A first time in man study of NST-1024
A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects with Elevated Triglycerides. This will be a double-blind, randomised, placebo-controlled, single and multiple oral dose study conducted in 2 parts. In part A up to 6 cohorts of 8 healthy volunteers will receive single ascending doses of NST-1024 or matching placebo. I part B up to 4 cohorts of 10 otherwise healthy volunteers, with elevated triglycerides will receive daily multiple ascending doses of NST-1024 for 14 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
Covance Leeds Clinical Research Unit
Leeds, West Yorkshire, United Kingdom
Safety and tolerability
incidence and severity of adverse events
Time frame: 4 weeks
AUC
Area under the PK curve
Time frame: 3-17 days
Cmax
Maximum plasma concentration
Time frame: 3-17 days
Half life
time to reduction in plasma levels by 50%
Time frame: 3-17 days
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