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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Drug: SPH3127 Tablet Drug: Placebo Tablet
The capital medical university affiliated Beijing anzhen hospital
Beijing, Beijing Municipality, China
Assessment of safety parameters [adverse events, laboratory data, vital signs, and ECG]
adverse events, laboratory data, vital signs, and ECG et al.
Time frame: 10 days
Assessment of PK parameter 1 [Cmax]
Peak plasma concentration (Cmax)
Time frame: 2 days
Assessment of PD parameter 1 [Inhibition of Renion Activity (%)]
Inhibition of Renion Activity (%)
Time frame: 2 days
Assessment of PD parameter 2 [Blood pressure (mmHg)]
Blood pressure (mmHg)
Time frame: 2 days
Assessment of PK parameter 2 [tmax]
time to peak plasma concentration (tmax)
Time frame: 2 days
Assessment of PK parameter 3 [AUC]
Area under the plasma concentration versus time curve (AUC)
Time frame: 2 days
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