First-in-human Clinical Trial Evaluating CUR-N399 in Healthy Volunteers.
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
The purpose of the trial is to evaluate CUR-N399, a PI4KB inhibitor, in a first-in-human
trial to evaluate the safety, tolerability and pharmacokinetics profile of single and
multiple ascending doses in healthy adults.
In the SAD part of the trial, single oral doses of CUR-N399 will be administered in 5
sequential cohorts. In all cohorts, safety and PK will be assessed before and after dose.
Exploratory nasopharyngeal swab for assessment of airway infectants will be performed before
dose and in the morning of Day 3.
In SAD part Cohort 4: A urine sample will be taken from the first morning void on Day 1 and
urine will be collected for potential quantification of CUR-N399 (and metabolites) during the
first 24 hours post-dose.
The MAD part of the trial will explore multiple ascending dosing of CUR-N399. The initial
dose, dose escalation and dosing schedule will be based on emerging knowledge of safety,
tolerability and PK of CUR-N399 observed in the SAD part of the trial. CUR-N399 will be
administered in 3 sequential cohorts. An additional MAD cohort will evaluate CUR-N399 in
older adults ≥65 years.
All SAD and MAD cohorts will evaluate 8 subjects. Within each cohort, subjects will be
randomised in a 3:1 ratio to receive CUR-N399 (n=6) or placebo (n=2) in a blinded fashion.