The trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-718 injection in Chinese obese subjects.
The trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-718 injection in Chinese obese subjects. The study consists of three dose groups, each of which is planned to include 12 subjects (9 receiving the study drug and 3 receiving placebo), for a total of 36 patients. Subjects will receive 12 weeks(for cohort 1 and 2) or 18 weeks(for cohort 3) of treatment after screening and complete 8 weeks of safety follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Peking University Third Hospital
Beijing, Beijing Municipality, China
Incidence of Treatment-Emergent Adverse Events
Time frame: From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit (20 weeks for cohort 1 and cohort 2 or 26 weeks for cohort 3)
Pharmacokinetic profile
Cmax
Time frame: From the first dose (Day 1 ) of study drug until week 12 (for cohort 1 and cohort 2) or week 18(for cohort 3)
Pharmacokinetic profile
Tmax
Time frame: From the first dose (Day 1 ) of study drug until week 12(for cohort 1 and cohort 2) or week 18(for cohort 3)
Pharmacokinetic profile
Area under the concentration-time curve over dosing interval(AUC0-tau)
Time frame: From the first dose (Day 1 ) of study drug until week 12(for cohort 1 and cohort 2) or week 18(for cohort 3)
Pharmacokinetic profile
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC0-last)
Time frame: From the first dose (Day 1 ) of study drug until week 12(for cohort 1 and cohort2) or week 18(for cohort 3)
Pharmacokinetic profile
t1/2
Time frame: From the first dose (Day 1 ) of study drug until week 12(for cohort 1 and cohort 2) or week 18(for cohort3)
Proportion of participants with ≥5% weight loss
Time frame: week 12 (for cohort 1 and cohort2) or week 18(for cohort 3)
Change in body weight from baseline
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Time frame: Week12(for cohort 1 and cohort 2) or week 18(for cohort 3)
Change in Fasting Plasma Glucose(FPG) from baseline
Time frame: week 12(for cohort 1 and cohort 2) or week 18(for cohort 3)