Ascending single dose study of the safety, tolerability, and pharmacokinetics of PRM-151 administered to healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF)
Completed
- Conditions
- anti-fibrose (meerdere indicaties)disturbed wound healingexcessive scar formation10018073
- Registration Number
- NL-OMON33156
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
Healthy subjects: healthy, age: 18-55 yrs; BMI:18-33 kg/m2;
IPF Patients: IPF diagnosis, FVC>45% corrected for age, DLCO 40-80%, age: 18-72, BMI:18-33 kg/m2;
Exclusion Criteria
Healthy subjects: Active inflammation; acute or chronic disease; positive drug screen
IPF Patients: amyloidosis, connective tissue disorder, COPD, tuberculosis, cystic fibrosis, acute disease state, positive drug screen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tolerability will be evaluated from reported adverse events,<br /><br>scheduled physical examinations, vital signs, 12-lead ECGs, and clinical<br /><br>laboratory test results.</p><br>
- Secondary Outcome Measures
Name Time Method