This is a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of TRD205 after single and multiple doses and to evaluate the effect of food on TRD205 in healthy adult subjects.
This study consists of three parts: * Single ascending dose study * Multiple ascending dose study * Food effect study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
151
The first hospital of Jilin University
Changchun, Jilin, China
Treatment-Related Adverse Events
The safety and tolerability of TRD205 orally administered once and/or multiple times on an empty stomach in healthy subjects
Time frame: After a single dose and/or once daily for 10 consecutive doses
Area under the plasma concentration versus time curve (AUC)
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Time frame: After a single dose and/or once daily for 10 consecutive doses
Peak Plasma Concentration(Cmax)
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Time frame: After a single dose and/or once daily for 10 consecutive doses
time to peak(Tmax)
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Time frame: After a single dose and/or once daily for 10 consecutive doses
Elimination rate constant(Kel)
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
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Time frame: After a single dose and/or once daily for 10 consecutive doses
apparent volume of distribution(Vd)
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Time frame: After a single dose and/or once daily for 10 consecutive doses
elimination half life(T1/2)
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Time frame: After a single dose and/or once daily for 10 consecutive doses
Mean retention time(MRT)
To evaluate the pharmacokinetic characteristics of a single oral administration of TRD205 in healthy subjects on an empty stomach; To evaluate the pharmacokinetic characteristics of TRD205 orally administered multiple times in healthy subjects; Explore the impact of food on in vivo exposure to TRD205.
Time frame: After a single dose and/or once daily for 10 consecutive doses