This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind, placebo controlled, randomized study design. The influence of food on the pharmacokinetics of HRS-2261 and the effects of HRS-2261 on CYP3A4 metabolic enzymes will also be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
HRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose.
HRS-2261 oral tablet, oral, BID. Matching placebo to HRS-2261, oral, BID.
The second hospital of Anhui Medical University
Hefei, Anhui, China
Number and severity of treatment emergent adverse events (TEAEs)
Number and severity of TEAEs collected from dosing until follow up 7 days after last dose
Time frame: up to 7 days after the last dose
Area under the curve (AUC)
To assess AUC of single and multiple ascending oral doses of HRS-2261
Time frame: up to 7 days after the last dose
Maximum plasma concentration (Cmax)
To assess Cmax of single and multiple ascending oral doses of HRS-2261
Time frame: up to 7 days after the last dose
Area under the curve (AUC) under fed conditions
To assess AUC of a single oral dose of HRS-2261 under fed conditions
Time frame: up to 7 days after the last dose
Maximum plasma concentration (Cmax) under fed conditions
To assess Cmax of a single oral dose of HRS-2261 under fed conditions
Time frame: up to 7 days after the last dose
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