This study was a randomized, double-blind, placebo-controlled phase I clinical trial of TQH3821 in adult healthy subjects, which plans to recruit 72 healthy subjects. The main purpose was to evaluate the safety and tolerance of different doses of TQH3821 or in combination with methotrexate tablets after single and multiple administration in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
TQH3821 tablets is an Interleukin-1 receptor-associated kinase 4 inhibitor that exhibits a high degree of inhibitory activity against IRAK4 kinase.
TQH3821 tablets (Placebo) is a placebo produced with reference to TQH3821 tablets, which has no effect on IRAK4 kinase.
Methotrexate tablets is a folic acid antagonist, which belongs to an anti-rheumatic drug to improve the condition
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Adverse events (AEs)
Safety and tolerability are assessed by the incidence of adverse events and its severity caused by the study drug during or after dose.
Time frame: The first day of the first administration until 8 days after the last administration
Peak concentration (Cmax)
Peak concentration (Cmax) refers to the highest blood drug concentration achieved after administration called blood drug peak concentration (referred to as peak concentration), which is related to the dose administered, the route of administration, the number of times of administration and the time of arrival
Time frame: Pharmacokinetics blood samples were collected from 60 minutes before administration on Day 1 to 168 hours after the last administration.
Plasma concentration-area under time curve (AUC0-t)
The area under the plasma concentration-time curve from the beginning of the first administration to the last measurable concentration point
Time frame: Pharmacokinetics blood samples were collected from 60 minutes before administration on Day 1 to 168 hours after the last administration.
Plasma concentration-area under time curve (AUC0-∞)
Extrapolated from the first administration to the area under the plasma concentration-time curve to infinity
Time frame: Pharmacokinetics blood samples were collected from 60 minutes before administration on Day 1 to 168 hours after the last administration.
High sensitivity C-reactive protein (hs-CRP)
Hypersensitive C-reactive protein is a kind of C-reactive protein in plasma. It is a non-specific marker of acute systemic inflammatory response synthesized by the liver
Time frame: Multiple Administration Dose: Blood samples were collected from 60 minutes before administration on Day 1 to 192 hours after the consecutive administration.
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