Dataset from Randomized, Double-blind, Placebo Controlled Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses (Intravenous Bolus) and Constant Intravenous Infusion Over 7 Days of GSK3335065 in Healthy Adult Subjects

GSK3335065 is being developed as a treatment for acute pancreatitis with the intent of
reducing 3-hydroxykynurenine (3HK) levels to the normal range (or lower) and maintaining them
at this level throughout the treatment period. This study will utilize an adaptive design and
is divided into 3 parts. Part A will consist of 8 cohorts (1-8) and is Single Ascending Dose
(SAD) of GSK3335065 by IV bolus in males. Part B will be initiated after completion of dosing
in Part A. It will involve ascending IV bolus doses of GSK3335065 followed by IV constant
infusion for 7 days in males and will consist of four cohorts (9-12). Part C consists of a
single dose of GSK3335065 by IV bolus (cohort 13), and a single dose followed by continuous
infusion over 7 days (cohort 14) in females of non-child bearing potential (WONCBP). Total 64
subjects will be evaluated in the study of which Part A will include 16 healthy male
subjects, Part B will include 32 healthy male subjects and Part C will include 16 WONCBP. In
Part A, cohorts 1 and 2 will last up to 19 weeks and cohorts 3 to 8 will last up to 7 weeks
and Part B will last up to 13 weeks. In Part C cohort 7 will last up to 7 weeks and cohort 8
will last for 13 weeks.