SPAN
Status:Ongoing
Phase:I
Principal Investigator(s):
Objective:A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults
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.
Last updated September 20, 2022
Prevention Option(s):Antibody Related Research
Study Design:Open label
Arms and Assigned Interventions
DescriptionExperimental: Part 1: VH3810109 + rHuPH20
Healthy participants will receive a single SC dose of VH3810109 injection with rHuPH20.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part 2: VH3810109
Healthy participants will receive a single IV dose of VH3810109 injection.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT05291520
Trial Sponsors:
ViiV
Start Date
End Date
February 22, 2022
February 23, 2023
Enrollment:20
Age range:
18 Years ↔
65 Years
Population:Cisgender Men, Cisgender Women