Full name

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

NCT Number
NCT06188507
Geography
Non-US
Locations

United Kingdom

Primary Endpoints
  • Part 1 - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs). Up to Day 15,Part 2 - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs). Up to Day 30
  • Part 1 - Number of Participants with Clinically Significant Changes in Haematology. Up to Day 15
  • Part 2 - Number of Participants with Clinically Significant Changes in Haematology. Up to Day 30
  • Part 1 - Number of Participants with Clinically Significant Changes in Clinical Chemistry. Up to Day 15
  • Part 2 - Number of Participants with Clinically Significant Changes in Clinical Chemistry. Up to Day 30
  • Part 1 - Number of Participants with Clinically Significant Changes in Laboratory Values for Urinalysis. Up to Day 15
  • Part 2 - Number of Participants with Clinically Significant Changes in Urinalysis. Up to Day 30
  • Part 1 - Number of Participants with Clinically Significant Changes in Vital Signs. Up to Day 15
  • Part 2 - Number of Participants with Clinically Significant Changes in Vital Signs. Up to Day 30
  • Part 1 - Number of Participants with Clinically Significant Changes in 12 Lead Electrocardiogram Readings. Up to Day 15
  • Part 2 - Number of Participants with Clinically Significant Changes in 12 Lead Electrocardiogram Readings. Up to Day 30
  • Part 1 - Number of Participants with Clinically Significant Changes in 24 Hour Telemetry. Up to Day 2
  • Part 2 - Number of Participants with Clinically Significant Changes in 24 Hour Telemetry. Up to Day 15
Order
2
Disease
Menu title
A First Time in Human Study to Evaluate the Safety and Tolerability of GSK3996401 Following Dosing With GSK4347859 in Healthy Participants
Version
Phase
1
Status
Recruiting