as: SPH3127 is a new study drug for hypertension
SPH3127 100mg
Also known as: SPH3127 is a new study drug for hypertension
Placebo matching to SPH3127 50mg
Also known as: Placebo is oral tablet to matching to SPH3127 50mg
Placebo matching to SPH3127 100mg
Also known as: Placebo is oral tablet to matching to SPH3127 50mg
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
Time frame: Baseline to 13-16 days post last dose
Plasma area under curve (AUC)(0-∞) of SPH3127
to evaluate Plasma AUC(0-∞) of SPH3127
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 13-16 days post last dose
Change from baseline in ECG
to evaluate the Change from baseline in ECG
Time frame: Baseline to 13-16 days post last dose
Maximum Plasma Concentration (Cmax) of SPH3127
to evaluate Plasma Cmax of SPH3127
Time frame: 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
Time frame: 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
Time frame: 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
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Pharmaceuticals Holding Co., Ltd