This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics (PK) of multiple doses of VV913 in Chinese healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally.
6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGIncidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline to 6 days after the last administration
Cmax
maximum observed plasma concentration
Time frame: Baseline to 72 hours after the last administration
AUC0-∞
area under the plasma concentration time curve from time zero to infinity
Time frame: Baseline to 72 hours after the last administration
Tmax
time at which Cmax occurs
Time frame: Baseline to 72 hours after the last administration
t1/2
half-life of elimination
Time frame: Baseline to 72 hours after the last administration
Apparent Clearance Rate(CL/F)
apparent clearance
Time frame: Baseline to 72 hours after the last administration
Vd/F
apparent volume of distribution during the terminal phase
Time frame: Baseline to 72 hours after the last administration
λz
elimination rate constant
Time frame: Baseline to 72 hours after the last administration
AUC0-24h
area under the plasma concentration time curve from time zero to 24h
Time frame: Baseline to 72 hours after the last administration
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mean Resident Time
mean Resident Time from time zero to infinity/the last
Time frame: Baseline to 72 hours after the last administration
Rac
Accumulation Ratio of VV913
Time frame: Baseline to 72 hours after the last administration