This is a randomized, double-blind, placebo-controlled, 2-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SR1375 in healthy volunteers
This study is a phase 1,randomized, double-blind, placebo-controlled, 2-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SR1375 in healthy volunteers. The study is divided into two parts, Part A (single ascending dose \[SAD\]) and Part B (multiple ascending dose \[MAD\]). In Part A, the scheduled dose cohorts include 1, 3, 10, 30, 100, and 200 mg; in Part B, the planned dose range will be 5, 15, and 50 mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
The subject will be orally administered by single and multiple doses of SR1375 capsules with 240 ml water
The subject will be orally administered by single and multiple doses of matching capsules with 240 ml water
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
AE (Adverse Event)
Incidence, type and severity and causality of AEs (including withdrawals due to safety or tolerability reasons)
Time frame: Up to Day 32
Plasma PK : Tmax
Plasma PK : Time to Cmax (Tmax)
Time frame: Up to Day 32
Plasma PK : Ctrough
Plasma PK : Trough concentrations (Ctrough) (Part B only)
Time frame: Up to Day 32
Plasma PK : AUC0-t
Plasma PK : Area under the concentration-time curve from 0 to time of last quantifiable
Time frame: Up to Day 32
Plasma PK : AUC0-∞
Plasma PK : Area under the concentration-time curve from t=0 to infinity (AUC0-∞)
Time frame: Up to Day 32
Urine PK: Ae
Urine PK: Cumulative amount of unchanged drug excreted in urine (Ae)
Time frame: Up to Day 4
Urine PK: CLr
Urine PK: Renal clearance (CLr)
Time frame: Up to Day 4
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