NCT05206019

Study to Evaluate Pharmacokinetic and Safety of Albuvirtide Between Intravenous Drip and Intravenous Injection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Frontier Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-center,randomized,open, single-dose, parallel-design study, which will be only enrolled Chinese healthy volunteers.

Detailed description

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.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
DRUG	Albuvirtide	Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)

Timeline

• Start date: 2022-02-16
• Primary completion: 2022-04-17
• Completion: 2022-05-02
• First posted: 2022-01-25
• Last updated: 2023-01-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study