Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Civi Biopharma, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects must be greater than or equal to 18 years of age
Subjects must have a diagnosis of Systemic Sclerosis
Subjects must have a diagnosis or history of Raynaud's Phenomenon
Subjects must have a minimum of 10 symptomatic Raynaud's Phenomenon attacks
Female subjects of childbearing potential and male subjects must agree to use contraception for the duration of the study
Subjects must be willing and able to comply with the study requirements and give informed consent for participation in the study
You may not be if
Female subjects who are pregnant or breastfeeding
Subjects with systolic blood pressure \<85 mmHg
Subjects with an estimated glomerular filtration rate \<30 mL/min/1.73 m2
Subjects with Child-Pugh Class B or Class C liver disease or an alanine aminotransferase and/or aspartate aminotransferase value \>3 × the upper limit of normal at screening.
Subjects with gangrene, digital ulcer infection, or requirement of cervical or digital sympathectomy
Subjects with intractable diarrhea or vomiting
Subjects with a risk of clinically significant bleeding events including those with coagulation or platelet disorders
Subjects with a history of major trauma or hemorrhage
Subjects with clinically significant chronic intermittent bleeding such as active gastric antral vascular ectasia or active peptic ulcer disease
Subjects who have had any cerebrovascular events
Subjects with a history of myocardial infarction or unstable angina within 6 months of screening
Subjects with acute or chronic congestive heart failure
Subjects with a history of life-threatening cardiac arrhythmias
Subjects with a history of hemodynamically significant aortic or mitral valve disease
Subjects with more than mild restrictive or congestive cardiomyopathy uncontrolled by medication or implanted device.
Subjects with known pulmonary hypertension, pulmonary arterial hypertension, or pulmonary veno-occlusive disease
Subjects with a history of significant restrictive lung disease defined as forced vital capacity \<45% predicted and diffusing capacity of the lungs for carbon monoxide \<40% predicted (uncorrected for hemoglobin).
Subjects with a history of cervical or digital sympathectomy
Subjects with scleroderma renal crisis
Subjects with a concomitant life-threatening disease with a life expectancy \<12 months
Subjects who have a clinically significant disorder, that in the opinion of the Investigator, could contraindicate the administration of study drug, affect compliance, interfere with study evaluations, or confound the interpretation of study results
Subjects who have taken or are currently taking any parenteral, inhaled, or oral prostacyclin or prostacyclin receptor agonists
Subjects must not initiate dosing of oral, topical, or intravenous (IV) vasodilators or if currently receiving any vasodilator must have been stably medicated
Subjects with any history of acetaminophen intolerability
Subjects with any malignancy that requires treatment during the study period, that has required treatment within 1 year of screening, or that is currently not in remission.
Subjects who have used any investigational medication or device for any indication within 30 days or 5 half-lives (whichever is longer)
