Pharmacokinetics of the Monoclonal Antibody, Sotrovimab, in Healthy Participants Following IM Administration at Different Injection Sites.

Sotrovimab is a recombinant human monoclonal antibody for the early treatment of mild-to-moderate COVID- 19. A phase I, open-label, randomized, parallel-group study was conducted to investigate the pharmacokinetics, relative bioavailability, safety, and tolerability of two concentrations of sotrovimab administered intramuscularly at different injection sites in healthy volunteers. The study consisted of three parts (A, B, and C) and the pharmacokinetic results from Part A are reported herein.

A phase 1 study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics of VIR-2482: a monoclonal antibody for the prevention of severe influenza A illness.

The objective of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of VIR-2482 in healthy adult subjects. A phase 1, first-in-human, randomized, double-blind, placebo-controlled dose-escalation study was conducted. One hundred participants were allocated to four cohorts (60 mg, 300 mg, 1,200 mg, and 1,800 mg).

Pharmacokinetics, Disposition, and Biotransformation of [C]Lenacapavir, a Novel, First-in-Class, Selective Inhibitor of HIV-1 Capsid Function, in Healthy Participants Following a Single Intravenous Infusion.

Background And Objective: Lenacapavir (LEN) is a novel, first-in-class, multistage, selective inhibitor of human immunodeficiency virus type 1 (HIV-1) capsid function recently approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection. The purpose of this multicohort study was to evaluate the pharmacokinetics, metabolism, excretion, safety, and tolerability of LEN following a single intravenous (IV) infusion of 10 mg LEN or 20 mg [C]LEN in healthy participants.

Methods: Twenty-one healthy adult participants were enrolled into the study and received either a single IV dose of 10 mg LEN (n = 8 active, n = 3 placebo; cohort 1) or a single IV dose of 20 mg [C]LEN containing 200 µCi (n = 10; cohort 2).

An investigation of the associations between trauma exposure, racial stereotypes, and racist beliefs.

Objective: Given the concerning rise in hate crimes in recent years, it is critical to better understand factors associated with racist beliefs. As suggested by terror management theory (TMT), trauma exposure and posttraumatic stress symptoms (PTSS) may activate existential distress and anxiety, which may strengthen worldviews, including prejudiced beliefs (Greenberg & Kosloff, 2008; Weise et al., 2012).

Pharmacokinetics, Safety, and Tolerability of Anti-SARS-CoV-2 Monoclonal Antibody, Sotrovimab, Delivered Intravenously or Intramuscularly in Japanese and Caucasian Healthy Volunteers.

Background And Objective: Sotrovimab 500 mg administered by a single intravenous (IV) infusion has been granted special approval for emergency use in Japan for treatment of SARS-CoV-2 infection in adults and children aged ≥ 12 years weighing ≥ 40 kg. This Phase 1, single-dose study investigated the pharmacokinetics, safety, and tolerability of IV or intramuscular (IM) sotrovimab 500 mg doses versus placebo in healthy Japanese and Caucasian volunteers.

Methods: This was a two-part, Phase 1, randomized, placebo-controlled, single-blind study.