To evaluate the tolerability and safety of a single oral dose of ZL-65 tablets in healthy adult trial participants through dose escalation; and to preliminarily assess the pharmacokinetic and pharmacodynamic characteristics of a single oral dose of ZL-65 tablets.Exploring the impact of food intake on the PK of orally administered ZL-65 tablets in healthy adult trial participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
ZL65 Tablet 5mg ZL65 Tablet 10mg ZL65 Tablet 25mg ZL65 Tablet 50mg ZL65 Tablet 75mg ZL65 Tablet 100mg ZL65 Tablet 125mg
ZL65 Placebo Tablet 5mg ZL65 Placebo Tablet 10mg ZL65 Placebo Tablet 25mg ZL65 PlaceboTablet 50mg ZL65 Placebo Tablet 75mg ZL65 Placebo Tablet 100mg ZL65 Placebo Tablet 125mg
Chengdu Xinhua Hospital
Chengdu, Sichuan, China
RECRUITINGIncidence of adverse events
Time frame: day 1 to day 7
ZL65 Pharmacokinetics (PK):Cmax
Time frame: 0-72hours
ZL65 Pharmacokinetics (PK):Tmax
Time frame: 0-72hours
ZL65 Pharmacokinetics (PK):AUC0-t
Time frame: 0-72hours
ZL65 Pharmacokinetics (PK):AUC0-∞
Time frame: 0-72hours
ZL65 Pharmacokinetics (PK):t1/2
Time frame: 0-72hours
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