A First-in-human Study to Assess the Safety and Tolerability of PDNO
Status:
Recruiting
Trial end date:
2021-12-15
Target enrollment:
Participant gender:
Summary
This is a first-in-human (FIH), single-blind, placebo-controlled, single-centre study
designed to assess the safety and tolerability of PDNO in healthy male and female subjects.
In addition, the exposure of 1,2 propanediol (PD) will be evaluated.
The study will be conducted in 2 parts:
Part I: single ascending dose (SAD), 7 cohorts, 30 minutes intravenous (iv) infusion of
placebo followed by 1 hour iv infusion of PDNO to assess safety, tolerability and PD exposure
in healthy male and female subjects.
Part II: ascending doses of PDNO in 2 cohorts, 30 minutes iv infusion of placebo followed by
3 ascending doses of PDNO in cohort 1 and 3 ascending doses of PDNO in cohort 2. The first 2
doses in each cohort will be iv infused for 30 minutes whereas the last will be iv infused
for 3 hours to assess safety, tolerability and PD exposure in healthy male and female
subjects.
If indicated by emerging data and recommended by the internal safety review committee (iSRC),
2 additional dose groups/cohorts (4+4 subjects) may be added to Part I and 1 dose
group/cohort (4 subjects) may be added to Part II.