NCT06188507

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK3996401 Following Dosing With GSK4347859 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3996401 Following Single and Multiple Ascending Doses of GSK4347859 in Healthy Participants

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a first time in human (FTiH) study which means that this is the first time that GSK4347859 is given to humans. The study is designed to investigate the safety, tolerability, and concentration of GSK3996401 (the activated form of GSK4347859) in the blood following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GSK4347859 in healthy participants. Part 1 consists of 2 planned cohorts with up to 4 treatment periods in each and is expected to have up to 8 dose levels. Part 2 will investigate 14 days of repeat dosing in 3 cohorts with 3 dose levels.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	GSK4347859	GSK4347859 will be administered
DRUG	Placebo	Placebo will be administered

Timeline

• Start date: 2024-01-12
• Primary completion: 2026-07-14
• Completion: 2026-07-14
• First posted: 2024-01-03
• Last updated: 2025-10-03

Locations

2 sites across 1 country: United Kingdom