First-time-in-Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699

PHASE1TerminatedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 13, 2018

Primary Completion Date

May 2, 2019

Study Completion Date

May 2, 2019

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

Placebo

Placebo will be administered as a matching oral solution or matching capsule to study drug GSK3358699, during Part A and C once daily

DRUG

GSK3358699

GSK3358699, will be administered from 1 mg to 45 mg as an oral solution (1 to 10 mg) or as a capsule (3 to 45 mg), in Part A, B and Part C once daily.

BIOLOGICAL

GM-CSF

The GM-CSF will be administered as an intravenous infusion to subjects as 60 microgram per meter\^2 in Part A (Day 1) and Part C (Day 14).This will be administered for 2 hours approximately, no later than 24 hours post -dose of the GSK3358699 or placebo in Part C

BIOLOGICAL

LPS

LPS will be administered as an intravenous injection to subjects not exceeding 0.75 nanogram per kilogram in Part A (Day 1) and Part C (Day 14). This will be administered no later than 24 hours post -dose of the GSK3358699 or placebo in Part C.

OTHER

Cantharidin

This will be applied as a topical application with 0.7% cantharidin liquid which will be diluted with acetone to 0.2%.

Trial Locations (1)

CB2 2GG

GSK Investigational Site, Cambridge

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03426995 - First-time-in-Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699 | Biotech Hunter | Biotech Hunter