Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Attgeno AB
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Willing and able to give written informed consent for participation in the study
Healthy male and female subjects aged 18 to 45 years inclusive at screening
Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m\^2 at screening
Clinically normal medical history, physical findings, ECG and laboratory values
Male subjects and women of non-childbearing potential may be included in the study. Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP. Their female partner of child-bearing potential must use contraceptive methods.
Women of non-childbearing potential are defined as pre-menopausal females who are sterilised or postmenopausal
You may not be if
History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, might interfere with the drug absorption, distribution, metabolism or excretion of the drug or influence the results or the subject's ability to participate in the study
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP
Malignancy within the past 5 years
Any planned major surgery within the duration of the study
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV)
Women who are pregnant or who are breast feeding
Known patent foramen ovale or other cardiac phenomenon putting the subject at risk in the study
Presence of history of Raynaud Syndrome
After 10 minutes supine rest at the time of screening, any vital sign values outside the following ranges: Systolic blood pressure \<90 or \>140 mmHg, or Diastolic blood pressure \<50 or \>90 mmHg, or Pulse \<40 or \>90 bpm
Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator
Known history of migraine or frequent headache of other genesis (in average \>1 episode of grade 2 (CTCAE v5.0, headache per week)
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to PDNO
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity to the local anaesthesia planned to be used in the study
Known hypersensitivity to propanediol
Veins unsuitable for CVC and arterial cannula insertion
Failure to perform the FeNO measurement at screening
FeNO level ≥ 30 ppb
Within 1 month prior to Screening received continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs), novel oral anticoagulants (NOACs), warfarin, clopidogrel, or acetylsalicylic acid
Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals within 2 weeks prior to the (first) administration of IMP
Planned treatment or treatment with another investigational drug within 3 months prior to Day -1
Current smokers or users of nicotine products
Positive screen for drugs of abuse or alcohol
Presence or history of alcohol abuse or excessive intake of alcohol
Presence or history of drug abuse, as judged by the Investigator
History of, or current use of, anabolic steroids
Excessive caffeine consumption defined by a daily intake of \>5 cups of caffeine containing beverages
Intake of xanthine and/or taurine containing energy drinks at the day of screening.
Plasma donation within one month of screening or blood donation
Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
Previous confirmed COVID-19 that required hospitalisation
Signs or symptoms probably consistent with COVID-19 disease within the last 7 days prior to Visit 2 or close contact with confirmed COVID-19 patient within the last 7 days prior to Visit 2, as judged by the Investigator
Positive result for ongoing SARS-CoV-2 presented at Visit 2
Clareo Health | A First-in-Human Study to Assess the Safety and Tolerability of PDNO
