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Monoclonal Antibodies

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 (SPAN Trial)

Phase 1

Waitlist Available

Research Sponsored by ViiV Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 14 compared with baseline (day -1)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called VH3810109 in healthy adults. The study aims to see how safe and tolerable the drug is and how it moves through and affects the body over several months.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection
HIV Suppression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14 compared with baseline (day -1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 14 compared with baseline (day -1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 compared with baseline (day -1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With >= Grade 2 AEs Following IV Administration of VH3810109 (Part 2)

Number of Participants With Grade 2 or Higher (>=) Adverse Events (AEs) Following SC Administration of VH3810109 (Part 1 and Part 3)

Number of Participants With Grade 2 to 4 Elevated ALT/AST Values Following VH3810109 IV Administration (Part 2)

+4 more

Secondary study objectives

AUC From Time Zero to Time t (AUC[0-t]) of VH3810109

Apparent Terminal Phase Half-life (t1/2) of VH3810109

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) of VH3810109

+24 more

Side effects data

From 2023 Phase 1 trial • 24 Patients • NCT05291520

13%

Muscle tightness

13%

Medical device site dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Part 2 Group: VH3810109 60 mg/kg [IV]

Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]

Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC]Experimental Treatment2 Interventions

Participants in this group received a single subcutaneous (SC) dose of VH3810109 3000 mg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.

Group II: Part 2 Group: VH3810109 60 mg/kg [IV]Experimental Treatment1 Intervention

Participants in this group received a single intravenous (IV) dose of VH3810109 60 mg/kg at Day 1 and were followed up to 24 weeks.

Group III: Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC]Experimental Treatment2 Interventions

Participants in this group received a single subcutaneous (SC) dose of VH3810109 20 mg/kg co-administered with rHuPH20 at Day 1 and were followed up to 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VH3810109

2022

Completed Phase 1

~30

rHuPH20

2019

Completed Phase 2

~920