A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants

Phase 1 Completed 24 enrolled ViiV Healthcare

Non-randomizedSequentialOpen-labelTreatment

Summary

An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.

Timeline

Start: 2022-02-23
Primary completion: 2023-04-10
Completion: 2023-04-10

Publications

Leone PA, Losos J, Wannamaker P, D'Agostino R, Warwick-Sanders M, Ghita GL, Wilches V, Donatti C, Brown K, Gandhi Y. VH3810109 (N6LS) broadly neutralizing antibody safety, pharmacokinetics, and anti-drug antibody incidence in adults without HIV: phase 1 SPAN study results. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0025825. doi: 10.1128/aac.00258-25. Epub 2025 Jul 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	VH3810109	Unknown	20 mg/kg	Subcutaneous
Subject	VH3810109	Unknown	60 mg/kg	Subcutaneous
Subject	VH3810109	Unknown	3000 mg	Subcutaneous
Background	rHuPH20	Protein / enzyme biologic	2000 unknown	Subcutaneous

A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants

Summary

Timeline

Publications

Drugs

Indications