This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers.
30 Chinese volunteers will be enrolled to assess the pharmacokinetic and safety of Albuvirtide in two different Administration methods. All subjects are required to collect PK blood samples before and after administration. 30 healthy subjects will be randomized into three cohorts ( cohorts A, B and C) in 1:1:1 ratio, with 10 subjects in each cohort. The subjects will receive a single dose of 320 mg of albuvirtide by iv infusion for 45 min or by iv bolus for 0.5 min or 3 min, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
The Second Hospital of Anhui Medical University
Hefei, China
Area under curve
The area under the plase of the last measurable The area under the curve of the last measurable concentration (AUCt)
Time frame: Day 0-Day 57
Peak concentration
Maximum observed plasma concentration (Cmax)
Time frame: Day 0-Day 57
Peak time
Time to Cmax ( Tmax)
Time frame: Day 0-Day 57
half-time
Time for blood concentration to drop by half-time(t1/2)
Time frame: Day 0-Day 57
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Time frame: Day 0-Day 63
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