The Second Hospital of Anhui Medical University
Hefei, China
NCT Number: NCT05206019
This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Hefei, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
Time frame: Day 0-Day 57
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
Maximum observed plasma concentration (Cmax)
Time frame: Day 0-Day 57
Time to Cmax ( Tmax)
Time frame: Day 0-Day 57
Time for blood concentration to drop by half-time(t1/2)
Time frame: Day 0-Day 63
Incidence of Treatment-Emergent Adverse Events
Frontier Biotechnologies Inc.
Industry
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