At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
PRM-151 +1 morebiological
Likely dose
PRM-151 10.0 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Masked, Sponsor-Unmasked, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRM-151 Administered Intravenously to Patients With Idiopathic Pulmonary Fibrosis
In Brief
A Phase 1 clinical trial evaluating PRM-151 and Placebo for Idiopathic Pulmonary Fibrosis. Completed, enrolled 21 participants across 3 sites in 2 countries.
Detailed Summary
The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesNetherlands, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartMar 2011
Primary CompletionJul 2012
TodayJul 2026
First PostedDec 6, 2010
Enrollment StartMar 29, 2011
Primary CompletionJul 2, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.6 years ago
Interventions
PRM-151biological
Intravenous PRM-151 administered over 30 minutes on study days 1, 3, 5, 8, and 15 at doses of 1.0, 5.0, or 10.0 mg/kg.
Placeboother
Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15.