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
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Part I In Part I of the study, 4 subjects per cohort will first receive a 30 minutes iv
infusion of placebo followed by a 1 hour iv infusion of PDNO in parallel with a continuous
infusion of a sodium bicarbonate carrier buffer.
A total of 7 sequential cohorts with the following tentative dose levels are planned: 0.3,
1.0, 3.0, 10, 30, 60 and 120 nmol/kg/min. Up to 2 additional dose levels can be explored,
tentatively 180 and 240 nmol/kg/min. Lower, intermediate doses (e.g. 90 nmol/kg/min) or
repeated doses may also be given, based on the safety and tolerability of the drug if
recommended by the iSRC. The maximum dose in the study will not exceed 240
nmol/kg/min.Subjects will come for 4 visits to the clinic. Screening (Visit 1) will take
place from Day -28 to Day -1 and will include the subjects' signing of the informed consent
and an eligibility check. At Visit 2, subjects will be admitted to the clinic on Day -1 for
pre-dose assessments. The subjects will be carefully monitored by clinical staff during and
after infusion. Vital signs (including pulse oximetry) and ECG will be checked at regular
intervals. During the infusion, blood pressure will be continuously controlled via
intra-arterial blood pressure monitoring.
In all cohorts, safety, tolerability and PD exposure will be assessed before, during and
after the PDNO iv infusion. FeNO monitoring will be also be performed.
Part II Part II of the study will explore ascending doses of PDNO in 2 cohorts. In each
cohort, 4 subjects will first receive a 30 minutes iv infusion of placebo followed by iv
infusions of PDNO in 3 ascending doses in parallel with a continuous infusion of a sodium
bicarbonate carrier buffer. Each of the first 2 dose levels in each cohort will be iv infused
for 30 minutes whereas the highest dose level will be iv infused for 3 hours. To avoid any
potential rebound effect, there will be no stabilisation period between either dose
The planned dose levels are: 1, 3 and 10 nmol/kg/min in cohort 1 and 30, 60 and 120
nmol/kg/min in cohort 2. The actual doses given in Part II will be based on emerging
knowledge of safety and tolerability of PDNO observed in Part I of the study. The maximum
dose in Part II will not exceed the highest dose given in Part
Experimental: The experimental arm PDNO in increasing doses
The Investigational medicinal product, PDNO is given intravenously, in part 2 the doses is increased twice.
Placebo Comparator: Placebo
The placebo comparator, NaCl is given intravenously, before the PDNO is given.
Drug: - PDNO
PDNO is the experimental drug
Drug: - Sodium chloride
Sodium chloride is just as placebo
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
CTC Clinical Trial Consultants AB
Uppsala, , 75185
Folke Sjöberg, MD