This is a randomized, double-blind, placebo-controlled, single-dose with three incremental doses, Phase 1 study to evaluate the tolerance and pharmacokinetics of suramin sodium for injection in Chinese healthy adults.
A total of 36 subjects are divided into three dosage groups: 10mg/kg, 15mg/kg and 20mg/kg, in which 20mg/kg is the conventional dosage per international pharmacopoeias for established indications of suramin sodium. Each dose group contains 12 subjects. By randomization, 10 of them receive suramin sodium while 2 of them receive placebo (0.9% sodium chloride injection). The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated. All subjects in each dose group will be un-blinded after blood/urine collection and safety evaluation on Day 28. After that, blood and urine samples on suramin-dosing subjects will continue to collect on Days 56、84、112 and 140. Subjects receiving placebo will complete the study on Day 28 if no AE is observed, or follow up till the adverse event (AE) return to normal or stabilize if AE is detected. Blood and urine samples will be tested by a validated LC/MS method for pharmacokinetic study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.。
Placebo is 0.9% sodium chloride injection.
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGNumber of subjects with adverse events
Adverse events
Time frame: [ Day 1 to Day 140 ]
the area under the plasma concentration-time curve (AUC) from time zero to the time of the last measurable concentration (AUC0-t) of suramin sodium
Pharmacokinetics parameters
Time frame: [ Day 1 to Day 140 after study drug administration ]
the AUC from time zero to infinity (AUC0-inf) of suramin sodium
Pharmacokinetics parameters
Time frame: [ Day 1 to Day 140 after study drug administration ]
maximum plasma concentration (Cmax ) of suramin sodium
Pharmacokinetics parameters
Time frame: [ Day 1 to Day 140 after study drug administration ]
half life (t1/2) of suramin sodium
Pharmacokinetics parameters
Time frame: [Day 1 to Day 140 after study drug administration ]
clearance (CL) of suramin sodium
Pharmacokinetics parameters
Time frame: [ Day 1 to Day 140 after study drug administration ]
apparent volume of distribution(Vd) of suramin sodium
Pharmacokinetics parameters
Time frame: [ Day 1 to Day 140 after study drug administration ]
the amount of drug excreted into the urine from time zero to time 7 days(Ae0-t) of suramin sodium
Pharmacokinetics parameters
Time frame: [ Day 1 to Day 7 after study drug administration ]
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