Hyaluronidase-enhanced subcutaneous delivery of bNAbs: a phase 1 randomized controlled clinical trial in HIV-uninfected women.

ABSTRACT: Broadly neutralizing antibodies (bNAbs) offer a promising strategy for HIV prevention. Subcutaneous (SC) administration is more feasible than intravenous delivery but may be limited by prolonged administration times and multiple injections. Here we report a pharmacokinetic (PK) modelling study, an unspecified exploratory analysis that involved 57 HIV-negative African women (median age 25 years; BMI range 18.1-39.3 kg/m²) enrolled in the CAPRISA 012B trial (PACTR202003767867253, total participants n = 76). A predefined sub-analysis directly comparing the 20 mg/kg dose level of ENHANZE™ drug product (EDP) versus no-EDP was conducted in a subset of participants (n = 5 with EDP, n = 5 without). CAP256V2LS and VRC07-523LS-potent HIV-1 bNAbs targeting conserved envelope epitopes-were administere

SUBMITTER: Mahomed S 

PROVIDER: S-EPMC12402148 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature